Low Molecular Weight hEparin vs. Aspirin Post-partum

Mount Sinai Hospital, Canada30 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Venous Thromboembolism

Interventions

Prophylactic low molecular weight heparinDRUG

Enoxaparin 40 mg/dalteparin 5000 U/tinzaparin 4500 U subcutaneously daily for women with weight \<100 kg for 6 weeks.

Low molecular weight heparin and low-dose aspirinDRUG

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Personal history of unprovoked VTE prior to pregnancy or hormone associated VTE and not prescribed therapeutic anticoagulation or 2. Family history (1st degree relative) of VTE and antithrombin deficiency, protein C or protein S deficiency or 3. Combined thrombophilia or homozygous for the factor V Leiden mutation or prothrombin gene mutation, and family history of VTE (1st degree relative) and 4. \> 18 years of age. Exclusion Criteria: 1. Pre-existing indication for therapeutic LMWH 2. Contraindication to ASA: 1. Known ASA allergy 2. Documented history of gastrointestinal ulcer 3. Known platelet count \< 50x10\^9/L at any time during the current pregnancy or postpartum 3. Contraindication to LMWH, e.g. known allergy 4. Active bleeding at any site, excluding physiological vaginal bleeding 5. Patients with bleeding disorders 6. Known severe hypertension (SBP \>200mm/hg and/or DBP \>120mm/hg) during the current pregnancy or postpartum

Locations (1)

Mount Sinai Hospital

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

Enrollment Rate

Time frame: 1 year

Consent Rate

Time frame: 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).

Time frame: 6 weeks

Withdrawal of consent rate

Time frame: 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).

Time frame: 6 weeks

Secondary Outcomes

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.

Time frame: 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)

Time frame: 6 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.