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IRCT20100127003210N25 IRCT 2022-01-07 Shahid Beheshti University of Medical Sciences Comparison of dalteparin and apixaban in thromboprophylaxis Comparison of apixaban and dalteparin in thromboprophylaxis for hematopoietic stem cells transplant recipients 2022-01-21 anticipated 60 Complete https://irct.ir/trial/56310 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization using Excel software. 2 Thrombosis in bone marrow transplant patients. 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, starting after catheterization. Yes - There is a plan to make this available What will be shared: Laboratory findings of patients along with statistical analysis can be shared without providing patients' names. When: Start 6 months after publication. To whom: Physicians and researchers involved in bone marrow stem cell transplantation Investigations. Conditions: Individuals such as hospital staff or nurses, clinical pharmacists or industry researchers can use the information. Where to obtain: Researchers can contact us by email at: saeed.azimi92.sa@gmail.com How to obtain: Submitting an official application from the relevant authorities. Individuals who intend to use the information must be affiliated with reputable organizations and submit their application through these organizations. Comments:
public Maria Tavakoli Ardakani
Tehran, Niayesh - Valiasr intersection, Niayesh educational complex, Shahid Beheshti faculty of pharmacy
Tehran Iran (Islamic Republic of) 1469658843 +98 21 8887 3704 mariatavakoli@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Maria Tavakoli Ardakani
Tehran, Niayesh - Valiasr intersection, Niayesh educational complex, Shahid Beheshti faculty of pharmacy
Tehran Iran (Islamic Republic of) 1469658843 +98 21 8887 3704 mariatavakoli@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) 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 18 years no limit Both 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 T86.09 Other complications of bone marrow transplant Treatment - Drugs Treatment - Drugs Intervention group: Apixaban 2.5 mg twice daily orally, starting after catheterization Intervention group: Dalteparin, 5000 units daily as subcutaneous injection, starting after catheterization Thrombosis. Timepoint: One month (during hospitalization). Method of measurement: Color doppler sonography. Bleeding. Timepoint: One month (during hospitalization). Method of measurement: Evaluation of patient laboratory factors; Monitoring the patient for signs of bleeding. Shahid Beheshti University of Medical Sciences Approved 2021-12-15 کمیته اخلاق دانشکده داروسازی دانشگاه علوم پزشکی شهید بهشتی Faculty of Pharmacy, Shahid Beheshti University of Medical Science, Valiasr St., Hashemi Rafsanjani Highway intersection., Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)