ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI CLINICAL RESEARCH CENTER ALDO E FOR CELE RARE DACCO DISEASES ALDO E CELE DACCO
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1 ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI CENTRO MARIO DI NEGRI RICERCHE INSTITUTE CLINICHE FOR PHARMACOLOGICAL PER LE MALATTIE RESEARCH RARE CLINICAL RESEARCH CENTER ALDO E FOR CELE RARE DACCO DISEASES ALDO E CELE DACCO International Registry of Recurrent and Familial HUS/TTP FILE. VISIT. Referring physician: Personal data surname name hospital address telephone number fax number Patient data: surname name sex birth date birth place country telephone number address Gruppo sanguigno Rh (+/-) Codice fiscale (for Italian resident only) Tessera sanitaria (for Italian resident only) History of : HUS TTP both HUS and TTP First episode date of onset: ongoing: yes no date of remission: Last episode date of onset: ongoing: yes no date of remission: total number of episodes: ongoing - 1 -
2 FILE. VISIT. Clinical data collection (informations regarding the last episode) Predisposing conditions: - family history of HUS/TTP - if yes, please specify the affected relatives and the disease - hypocomplementemia - family history of hypocomplementemia - if yes, please specify the affected relatives - pregnancy - birth control pill - drugs - cyclosporin - mitomycin C - antiphospholipid syndrome - notes - systemic disease - if please specify - malignant hypertension - transplant - cancer Triggering agents: - verotoxin producing E. Coli - other gastrointestinal infection - viral infection Prodromes: if please specify - date of onset - diarrhea - bloody - vomiting - abdominal pain - upper respiratory tract infections - fever - 2 -
3 FILE. VISIT. Clinical data collection - continue- (informations regarding the last episode) Clinical manifestations: - purpura - jaundice - anuria if please specify how many days - need for dialysis if please specify how many days - neurological signs if please specify: - coma - convulsions Complications: - severe hypertension - sepsis if please specify - bleeding if please specify - neurological sequelae if please specify - 3 -
4 FILE. VISIT. Treatment: Clinical data collection - continue- (informations regarding the last episode) if please specify commercial nomination of the drug, dose, route and way of administration, duration antibiotics antimotility agents antihypertensive agents antiplatelet agents anticoagulants thrombolytic agents antioxidants steroids vincristine immunoglobulins whole blood transfusion packed cell transfusion plasma infusion plasma exchange plasma cryosupernatant rituximab eculizumab other need for splenectomy note - 4 -
5 FILE. VISIT. Stool colture (informations regarding the last episode) Done If Done, please specify Not done Unknown - 1 st sample - 2 nd sample Negative Positive for - 3 rd sample Negative Positive for Negative Positive for Note: Detection of Shiga-toxin in stools Done Not done Unknown Result Notes: Serum antibodies to Shiga-toxin Done Not done Unknown Result Note: Serum antibodies to E-Coli 0157 lipopolysaccharides (LPS) Done Not done Unknown Result Note: Other specific determinations - 5 -
6 a International Registry of Recurrent and Familial HUS/TTP FILE. VISIT. date:... date:... date:... blood pressure mm Hg hematology hemoglobin g/dl hematocrit RBC MCV MCH MCHC WBC N L M Main clinical and laboratory data at hospital admission and discharge (regarding the last episode) (if Not Available, please complete with N.A., if Not Done, please complete with N.D.) hospital admission hospital discharge last follow-up E B platelet count 10 6 /cc µ 3 pc g/dl 10 3 /cc 10 6 /cc reticolocytes fragmented erythrocytes hemoglobin electrophoresis Hb A2 fetal Hb globular osmotic resistance serum haptoglobin biochemistry , , alfa alfa beta 8-15 gamma ALT IU/L 0-46 CPK IU/L M: ; F: LDH IU/L gamma GT IU/L 6-50 alkaline phosphatase IU/L Na meq/l K meq/l Ca P notes: abnormal Hb absent albumin g/dl monoclonal component glycemia measure unit total protein g/dl 6-8 absent urea creatinine uric acid cholesterol triglyceride total bilirubin direct bilirubin AST IU/L normal range <
7 RECURRENT HEMOLYTIC International UREMIC Registry SYNDROME of Recurrent - THROMBOTIC and Familial THROMBOCYTOPENIC HUS/TTP PURPURA FILE. VISIT. notes: Main clinical and laboratory data at hospital admission and discharge (regarding the last episode) (if Not Available, please complete with N.A., if Not Done, please complete with N.D.) measure hospital admission hospital discharge last follow-up unit date: date: date: normal range clotting & hemostasis prothrombin time partial thromboplastin time thrombin time fibrinogen lupus anticoagulant acid-base balance ph (venous) PO2 PCO2 BE SB BA immunology C 3 C 4 IgA IgM IgG RA test W. ROOSE LE phenomenon ANA ANTI DNA ANCA sedimentation rate 1h antistreptolysine title PCR anticardiolipine Ab urine specific weight ph hemoglobin glucose ketones protein sediment INR Ratio Ratio mlhg mlhg meq/l meq/l meq/l UI/ml mm/h GPL RBC WBC other urea mg/24h Na K meq/24h meq/24h creatinine clearance ml/min urineculture negative urinary protein g/24h urinary protein electrophoresis < V: ; A: V: 41-51; A: ± V: 24-28; A: :40 negative; 1:320 positive 1:10 negative; 1:80 positive absent negative 0-7 M: 0-15; F: 0-20; <1:128 negativo ,015-1, absent 0-10 <200 absent
8 FILE. VISIT. Clinical data collection on outcome Yes No Peritoneal Dialysis start at (date) Hemodialysis start at (date) Renal Transplant date Treatment Transplant failure Yes No Reasons for transplant failure date of return to chronic dialysis other renal transplant Yes No date Note Liver/Kidney transplant Yes No date Treatment Data at last follow-up date Note - 8 -
9 FILE. VISIT. BIOLOGICAL SAMPLES COLLECTED FOR COORDINATING CENTER: Please, specify DATE of COLLECTION: / / DATE of EXPEDITION: / / Patients treatment at the time of collection: of last treatment with: - steroids / / - immunoglobulins / / - whole blood transfusion / / - packed cell transfusion / / Laboratory tests at the time of collection: - Hemoglobin g/dl - Hematocrit - WBC 10 3 /cc - Platelet count 10 6 /cc - plasma infusion / / - Serum creatinine - plasma exchange / / - plasma cryosupernatant / / - Serum haptoglobin - LDH IU/L - rituximab / / - C 3 - eculizumab / / - C 4-9 -
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