Thrombosis in bone marrow transplant patients. Other complications of bone marrow transplant
Conditions
Interventions
Intervention 1: Intervention group: Apixaban 2.5 mg twice daily orally, starting after catheterization. Intervention 2: Intervention group: Dalteparin, 5000 units daily as subcutaneous injection, star
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients aged = 18 years, candidates for bone marrow stem cell transplantation Weight = 40 kg Khorona score = 2 or caprini score = 5 Life expectancy longer than 60 days and performance status score = 2 according to ECOG criteria Creatinine clearance = 30 mL / min Platelet count = 50000 / µL Liver function test (AST, ALT) below three times the upper limit normal INR = 1.6 No pregnancy
Exclusion criteria
Exclusion criteria: Bacterial endocarditis Active bleeding, uncontrolled hypertension (SBP> 170, DBP> 110) Patients receiving haploidentical allogenic transplantation consuming cyclophosphamide Active bleeding in seven days or more before randomization Severe liver disease (known as Childs Pugh cirrhosis class B or C) or kidney disease (creatinine clearance less than 30 ml / min) Known anticoagulation disorder Thrombocytopenia due to previous heparin use
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Thrombosis. Timepoint: One month (during hospitalization). Method of measurement: Color doppler sonography. | — |
Secondary
| Measure | Time frame |
|---|---|
| Bleeding. Timepoint: One month (during hospitalization). Method of measurement: Evaluation of patient laboratory factors; Monitoring the patient for signs of bleeding. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMaria Tavakoli Ardakani
Shahid Beheshti University of Medical Sciences
Outcome results
None listed