Low Molecular Weight hEparin vs. Aspirin Post-partum

Study Overview
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Brief Summary
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This is single centre pilot, randomized controlled trial assessing postpartum prophylactic anticoagulation with 3 weeks of LMWH followed by 3 weeks of Aspirin compared to standard of care of prophylactic LMWH for 6 weeks at moderate to high risk of developing VTE.

Detailed Description
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A single centre pilot, randomized controlled trial assessing postpartum prophylactic anticoagulation with 3 weeks of LMWH followed by 3 weeks of Aspirin compared to standard of care of prophylactic LMWH for 6 weeks for women at moderate to high risk of developing VTE to determine feasibility of conducting a large non inferiority trial using the same regimens.

Official Title
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Low Molecular Weight hEparin vs. Aspirin Post-partum

Conditions
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Venous Thromboembolism

Intervention / Treatment
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* Drug: Prophylactic low molecular weight heparin
* Drug: Low molecular weight heparin and low-dose aspirin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Personal history of unprovoked VTE prior to pregnancy or hormone associated VTE and not prescribed therapeutic anticoagulation or Family history (1st degree relative) of VTE and antithrombin deficiency, protein C or protein S deficiency or Combined thrombophilia or homozygous for the factor V Leiden mutation or prothrombin gene mutation, and family history of VTE (1st degree relative) and > 18 years of age. Exclusion Criteria: Pre-existing indication for therapeutic LMWH Contraindication to ASA: Known ASA allergy Documented history of gastrointestinal ulcer Known platelet count < 50x10^9/L at any time during the current pregnancy or postpartum Contraindication to LMWH, e.g. known allergy Active bleeding at any site, excluding physiological vaginal bleeding Patients with bleeding disorders Known severe hypertension (SBP >200mm/hg and/or DBP >120mm/hg) during the current pregnancy or postpartum

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single Center pilot feasibility RCT
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prophylactic Low Molecular Weight Heparin (LMWH)<br>Prophylactic LMWH for 6 weeks postpartum | Drug: Prophylactic low molecular weight heparin<br>* Enoxaparin 40 mg/dalteparin 5000 U/tinzaparin 4500 U subcutaneously daily for women with weight <100 kg for 6 weeks.<br>* Other names: LMWH;|
| Experimental: Prophylactic Low Molecular Weight Heparin (LMWH) + Low Dose Aspirin<br>Prophylactic LMWH for 3 weeks followed by low dose Aspirin for 3 weeks. | Drug: Low molecular weight heparin and low-dose aspirin<br>* Enoxaparin 40 mg/dalteparin 5000 U/tinzaparin 4500 U subcutaneously daily for women with weight <100 kg for three weeks followed by ASA 81 mg orally daily for three weeks.<br>* Other names: ASA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Enrollment Rate |  | 1 year | 
| Consent Rate |  | 1 year | 
| Adherence to Prescription | Utilization of co-interventions for both: control group (6 week of Low Molecular Weight Heparin) or Treatment group (3 week of low molecular weight Heparin and 3 week of low dose aspirin). | 6 weeks | 
| Withdrawal of consent rate |  | 1 year | 
| Rates of contamination | List of the concurrent medication will be gathered on 3 week follow up, 6 week follow up and early discontinuation (before 6 weeks). | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VTE event rate | VTE must be confirmed either by Doppler ultrasound or V/Q scan or computer tomography (CT). Imaging will not be performed on all patients, only those with symptoms of VTE event. Event rate of VTE will be calculated by number of VTE events by Total days in this study. This number of VTE event is collected during 3 week follow up, 6 week follow up, 3 months follow-up and on early discontinuation date (before 3 months follow up). At the end of the study (after 3 month), the total VTE event rate is calculated. | 3 months | 
| Bleeding assessment six weeks following delivery | According to the International Society on Thrombosis and Hemostasis (ISTH) scoring system. The bleeding assessments are collected on 3 week phone call and 6 week phone call or early discontinuation visit (before 6 week follow up) | 6 weeks | 
| Anticoagulation Satisfaction Assessment using the Duke Anticoagulation Satisfaction Scale (DASS) | The maximum value would be 65, indicating the worst quality of life. Minimum value would be 13, indicating best quality of life. This satisfaction assessment would be collected on dosing (day 1), 3 week follow up, 6 week follow up and if early discontinuation. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postpartum, Prophylaxis, LMWH