Survey of Massive Blood Loss In the North East of England 2013

Transcription

1 Survey of Massive Blood Loss In the North East of England 2013 November 2014

2 Acknowledgements Dr Michelle Lannon ST6 Haematology The Newcastle upon Tyne Hospitals NHS Foundation Trust Dr Adil Iqbal Consultant Haematologist / Chair of North East RTC County Durham and Darlington NHS Foundation Trust Ms Janice Robertson North East RTC Administrator NHS Blood and Transplant Dr Reuben Saharia Consultant in Emergency Medicine The Newcastle upon Tyne Hospitals NHS Foundation Trust Ms Yvonne Scott Transfusion Manager The Newcastle upon Tyne Hospitals NHS Foundation Trust Dr Hazel Tinegate Consultant Haematologist NHS Blood and Transplant Ms Denise Watson Regional Lead: Patient Blood Management Team NHS Blood and Transplant Special Thanks All of the Transfusion Teams in the region for collecting and submitting the data for this survey. 2

3 Contents Abbreviations Executive Summary Recommendations Introduction Methods Organisational Survey Clinical Survey Discussion References Appendix 1 Organisational Survey Tool Appendix 2 Clinical Survey Tool Page Abbreviations A&E Accident and Emergency APTT Activated Partial Thromboplastin Time CDDFT County Durham and Darlington Foundation Trust CMV Cytomegalovirus Cryo Cryoprecipitate FFP Fresh Frozen Plasma GI Gastro Intestinal HALT-IT Haemorrhage alleviation with tranexamic acid Intestinal system MH Massive Haemorrhage O RhD -ve Group O Rhesus D negative O RhD +ve Group O Rhesus D positive NHS National Health Service NPSA National Patient Safety Agency PCC Prothrombin Complex Concentrate PT Prothrombin Time RBC Red Blood Cells RRR Rapid Response Report SABRE Serious Adverse Blood Reactions and Events SHOT Serious Hazards of Transfusion TXA Tranexamic Acid XM Cross Matched 3

4 Executive summary Introduction All NHS Trusts in the North East Region (8 Trusts, 14 sites) undertook a survey of the management of massive blood loss. The survey consisted of an organisational questionnaire, and also data collection for individual episodes of major haemorrhage over a three month period in Aims To review transfusion policies for massive haemorrhage within the region, in terms of clinical, laboratory and logistic responses, and to review cases to gain a regional understanding of patterns of presentation, management, blood component use and investigations. Methodology The survey comprised an organisational questionnaire about laboratory and clinical transfusion practice in the event of a major haemorrhage, and a survey of individual cases of major haemorrhage presenting during the study period. Data were entered onto a web-based survey tool and then collated on a spreadsheet. No patientidentifiable data were collected, but each hospital transfusion team was asked to ensure the survey met governance arrangements within their Trust. Key findings: organisational survey All of the eight Trusts within the Region participated. All had massive haemorrhage protocols covering actions within emergency departments, surgery and gastroenterology. In one Trust, the policy did not cover major obstetric haemorrhage. For all Trusts, clinical staff could activate the protocol and in two, laboratory staff could also do so. Four Trusts had a specific telephone number and seven had a specific activation code. Three stated they would identify a specific person to handle contacts during the major haemorrhage alert. Only two sites carried out regular major haemorrhage drills, with a further Trust reporting occasional drills. All Trusts allow release of blood components without the approval of a consultant haematologist. Six Trusts used major haemorrhage packs, details of which are given in Table 1. There was variation in the contents of these packs. No Trusts reported having pre-thawed FFP available, although one very large site has implemented this since. Four of the Trusts reported keeping on-site platelets. Trusts varied in their readiness to use group O RhD negative blood in the first instance. All but one Trust advocated the use of tranexamic acid in major haemorrhage. Key findings: major haemorrhage cases There were 81 cases of major haemorrhage during the study period. Although all 14 sites were collecting data, major haemorrhage cases presented in only 8 of the 14 sites. 48 cases (59%) presented to the two largest Trusts in the region (Figure 1). Major haemorrhage protocols were activated for 55 of these 81 cases. 69% of major haemorrhages were in patients admitted as an emergency. Major haemorrhages presented around the clock with 54 cases in core hours 08:00-19:59 hours, 17 between 20:00 and 23:59 hours and 10 between midnight and 07:59 hours. For the 55 cases where protocols were activated, this was most commonly declared by emergency departments (30 cases, 55%), followed by anaesthetic departments (11 cases, 20%) and obstetrics (6 cases, 11%). The commonest clinical scenarios were upper GI bleeding (17 cases), blunt trauma (11 cases), vascular surgery (11 cases) and obstetrics (9 cases). 80/81 patients received red cells, in many cases a combination of crossmatched, group specific and either O RhD negative or positive red cells. 71 patients received fresh frozen plasma (with 4

5 another 2 having FFP issued but not used) and 52 patients received platelets (with another 7 having platelets issued but not used). 27 patients received cryoprecipitate (with another 5 having cryoprecipitate issued but not used). In addition, 4 patients were given Factor VIIa and 6 patients prothrombin complex concentrates. None received fibrinogen concentrate. Figures 4 and 5 show the range and timing of blood component use. Not all components issued were transfused. Figure 2 shows the fate of components where the outcome can be confirmed. All trauma cases were given tranexamic acid. Recommendations All sites should have a protocol that enables the release of blood components without the initial approval of a haematologist, although they should be advised of the situation at the earliest opportunity (NPSA/2010/RRR017) All sites within the region should have a uniform approach to numbers of red cells and FFP units, at least in the first major haemorrhage pack Smaller sites that report keeping stock platelets should monitor wastage rates All sites, especially those where MH is rare, should perform drills at least once a year The region should continue to use TXA in MH associated with trauma This exercise should be repeated, as an audit, using NPSA/2010/RRR017 and recommendations from CRASH-2 as standards. Any recommendations from the HALT-IT trial should also be incorporated Major haemorrhage protocols should include specific actions for off-site laboratories. 5

6 Introduction Massive blood loss can impact on the survival of patients in many clinical settings. The National Patient Safety Agency (transferred to the NHS Commissioning Board Special Health Authority) recognises that the early recognition of major blood loss and immediate effective interventions including the rapid provision of blood and blood components are vital to avoid detrimental consequences. Following a review of incidents reported to them over a 4 year period the NPSA highlighted that there had been 11 deaths and 83 incidents of patient harm as a result of delays in the provision of blood in an acute situation. In 2010 they released a rapid response report (NPSA/2010/RRR017) mandating requirements for Trusts in relation to the transfusion of blood and blood components in an emergency. 1 Evidence from SHOT and audit results from across the country demonstrate that compliance with these NPSA requirements relating particularly to the presence of massive haemorrhage protocols, protocol activation and following protocol procedure is suboptimal. In 2011, the CRASH-2 trial identified that tranexamic acid significantly reduced all-cause mortality, in trauma patients with significant haemorrhage, if given within 3 hours of injury. 2 The requirement to translate these findings into clinical practice has been endorsed by the Department of Health. It was agreed that the North East region would undertake a regional survey of the management of massive haemorrhage events with a parallel organisational survey to gain information about the local management of massive haemorrhage. Methods A consensus approach was adopted to conduct the survey. The regional transfusion committee/practitioners elected to undertake the data collection online from each site. To facilitate this, online surveys were constructed using SurveyMonkey to collect information regarding specific massive haemorrhage events and organisational data relevant to each Trust who took part in the survey. Both data collection tools are given as appendices 1 and 2. Appropriate governance arrangements were implemented and approval from individual Hospital Transfusion Committee chair s to participate in the survey was obtained. Each site that elected to participate in the survey was asked to collect information on each massive haemorrhage event. One organisational survey was collected for each participating Trust. A pragmatic time frame was adopted which was later extended. Data collection was undertaken by local transfusion practitioners and took place in July to September Data were downloaded as an Excel spreadsheet and analysed proportionately (n, %). No patient identifying data were used. Participating sites have been named for ease of data interpretation. 6

7 Organisational Survey Results 8/8 (100%) NHS Hospital Trusts responded to the organisational survey. This survey collected information regarding local policies and practices in place at participating sites. Definitions and Guidelines For the purpose of this survey, the definition of major haemorrhage was transfusion of more than 8 units of red cells in a 24 hour period, or on activation of the major haemorrhage protocol. All participating organisations had protocols and guidelines in place, and all stated these were regularly reviewed. Protocol Contents All eight Trusts have protocols for the requesting of emergency blood, actions by laboratory and clinical teams, and all stated they had a nominated person for contacting the laboratory. For six Trusts, the protocol covered support staff, similar to an audit in Yorkshire and The Humber. 3 Only one site commented that the protocol covered actions by off-site laboratories, in contrast to Yorkshire and The Humber (6/19). Specialities Covered All protocols covered the areas of Accident and Emergency, Surgery and Gastroenterology. There was some variation in protocol content for other specialities which could reflect organisational structures and hospital type. Three Trusts omitted paediatrics and cardiac surgery from their protocols, probably due to case mix, and two Trusts omitted vascular surgery, probably for the same reason. However, orthopaedic, obstetric and gynaecology services are omitted from one protocol respectively. Protocol Activation All Trusts reported that the protocol could be activated by clinical staff. Two reported that laboratory staff could trigger it. This is similar to Yorkshire and The Humber. Four Trusts reported they had a specific telephone number for notification, and seven used a specific activation code. In one Trust, a specific trauma bleep is used. A further two Trusts communicated the location and the patients details to the laboratory. Five Trusts stated the haematologist was usually called for a MH but all stated that blood could be issued without haematologist approval. Monitoring, Audit and Drills A range of staff including laboratory staff, transfusion practitioners, anaesthetists, consultant haematologists, surgeons and emergency medicine consultants were reported to monitor the protocol, in addition to the hospital transfusion committees and teams. Only two Trusts reported that they ran regular drills, but four reported that they audited the protocol. Specific Contents of the Major Haemorrhage Pack Six Trusts used major haemorrhage packs. Five provided information about contents as described in Table 1. FFP No Trusts reported using pre-thawed FFP, although, since the survey, we are aware of at least one Trust, with two sites, that now does include this in the MH pack. 7

8 Platelets Four Trusts had platelets available. Two large Trusts which were major trauma centres held stocks of 5 and 3 platelets respectively. One small user stated that 4-6 adult platelet units were available (hopefully used for planned transfusions) whilst one stated it held a platelet preferably AB negative, irradiated, CMV negative. Group O red cells Seven sites stated their policy covered the use of group O blood where the patient s group was not known, and six of these indicated the use of group O RhD negative red cells in this circumstance in women of childbearing potential. Since this survey was carried out, guidelines on pre-transfusion compatibility procedures, which advise that group O blood should be used until the patient s group has been established by a second sample, have been issued. Table 1 Trust Pack 1 Pack 2 Pack 3 Component RBCs FFP Platelets Cryoprecipitate Other RBCs FFP Platelets Cryoprecipitate Other RBCs FFP Platelets Cryoprecipitate Other South Tyneside North Tees and Hartlepool South Tees Newcastle Sunderland Gateshead Northumbria CDDFT np np np np np np np np np np np np np np np ir ir ir np np np np np np np np np np np np np np np nd nd nd nd nd nd nd nd nd nd nd nd nd nd nd np = No Pack Used, nd = pack used but no data, ir = if requested One Trust who did not submit case data said they issued a shock pack on demand but did not indicate the contents. All eight Trusts that had protocols advocated use of tranexamic acid. Summary Box 1 100% of organisational questionnaires submitted Variation in major haemorrhage pack contents particularly use of platelets 2/8 undertake drills 4 sites have a dedicated telephone number to activate the major haemorrhage protocol 8

9 Clinical Survey Demographics 81 individual case data were submitted by hospital transfusion staff. 8 of 14 sites contributed case data (Figure 1). Five other sites had no cases of major haemorrhage, and another site had two cases but was unable to submit the data. The mean age of patients was 52 years (age range 15-90) with 52 (64%) males and 29 (36%) females. Only two cases were under 18 years of age, one 15 year old and one 17 year old. The identity of the patient was known in 72 cases (88%), gender in 75 (91%), age in 64 (79%) and for females, whether under age 50 (i.e. of childbearing potential) in 21/29 cases (72%). Fifty-six cases (69%) were emergency admissions and 25 (31%) elective. Fifty-four cases presented in core hours (08:00 to 19:59), 17 in the evening (20:00 to 23:59) and 10 at night (midnight to 07:59). Number of Cases Submitted Figure 1 indicates the number of individual massive haemorrhage cases submitted by each Trust. Figure 1 Cases submitted Cases Submitted Newcastle South Tees CDDFT Sunderland North Tees and Hartlepool Gateshead Northumbria South Tyneside Number of cases Trust Where was the haemorrhage initially managed? Not all cases later considered to be major haemorrhage were associated with protocol activation. Table 2 shows the location of major haemorrhage and whether the major haemorrhage protocol was activated. Table 2 Location of MH activation Location Number of Cases Number of Cases Where Protocol Activated A&E (71%) Theatre (68%) Labour Ward 6 6 (100%) Medical Ward 4 1 (25%) Critical Care 4 1 (25%) Other* 2 1 (50%) Surgical Ward 1 1 (100%) Obstetric Theatre 1 1 (100%) Total (68%) * = 1 case Transplant Ward, 1 case = Emergency Assessment In 6 cases (5 from one Trust), information about protocol activation was unavailable. 9

10 Protocol activation The major haemorrhage protocol was activated in 55 cases. All but three of these were reported to be appropriate activations. 28 (51%) were initiated by a consultant, 13 by middle grade or specialty doctors, two by midwives and two by laboratory staff. Information was not available on the other 10 episodes. The speciality activating the protocol is given in Table 3 and the cause in Table 4. Table 3 Activating Speciality Speciality Number of Cases* Emergency Department 30 (55%) Anaesthetics 11 (20%) Obstetrics 6 (11%) Gynaecology 1 (2%) Critical Care 1 (2%) Medicine 1 (2%) Surgery 2 (4%) Transplant 1 (2%) Other 2** (4%) * denominator = number of activated cases (55) **1= unknown, 1 = automatic, part of rolling programme Table 4 Cause of Major Haemorrhage Cause Number of Cases Upper GI bleed 17 Trauma blunt 11 Vascular 11 Intraoperative - Obstetrics 9 Cardiac 5 Gynaecology 5 Intraoperative - Other 5 Lower GI 4 Trauma blunt and penetrating 4 Transplant 3 Trauma - Penetrating 2 Other 5 The 5 remaining as Other included a head injury, a collapse, and an intracranial bleed. One was described as liver with the last case indicated as unclear. Table 5 Component Use Data on use of components by patients was calculated from figures entered into the survey. Patients may have received a mixture of Group O and group specific red cells. One patient did not receive any components, for whatever clinical reason. 10

11 Component Number of Patients Emergency O RhD - ve 28 Emergency O RhD +ve 8 Group Specific RBCs 29 Cross Matched RBCs 54 Platelets 52 Cryoprecipitate Pools 27 Fresh Frozen Plasma 71 Factor VIIa 4 PCC 6 Fibrinogen 0 Figure 2 Fate of components The majority of components were used. A total of 138 out of 2270 were discarded (6.1%). For platelets especially, the final fate was not recorded in 93/260 units (35.8%) O neg RBC O pos RBC Grouped RBC X-M RBC FFP Platelets Cryo Used Returned Discarded unknown 11

12 Figure 3 Use of Platelets Number of episodes of major haemorrhage Number of doses given Number of platelet doses Times to Component Use Case data were also collected on the time taken for each phase of blood component deployment. Figure 4 indicates the time taken from laboratory contact to issue of the components and Figure 5 indicates the time taken from laboratory contact to administration in terms of the number of each component given in each time slot (e.g. 18 patients received O RhD negative red cells between 0-15 minutes). Unfortunately, no data were given for 17 platelets, 12 cryo, 15 FFP, or 8 crossmatched, 12 group-specific, 4 emergency O RhD positive and 3 emergency O RhD negative red cell units. The majority of red cells were issued within 15 minutes from first contact, including group specific units (96% of O RhD negative units, 41% O RhD positive units and 43% of electronic issue units). Platelet issues were variable throughout the resuscitations with 14/57 (25%) of the cases having platelets issued in the first 15 minutes and 15/57 (26%) of the cases having platelets issued more than 2 hours from first contact. This is presumably dependent on the presence of stock platelets. In the cases where FFP was issued, the majority of the issues were made within the first 30 minutes from first contact 22/73 (30%) at 0-15 minutes and 17/73 (23%) at minutes. In comparison, the majority of the cryoprecipitate issues occurred later in the resuscitation process with 14/32 (44%) of cases having it issued more than 2 hours from first contact and otherwise a small number of cases received cryoprecipitate between 0-15 minutes and 2 hours. 5/6 (83%) of cases where PCCs were used it was issued within 30 minutes of first contact and in the 4 cases where Factor VIIa was used it was issued more than 2 hours from first contact. 12

13 Comparison of Figures 4 and 5 shows that there were no major differences in the pattern of component use from issue to transfusion. Fi g ure 4 T i m e f rom l a b or a t or y c on t a c t t o i s s u e of c o m p on e n ts 3 0 Number of patients > N K T i m e s i nc e s ta rt, m i n ut e s O n e g R B C 2 8 pa t i e n t s ) O p o s R B C ( 8 ) G ro up R B C ( 2 9 ) X M R B C ( 5 4 ) P l t ( 5 7 ) F FP C ry o ( 3 2 ) F ig u r e 5 Ti m e f r om l a b or a to r y c o nt a c t t o tr a ns fu s i on o f c o m po n e n ts Number of patients T i m e s i n c e s ta rt, m i n u te s > 1 20 O n e g R B C O p o s R B C G ro u p R B C X M RB C P l t F F P Cr y o Thromboelastography was used in 5 cases of haemorrhage management. Intraoperative cell salvage was used in 15 cases (5 cases in Cardiac theatres, 3 in Vascular theatres, 2 in Obstetric theatres, 1 case in Urology theatres, 1 trauma case, 1 during a liver transplant and 2 intraoperatively but not specified). Volume re-infusion information was given in 7 of these cases. The mean volume re-infused was 1577mls ( mls). Haemostatic agents Tranexamic Acid was used in 25 cases and in all (15) trauma cases. There was one case where tranexamic acid was given outside 3 hours. Information on dosage was given in 23 of these cases. Twenty received 1gm doses and two 500mgs. One case received 2gms. Second doses of tranexamic were given on 6 occasions. 5 received a 1gm dose and one patient 500mg. Prothrombin complex concentrate was used in six cases, five within 30 minutes. 13

14 Factor VIIa was used in four cases and in all these cases it was used more than two hours after first contact. Summary Box 2 Upper GI bleeds, blunt trauma and vascular surgical cases were the commonest categories for major haemorrhage 69% were emergency presentations All but one case received red cells, 88% received FFP, 64% cryoprecipitate, 62% platelets Discard of unused units was low for all components with the exception of FFP (89 of the unused units were discarded) The fate of 36% of platelets was unknown The majority of red cells were issued within 15 minutes and administered within 30 minutes of first contact Platelet issues were variable with (25%) of the cases having platelets issued in the first 15 minutes and (26%) of the cases having platelets issued and administered more than 2 hours from first contact The majority of FFP units were issued within the first 30 minutes from first contact but in contrast the majority of the cryoprecipitate issues occurred more than 2 hours from first contact Cell salvage was used in 15 cases, 1 case being trauma Tranexamic acid was used in 25 cases and in all (15) trauma cases but the dose used varied. A second dose of tranexamic acid was only given in 6 (24%) cases 7/8 organisations submitted clinical case data Protocol activated in 68% of cases Laboratory Parameters Prior to transfusion, where figures were given, 34% of patients had a haemoglobin <80g/L, 31% had platelets <150 x 10 9 /L, 26% a PT >18 seconds, 18% an APTT >45 seconds and 17% a fibrinogen <2g/L. Following transfusion, the majority of parameters improved. However, whilst the pre-transfusion platelet count was below 150 x 10 9 /L in 31% of cases, post-transfusion the figure rose to 71%. Other Information Blue light deliveries were required for 3 cases of red cell use and 9 cases of platelet use The laboratory was informed of de-activation of the protocol in 29/55 (53%) of cases but not informed in 5/55 (9%) cases. Not known was returned in 21/55 (38%) of cases. One case was reported as part of a major incident for the Trust (reason not known) and two cases were reported to SHOT/SABRE (one handling and storage error and one acute transfusion reaction). In 44/81 (54%) there was documentation of information given to the patient. In two cases it was stated the patient was not informed, one as the patient remained unconscious and the other for an unknown reason. The mortality rate for the patients included in this dataset was 14/81 (17%). Discussion In addition to the points made in the executive summary: This was performed as a survey rather than an audit, to determine whether it was feasible to have a region-wide major haemorrhage policy. The variability of the contents of the major haemorrhage packs between sites suggests this would be helpful. However, the two sites that manage 60% of major haemorrhages are both major trauma centres, and have a case mix that facilitates keeping a stock platelet which can be reissued to another patient if not used. Similarly, the largest site can 14

15 be confident that pre-thawed FFP can be used by another patient if unused in the MH packs. Site size, and remote location, may influence the pack contents. The major areas for concern are that not all sites have major drills and that two Trusts (3 sites) do not have a specified MH pack. Another Trust with 2 sites provided no data. Consideration should be given to developing a regional policy covering all sites where a major haemorrhage might occur. The smaller sites, with very rare MHs, should consider holding one drill at least once a year. References 1. National Patient Safety Agency (2010) The transfusion of blood and blood components in an emergency, NPSA/2010/RRR017 (last accessed ) 2. Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2); a randomised, placebo-controlled trial (2010), Lancet; 376: Yorkshire and The Humber Regional Transfusion Committee (2013) Massive Haemorrhage audit (last accessed ) 4. Milkins C, Berryman J, Cantwell C, Elliot C et al (2013) Guidelines for pre-transfusion compatibility procedures in blood transfusion laboratories Trans Med 23, 3-35 Appendices 1. Organisational Survey Tool Organisational tool.pdf 2. Clinical Survey Tool Clinical Survey Tool.pdf 15