Single Brain Death Examination Is Equivalent to Dual Brain Death Examinations

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1 Neurocrit Care (2011) 15: DOI /s ETHICAL MATTERS Single Brain Death Examination Is Equivalent to Dual Brain Death Examinations Panayiotis N. Varelas Mohammed Rehman Tamer Abdelhak Aashish Patel Vivek Rai Amy Barber Susan Sommer Jesse J. Corry Chethan P. Venkatasubba Rao Published online: 21 May 2011 Ó Springer Science+Business Media, LLC 2011 Abstract Background Although the new Practice Parameters for brain death support a single examination, there is paucity of data comparing its impact to dual brain death (DBD) examinations. Methods We reviewed all brain deaths in our hospital over a 39-month period and compared the optional single brain death (SBD) exam requiring an apnea and a mandatory confirmatory blood flow test to the DBD for organ function at the time of death, rate of donation, and cost. Results Thirty-six patients had a SBD and 59 DBD exams, without any of them regaining neurological functioning. There was no difference in serum electrolytes (except for higher Na + and Cl - in the SBD group), blood urea nitrogen, creatinine, blood gases, incidence of diabetes P. N. Varelas M. Rehman T. Abdelhak A. Patel V. Rai J. J. Corry C. P. Venkatasubba Rao Department of Neurology, Henry Ford Hospital, Detroit, MI, USA P. N. Varelas M. Rehman T. Abdelhak J. J. Corry Departments of Neurosurgery, Henry Ford Hospital, Detroit, MI, USA A. Barber Transplant Institute, Henry Ford Hospital, Detroit, MI, USA S. Sommer Gift of Life of Michigan, Ann Arbor, MI, USA P. N. Varelas (&) Henry Ford Hospital, K-11 & Henry Ford West Bloomfield Hospital, 2799 West Grand Blvd, Detroit, MI 48202, USA varelas@neuro.hfh.edu P. N. Varelas Department of Neurology, Wayne State University, Detroit, MI, USA insipidus, apnea completion, consent for donation, and organs recovered and transplanted. During the second BD exam, 35% of patients with DBD were on higher dose of vasopressors, but had lower systolic blood pressure (P = 0.046). For DBD patients, the mean interval between the two exams was 14.4 h, which contributed to a higher cost of $43, compared to SBD. There was a trend for increased consent rates (adjusted for age, race, and type of exam) when patients were declared by the neurointensivist service following a strict family approach protocol (P = 0.06). Conclusion SBD exam is easier, faster to perform, with no brain function recovery and leads to similar donation rates, equivalent or better organ function status at the time of BD and lower cost than conventional DBD exams. Keywords Brain death Single Critical care Cost effectiveness Organ donation Transplantation Introduction Definition of death in the United States of America is based on the Uniform Determination of Death Act (UDDA), which was adopted by most States with or without amendments. UDDA defines death as either the irreversible cessation of circulatory or respiratory function or the irreversible cessation of all functions of the entire brain, including the brainstem (also known as Brain Death [BD]) [1]. The word irreversible inherently implies an observation period long enough to assure that brain functions do not return; however, the recently updated Practice Parameters of Brain Death Determination in adults by the American Academy of Neurology (AAN) did not find sufficient evidence to determine the minimally acceptable

2 548 Neurocrit Care (2011) 15: observation period. Moreover, the same update recommends performing one neurological examination if a certain period of time has passed since the onset of the brain insult to exclude the possibility of recovery (in practice, usually several hours). Although this approach seems reasonable, there are no published data to support it and two neurological examinations are still required in many State statutes [2]. A single brain death (SBD) examination may offer several advantages. The most obvious is the shortening of the BD declaration time, which may decrease the incidence of multi-organ dysfunction in these critically ill patients, thereby increasing the number and quality of organs procured per donor. A parallel gain may be the lowering of institutional charges. This cost could potentially benefit donor families (who potentially could be penalized for being altruistic, if the process was unnecessarily longer and, thus, the cost higher) [3]. The potential disadvantages of SBD exam include the possibility that some of these patients may regain neurological function by the time of a second exam (which is the reason behind the two brain death exams mandate). Another disadvantage is the shortened grieving period that accompanies a SBD exam. Families need time to deal with a loved one s death. Shortening this critical stage could lead to decreased levels of trust between patients families and their care providers, thus lowering donor consent rates. In this study, we compared organ status at time of death, consent rates for donation, number of organs retrieved or transplanted, and hospital charges accrued between the conventional dual brain death (DBD) exams and a novel SBD exam. We also examined whether there was any difference in donation based on the hospital service performing the BD exam. Materials and Methods We retrospectively reviewed all BD determinations at Henry Ford Hospital between April 2006 and July The Hospital database was linked to the Gift of Life of Michigan (GOL) database (GOL is the official organ procurement organization for the state of Michigan). The hospital Institutional Review Board granted exempt protocol status for this study of dead patients. Before April 2006, the hospital policy mandated two separate BD exams, at least 6 h apart (for patients postcardiac arrest, the policy required two exams separated by at least 24 h). After April 2006, a new policy allowed a SDB exam in patients with catastrophic neurological injury (i.e., gun shot wound to the head or large intra- or extraaxial hemorrhages from trauma, poor-grade subarachnoid hemorrhage, large intracerebral hemorrhage, malignant ischemic stroke, extensive cerebral edema with signs of brain herniation, etc.). This optional SBD exam could be performed only by the Neuro-Service (Neurosciences- Intensive Care [NICU], Neurology and Neurosurgery). DBD exam could still be performed based on the admitting attending s preferences to allow a transition period between the old and new policies. To avoid any falsepositive BD declarations by the SBD exam, we adopted a cautious approach comprised the single clinical exam, an apnea test and a mandatory confirmatory cerebral blood flow test. A confirmatory test was still considered optional with DBD exams, as it had been in the old policy. If cardiac arrest was the cause of BD, a 24-h waiting period between the two exams was still mandated, and SBD exam was not an option. Demographic data, admission diagnoses, service performing the BD exams, Intensive Care Unit (ICU) where the patient was admitted, and time from admission to BD exams were extracted for all patients. In addition, we estimated the function of four other non-neurological organ systems at the time of BD. To assess cardiovascular function, we determined the heart rate and systolic blood pressure (SBP) at the time of SBD or second DBD exam, and the type and dose of pressors or inotropes during the first or second DBD exam or the SBD exam. To assess renal function, we measured serum electrolytes, blood urea nitrogen (BUN), and creatinine levels. To assess respiratory function, we examined arterial blood ph, PaO 2, and PaCO 2 at the conclusion of the apnea test. For endocrine function, we looked at the presence of diabetes insipidus (DI), which was defined as a rising Na + associated with polyuria (>200 ml/h) and low urine specific gravity (<1.005). As hypertonic sodium chloride was part of the anti-edema therapy, we also noted if such a treatment had been administered within 24 h from the last BD exam. GOL provided the information regarding consent rate, decoupling (in which the announcement of the patient s death to the family is separated in time from the request for donation; decoupling has been shown to increase consent for donation [4, 5]), time from obtaining consent to organ removal from the donor in the operating room, number of organs recovered, type and number of organs transplanted and tissue donated. We also examined whether improved consent rates were obtained when the NICU service was involved, since all NICU attendings and fellows adhered to the following stepwise communication process: (1) discussions were held in a quiet conference room, (2) discussions were conducted by the NICU service attending (or fellow in the attending s presence), and (3) the team and family together reviewed both the patient s hospital course and brain neuroimaging. During this last step, the meaning of BD and the BD evaluation process were clearly and thoroughly explained

3 Neurocrit Care (2011) 15: to the family before leaving the room and allowing the GOL representatives to approach the family for consent. This strict process was not necessarily followed by the various other admitting services. We also examined the cost of SBD compared to DBD. For cost analysis, Current Procedural Terminology (CPT) codes for brain Single Photon Emission Computer Tomography (SPECT), Transcranial Doppler (TCD), brain Computerized Tomographic Angiography (CTA), and Electroencephalogram (EEG) were used (78607, 93886, 70496, and 95822, respectively) to estimate both the technical and professional fees for these confirmatory tests. Mandatory confirmatory test costs in patients with SBD exam were compared to the cost of the extended ICU stay in DBD exam patients. Because not all patients with DBD exams required confirmatory tests, we applied a similar percentage to the patients with SBD exams (i.e., we estimated the cost of confirmatory tests only in those who theoretically would not have had one). We also applied the distribution of the specific tests of DBD exam patients to the SBD exam patients. SBD exam policy mandates the use of a cerebral blood flow test, therefore a CTA (the most expensive of the flow tests) was used as a substitute for the EEG test. Univariate and multivariate statistical analyses were performed. The demographic and other patient characteristics for the two groups (SBD and DBD) were compared using v 2 tests for the binary or categorical measures and two sample t tests for the continuous measures. In addition, regression analyses were done to adjust for the use of hypertonic saline when comparing for Na + and peak Na + levels or DI. When comparing patients for consent rate and number of organs procured or transplanted, logistic regression analyses were used to adjust for age, race, type of BD exam (single vs double), and service performing the final BD exam (the NICU service vs. other services). These two types of services were also compared using two sample t tests and v 2 tests for the four organ system measures. Results From our databases, we extracted 103 patients, but 95 were included in the final analysis (1 patient died after cardiac arrest before being declared BD, 2 patients died by Death by Cardiac Death, and 5 patients had incomplete records). SBD exam was performed in 36 patients and DBD exam in 59 patients. Table 1 presents the basic characteristics of the two groups. In four patients, SBD exam was performed by the Medical ICU or Surgical ICU services in violation of the protocol, but these patients were included in the analysis after reviewing the neuroimaging studies (catastrophic head traumas or non-survivable intracerebral hemorrhages), the completeness of BD documentation, the apnea test results, and the absence of flow in the confirmatory tests. The NICU service performed a SBD exam more frequently than the other services (odds ratio 7.8, 95% CI , P < 0.001). Table 2 presents the organ function, BD variables, and donation results. DI was observed in 55/95 (58%) of patients, but only 36/55 (65%) were treated (25/36 [69%] of them received arginine-vasopressin analogs and the rest only hypotonic fluids). At the time of BD exam, 7/95 (7.5%) patients were receiving hypertonic saline solutions. After adjusting for hypertonic saline use, there was no difference in DI between the two groups (P = 0.16), but Na + level at the time of death and peak Na + level still remained significantly higher in the SBD exam group (P < in both). There was no difference between the two groups in the dose of pressors or inotropes during the first BD exam. Despite the fact that 18/51 (35%) of patients with available data were on higher dose of pressors or inotropes during the second BD exam compared to the first, the mean SBP at time of death was significantly lower in the DBD group. Even after excluding these 18 patients, the remaining 33 patients (with unchanged doses of pressors or inotropes) still had significantly lower SBP at the time of the second BD exam compared to the 36 patients with SBD exam (mean SBP ± 24.3 mmhg vs ± 28.3 mmhg, P = 0.008). There was no difference in the type of confirmatory tests between patients with SBD or DBD exam. The majority (39/54, 75%) had SPECT. Eleven patients (21.2%) had TCD. Only one patient had EEG and another CTA, both with DBD exams. Although CTA is not a validated confirmatory test, this patient was admitted with high-grade subarachnoid hemorrhage and had a diagnostic CTA for detection of cerebral aneurysm, which revealed blood flow to the brain. When the patient met clinical criteria of brain death and the apnea test had been completed, repeat CTA found no cerebral blood flow. For this reason, the patient was kept in the analysis. The time interval between the two BD exams in those patients who had DBD exams was 14.4 ± 12.9 h. No patient with single or dual BD exams regained brain or brainstem function after an apnea test or a confirmatory test led to BD declaration. One patient was excluded from transplantation, and the family was never approached for donation. There was a trend for more transplanted livers in the SBD exam group. After adjusting for age and race, there was still no difference in the consent rate for donation (P = 0.76), organs procured (P = 0.37), or organs transplanted (P = 0.98) based on the number of BD exams. We repeated the analysis after excluding the 15 patients with cardiac arrest, since these patients could not have had a SBD exam. The results mirrored those in the whole cohort.

4 550 Neurocrit Care (2011) 15: Table 1 Comparison of patients who underwent single brain death exam to those who underwent dual brain death exams Demographics, admission diagnosis, and services units where the exams were performed SBD single brain death exam, DBD dual brain death exam, BD brain death, NICU Neurosciences Intensive Care Unit, MICU Medical Intensive Care Unit, SICU Surgical Intensive Care Unit, CICU Cardiac Intensive Care Unit, ED Emergency Department SBD, n = 36 DBD, n = 59 P value Mean age 53.3 ± ± Males (%) 20 (57) 32 (54) 0.9 Race 0.4 Caucasian (%) 12 (36) 15 (27) African American (%) 19 (58) 35 (62.5) Other (%) 2 (6) 6 (11) Diagnosis <0.001 Ischemic stroke (%) 10 (28) 5 (8.5) Intracerebral hemorrhage (%) 18 (50) 14 (24) Subarachnoid hemorrhage (%) 2 (6) 5 (8.5) Head trauma (%) 5 (14) 13 (22) Cardiac arrest (%) 15 (25) Other (%) 1 (3) 7 (12) Primary neurological diagnosis, n (%) 36 (100) 40 (68) <0.001 Unit where BD occurred NICU, n (%) 29 (81) 16 (27) <0.001 MICU, n (%) 2 (6) 25 (42) SICU, n (%) 4 (11) 15 (25) CICU, n (%) 3 (5) ED, n (%) 1 (3) Service performing the 1st/2nd exam <0.001 NICU 25 (74) 8 (14)/14 (24) Neurology 3 (9) 12 (20.3)/13 (22) Neurosurgery 2 (6) 12 (20.3)/16 (27) MICU 2 (6) 16 (27.1)/10 (17) SICU 2 (6) 10 (17)/4 (7) CICU 1 (2)/2 (3) Service Performing the Final Exam and Informing the Family The NICU service performed the last BD exam in 39 patients (25 as SBD and 14 as second DBD exam) and a non-nicu service in 56 patients. When the NICU service performed the exam, higher Na +, peak Na +, and Cl - levels and a trend for higher SBP measurements were observed, as well as significantly lower BUN, creatinine, and heart rate levels compared to patients examined by non-nicu services (Table 3). Higher completion of the apnea test and more confirmatory tests were also associated with the NICU service. Although we did not find any difference among these services in decoupling, after adjusting for age, race, and type of BD exam, there was a trend toward the NICU service evoking a higher consent rate (P = 0.06). Cost of Performing SBD versus DBD Exam The cost of confirmatory tests in SBD patients, who theoretically should not have required any if they had followed the hospital s older DBD exam policy, was estimated at $33, This was juxtaposed to the cost of 36 patients with SBD exam potentially staying an additional 14.4 h in the ICU waiting for the second exam to be completed, as patients with DBD exam did. This cost was estimated at $77,457.60, which leaves a net benefit of $43, for performing SBD versus DBD exam. Discussion Our study found that SBD exam is equivalent to DBD exam regarding rate of donation, did not lead to any return of brain function and costs less. Except for higher Na + and Cl - levels with SBD exam, the endocrine, renal, and respiratory physiologic variables were no different than those with DBD exam (Tables 1, 2). One-third of patients with DBD exam were on a higher dose of pressors or inotropes at the second exam compared to the first, yet the mean SBP was lower in this group compared to patients with SBD exam. This finding did not translate, however, to a different rate of recovered or transplanted organs. Moreover, we found no evidence to support the hypothesis

5 Neurocrit Care (2011) 15: Table 2 Comparison of patients who underwent single brain death exam to those who underwent dual brain death exams Organ function measures, brain death variables, and donation results SBD single brain death exam, DBD dual brain death exam, DI diabetes insipidus, SBP systolic blood pressure a One patient was excluded from donation, and the family was never approached for consent SBD, n = 36 DBD, n = 59 P value Pressors during 1st exam, n (%) 29 (81) 43 (73) 0.39 : Pressors during 2nd exam, n (%) 18 (35) DI, n (%) 23 (64) 31 (53) 0.27 Treatment of DI offered, n (%) 15 (68) 21 (68) 0.97 Na + at time of death, meq/l ± ± 8.7 <0.001 Hypertonic saline used, n (%) 5 (14) 2 (3) Peak Na + at any time, meq/l ± ± K + at time of death, meq/l 3.8 ± ± Cl - at time of death, meq/l ± ± Bicarbonate at time of death, meq/l 23.3 ± ± BUN at time of death, mg/dl 18.3 ± ± Creatinine at time of death, mg/dl 2.3 ± ± ph at time of death 7.21 ± ± PaCO 2 at time of death, torr 65.8 ± ± PaO 2 at time of death, torr 239 ± ± Heart rate at time of death, beats/min 87.2 ± ± SBP at time of death, mmhg ± ± Apnea test completed, n (%) 32 (89) 48 (83) 0.42 Confirmatory test, n (%) 36 (100) 25 (42.4) <0.001 Decoupling, n (%) 23 (88.5) 34 (87.2) 0.88 Consented donors, n (%) 23 (64) 35 (61) a 0.81 Time admission-1st exam (h) 69.6 ± ± Time between 2 exams (h) 14.4 ± 12.9 Time consent-operating room (h) 31.4 ± ± Time 1st exam-operating room (h) 31.4 ± ± Organs procured, mean ± SD 3.5 ± ± Organs transplanted, mean ± SD 2.9 ± ± Kidneys (1 or 2) transplanted, n (%) 16 (44) 24 (41) 0.72 Lungs (1 or 2) transplanted, n (%) 4 (11) 8 (14) 0.73 Heart transplanted, n (%) 5 (14) 10 (17) 0.69 Liver transplanted, n (%) 19 (53) 21 (36) 0.1 Pancreas transplanted, n (%) 2 (6) 7 (12) 0.31 Intestine transplanted, n (%) 1 (2) Tissue recovered, n (%) 6 (27) 10 (31) 0.75 that SBD has a negative effect on donation, as both decoupling and consent rates were similar. Therefore, our concern that a shorter time for families to accept the demise of their relative after a SBD exam would lead to lower donation rates was unsubstantiated. In fact, in the group with SBD, the time interval from admission to completing the single exam was almost 3 days, comparable to the almost 4 days with DBD and consistent with the AAN Practice Parameters suggestion of waiting several hours from the insult [2]. This interval is not short for a patient with a catastrophic brain injury, as it coincides with the expected peak cerebral edema phase of h. Interestingly, a study just published found the time interval between the two BD exams in nine New York hospitals with >750 beds (like ours) to be 16 h (very close to our mean 14.4 h). Notably, they reported that the consent for organ donation decreased as the interval between the two BD exams increased [6]. In the accompanying Editorial, an interest of having donation results if a single determination were sufficient was mentioned [7]. Our study provides these results and supports our belief that a SBD exam may be as good as or even better than DBD exam regarding consent for donation, if done properly, decoupled and explained to the family in detail [5]. What is the reasoning behind a SBD exam? Unnecessarily prolonging the time from BD to recovering of organs, which sometimes occurs with DBD exams, may adversely affect the transplantation process. The pain and suffering of family members may increase and there may be confusion as to why a second BD exam is required,

6 552 Neurocrit Care (2011) 15: Table 3 Final brain death exam performed by the Neurosciences Intensive Care service compared to other hospital services NICU Neurosciences Intensive Care, DI diabetes insipidus, SBP systolic blood pressure a Adjusted for age, race, and type of BD exam (single or dual BD exam) NICU service, n = 39 Other services, n = 56 P value DI, n (%) 26 (67) 28 (50) 0.1 Treatment of DI offered, n (%) 18 (72) 18 (64) 0.5 Na + at time of death, meq/l ± ± 8.2 <0.001 Hypertonics used before BD, n (%) 4 (11%) 3 (5%) Peak Na + at time of death, meq/l ± ± 8.7 <0.001 K + at time of death, meq/l 3.8 ± ± Cl - at time of death, meq/l ± ± 10.4 <0.001 Bicarbonate at time of death, meq/l 23.4 ± ± BUN at time of death, mg/dl 16.5 ± ± Creatinine at time of death, mg/dl 1.6 ± ± PaO 2 at time of death, torr ± ± Heart rate at time of death, beats/min 83.7 ± ± SBP at time of death, mmhg ± ± Apnea test completed, n (%) 36 (92) 42 (76) Confirmatory test, n (%) 34 (87) 25 (45) <0.001 Consented donors, n (%) 28 (74) 30 (55) 0.11 (0.06) a Organs procured, mean ± SD 3.2 ± ± (0.98) a Organs transplanted, mean ± SD 2.5 ± ± (0.97) a factors that can have a negative impact on the rate of donations [6, 7]. Moreover, the potential donor may become unstable during the period following BD and the number of complications may increase proportionally to the time between declaration of BD and procurement of organs [8, 9]. Progression of BD to cardiac arrest is another immediate risk, with loss of 10 20% of potential donors [6, 8, 9]. Another reason is that there may be worsening of the transplantable organ function as time passes after BD [10]. In our study, we did not find any difference in the organs recovered or transplanted between the groups with shorter (SBD) or longer (DBD) intervals from injury to operating room, except for a trend for more livers transplanted in the former (Table 2). If such a difference in the function of organs to be transplanted had been found, whether positive or negative for SBD, long-term outcomes of these organs should have been included. The reason for reporting those long-term outcomes is that the function of several organs, especially kidneys, which can be suboptimal during the peri-transplantation period, may improve with time. However, the additional time these organs require to reach full functional level adds additional cost compared to fully functional organs immediately after transplantation [11, 12]. This additional cost might have negated any cost benefit for SBD. Finally, SBD exam may simplify the process and decrease the variability in BD determination, which remains significant [13] for such a serious event as the declaration of death, with ethical and medico-legal ramifications [14]. Although our unique SBD exam policy adds to the current variability in BD policies, we believe that it would eventually entail less bedside confusion, if adopted by more hospitals. This simplification of the process would have been a moot point, if SBD exam could allow patients with potential recovery of brain function to be declared BD because of a shortened observation period. We did not find recovery of brain function, however, in any of our SBD or DBD exam patients after the declaration. It is reassuring that any false declaration of BD with SBD exam did not occur during a much longer observation period after SBD (the period between the two DBD exams was more than two times shorter than the period between consent and operating room in patients with SBD exam). Another finding in our study was that the cost of a SBD exam was lower than DBD exams. The additional cost for DBD exam patients was mainly due to the longer period of time they spent in the ICU. Because the confirmatory test was mandatory per SBD exam policy, it also added to its cost. Strong arguments against the use of confirmatory tests have been recently published [15]. If these tests become optional after SBD, the difference in the cost between SBD and DBD may become even more dramatic. In a previous smaller study of patients with head trauma only, a SBD exam was compared favorably to DBD exams regarding hospital charges; however, it is unclear how many patients with DBD exams had confirmatory tests and how much these tests influenced the cost [3]. Our study also suggests that having an expert team performing the BD exams may lead to better donation results. Better renal function, lower heart rate, higher SBP

7 Neurocrit Care (2011) 15: and apnea test completion and a trend for higher consent rates were observed when the NICU team performed the final BD exam and subsequently discussed the BD declaration with families. It is unclear if the strict approach or the greater expertise of the NICU service was the reason, but these data imply that a group of physicians with a greater experience in conducting BD exams [5], probably through a certification process [14], may optimize standardization of BD in the highly variable world of US hospital policies [13]. Our study has some limitations. It is based on the results from a single hospital and may not be applicable for other institutions with a different population mix. Our study is retrospective, which may have introduced biases and weakened the results due to missing data in some of the variables. The number of patients included is small and the study may be underpowered to note meaningful differences in the organ function status with SBD or DBD exams. Because we did not observe any difference in organ function, we did not include long-term organ outcomes after transplantation, which would have been imperative if we had observed otherwise. There were violations of the SBD protocol in 4% of cases and no severity adjustment, which may have initially affected the function of donor organs independently of BD. The measures used to reflect the four organ system functions were crude, but chosen because of the ease of extracting them retrospectively. Confirmatory tests were mandatory in the SBD exam group and added to the cost, but these tests may not be required if skilled physicians or neuroscience specialists [15] perform the clinical exam. Indirect costs to the ICUs or the hospital with DBD, such as additional nursing staff to care for patients or delayed access of critically ill patients to ICU beds, were not estimated. Finally, because SBD exam was performed only in patients with catastrophic brain injuries (i.e., non-survivable injuries), it was deemed a reasonable approach; however, it may not be appropriate for less devastating injuries and a quantitative (instead of our qualitative) definition of catastrophic injury should be devised. A prospective study in several institutions should address many of these limitations and lead to more robust estimates. In conclusion, our study provides evidence that addresses the pivotal issue of SBD in the recently updated Practice Parameters of Brain Death determination [2]. The easier-to-follow SBD exam was not associated with any return of brain activity, led to similar donation rates and equivalent or better organ function status at the time of BD and was conducted at a lower cost. A trend for better donation rates was found when a group of neurointensivists, following a strict family approach protocol, was involved. These results should be reproduced in a large, multicenter, prospective study, evaluating among others the need for a mandatory confirmatory test, before adoption by other hospitals. Acknowledgment The authors would like to thank our statistician, Lonni Schultz, PhD, for her assistance in the statistical analysis of data and Ms Susan MacPhee-Gray for her editorial assistance. The study was supported by Departmental funds. References 1. Uniform Determination of Death Act. 12 Uniform Laws Annotated (U.L.A.), 589 (West 1993 and West Supp 1997) 2. Wijdicks EF, Varelas PN, Gronseth GS, Greer DM. 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