Comparison of apixaban and dalteparin for safe thrombosis prophylaxis in bone marrow transplant recipients
Design
Randomized clinical trial for prophylaxis, two parallel intervention groups, not blinded, On 60 patients divided into two 30-individual groups, block randomization using Excel software.
Settings and conduct
This randomized clinical trial is performed in the bone marrow transplant department of Ayatollah Taleghani hospital on two groups of patients consisting of dalteparin and apixaban recipients. After the catheterization, patients receive anticoagulants and their condition is assessed for thrombosis and bleeding during the hospital stay.
Participants/Inclusion and exclusion criteria
Patients ≥ 18 years old, admitted to the bone marrow transplant ward with a khorna score of 2 or higher or a caprini score of 5 or higher, having normal performance, hepatic and renal status
Intervention groups
Intervention group 1: Apixaban 2.5 mg twice daily orally during hospitalization.
Intervention group 2: Administration of dalteparin 5000 units per day by subcutaneous injection during hospitalization.
Anticoagulants administration will be started after the catheterization and be continued until the platelet count drops to less than 50,000 per microliter.
Main outcome variables
Incidence of thrombosis and bleeding
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100127003210N25
Registration date:2022-01-07, 1400/10/17
Registration timing:prospective
Last update:2022-01-07, 1400/10/17
Update count:0
Registration date
2022-01-07, 1400/10/17
Registrant information
Name
Maria Tavakoli Ardakani
Name of organization / entity
Faculty of pharmacy, Shaid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8887 3704
Email address
mariatavakoli@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-21, 1400/11/01
Expected recruitment end date
2023-01-21, 1401/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of apixaban and dalteparin in thromboprophylaxis for hematopoietic stem cells transplant recipients
Public title
Comparison of dalteparin and apixaban in thromboprophylaxis
Purpose
Treatment
Inclusion/Exclusion 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:
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
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization using Excel software
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق دانشکده داروسازی دانشگاه علوم پزشکی شهید بهشتی
Street address
Faculty of Pharmacy, Shahid Beheshti University of Medical Science, Valiasr St., Hashemi Rafsanjani Highway intersection., Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1996835113
Approval date
2021-12-15, 1400/09/24
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1400.242
Health conditions studied
1
Description of health condition studied
Thrombosis in bone marrow transplant patients
ICD-10 code
T86.09
ICD-10 code description
Other complications of bone marrow transplant
Primary outcomes
1
Description
Thrombosis
Timepoint
One month (during hospitalization)
Method of measurement
Color doppler sonography
Secondary outcomes
1
Description
Bleeding
Timepoint
One month (during hospitalization)
Method of measurement
Evaluation of patient laboratory factors; Monitoring the patient for signs of bleeding
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Laboratory findings of patients along with statistical analysis can be shared without providing patients' names.
When the data will become available and for how long
Start 6 months after publication.
To whom data/document is available
Physicians and researchers involved in bone marrow stem cell transplantation Investigations.
Under which criteria data/document could be used
Individuals such as hospital staff or nurses, clinical pharmacists or industry researchers can use the information.
From where data/document is obtainable
Researchers can contact us by email at:
saeed.azimi92.sa@gmail.com
What processes are involved for a request to access data/document
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.