Protocol summary
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Study aim
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Determining the efficacty and safty of Dabigatran, Rivaroxaban and Enoxaparin in the prevention of venous thromboembolism in cancer patients
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Design
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Randomized double blind clinical trial with a control group, with parallel groups, "available or easy" sampling method, Patients divide to three groups by random blocks of size 6. Sample size: 57 people, phase 4
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Settings and conduct
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In this study, patients suffering from cancer, attending to Semnan Kowsar Hospital will be assessed.
Patients are taught; 1) Seenig DVT symptom, go to the hospital and with Doppler Ultrasonography, DVT is confirmed (meter efficacy).
2) Observing abnormal bleeding or erythema: Stop taking the drug and visit an oncologist, and PTT, Activated PTT, and BT tests are taken from patients (meter safety).
Patients are monitored monthly by telephone.
The participant, the main researcher and health personnel who evaluate the outcomes will not be informed about the grouping of patients and the type of medication.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: cancer patients attending Semnan Kosar Hospital (all metastatic patients with either progressive symptoms or in the phase of slowing down the disease).
Non-inclusion criteria: Severe blood pressure (120/180 or more); Moderate or severe hepatic insufficiency; Glomerular filtration rate (GFR) less than 30ml / min; severe bleeding that requires hospitalization; Blood and hemorrhagic diseases
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Intervention groups
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Intervention group1: Enoxaparin at the dose of 40 mg through subcutaneous injection, daily for 3 months.
Intervention group2: Dabigatran at the dose of 150 mg ,orally, daily for 3 months.
Intervention group3: Rivaroxaban at the dose of 10 mg ,orally, daily for 3 months.
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Main outcome variables
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Thromboembolism؛ Bleeding
General information
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Reason for update
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Due to import and purchase restrictions of dabigatran drug, this drug was prepared for only 11 patients. For this reason, a new group was added to the study that receives the drug rivaroxaban.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200407046984N1
Registration date:
2020-07-06, 1399/04/16
Registration timing:
registered_while_recruiting
Last update:
2024-07-23, 1403/05/02
Update count:
1
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Registration date
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2020-07-06, 1399/04/16
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-02-20, 1398/12/01
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Expected recruitment end date
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2021-02-19, 1399/12/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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A comparison of Dabigatran, Enoxaparin and Rivaroxaban for venous thromboembolism prophylaxis in cancer patients
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Public title
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A comparison of Dabigatran, Enoxaparin and Rivaroxaban for venous thromboembolism prophylaxis
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
Cancer patients referred to Kosar Hospital in Semnan (all metastatic patients with either progressive symptoms or in the phase of slowing down the disease)
Exclusion criteria:
High blood pressure (180/120 or more)
Moderate or severe hepatic insufficiency
Glomerular filtration rate (GFR) less than 30ml / min
Severe bleeding (requiring hospitalization)
Blood and hemorrhagic diseases include: hemophilia, Von Willebrand factor deficiency, problems of factors 2, 5, 7,10 and 12, types of Anemia, blood transfusions, Thrombocytopenia, Bernard-Soulier syndrome, Glanzmann, plaque pool storage deficiency syndrome, Vitamin K deficiency, Dysfibrinogenemia, Immune thrombocytopenia purpura (ITP), Acute lymphoblastic leukemia (ALL), Bleeding diathesis
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Age
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No age limit
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Gender
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Both
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Phase
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4
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Groups that have been masked
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- Participant
- Care provider
- Outcome assessor
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Sample size
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Target sample size:
57
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In this double-blind study, patients fall into three groups using available or easy sampling methods. How to assign three groups randomly as 6 blocks using a table of random numbers.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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The participant, the main researcher and health personnel who evaluate the outcomes will not be informed about the grouping of patients and the type of medication.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-11-28, 1398/09/07
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Ethics committee reference number
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IR.SEMUMS.REC.1398.279
Health conditions studied
1
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Description of health condition studied
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Deep vein thromboembolism
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ICD-10 code
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I82.4
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ICD-10 code description
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Acute embolism and thrombosis of deep veins of lower extremity
2
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Description of health condition studied
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Malignant neoplasm of lower respiratory tract
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ICD-10 code
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C39.9
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ICD-10 code description
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Malignant neoplasm of lower respiratory tract, part unspecified
Primary outcomes
1
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Description
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Thromboembolism
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Timepoint
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After seeing the initial symptoms taught to the patient himself
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Method of measurement
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Doppler ultrasound
2
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Description
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Bleeding
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Timepoint
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After seeing the initial symptoms taught to the patient himself
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Method of measurement
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PTT، Activated PTT، BT
Intervention groups
1
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Description
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Control group: There are 35 patients. In this group, subcutaneous injections are given daily for 3 months to prevent DVT Enoxaparin at a dose of 40 mg.
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Category
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Prevention
2
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Description
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Intervention group: There are 11 patients. In this group, to prevent DVT, Dabigatran is given orally at a dose of 150 mg daily for 3 months.
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Category
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Prevention
3
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Description
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Intervention group: There are 11 patients. In this group, to prevent DVT, Rivaroxaban is given orally at a dose of 10 mg daily for 3 months.
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Category
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Prevention
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Semnan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available