A Pilot Study Assessing the Feasibility of a Randomized Controlled Trial Evaluating Aspirin in Postpartum Women at Risk of Developing Venous Thromboembolism
Overview
- Phase
- Early Phase 1
- Intervention
- Aspirin 81 mg
- Conditions
- Venous Thromboembolism
- Sponsor
- University of Calgary
- Enrollment
- 257
- Locations
- 7
- Primary Endpoint
- Recruitment Rate
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The pilot PARTUM trial is a randomized, multicenter, placebo-controlled trial. Women who are at modest risk of VTE (as defined by the inclusion criteria) will be identified during pregnancy, labor and delivery and up to 48 hours postpartum. Eligible and consenting participants will be randomly assigned to one of two study arms: aspirin 81 mg daily or placebo daily for 6 weeks.
Detailed Description
The purpose of the pilot PARTUM trial is to determine whether it is feasible to conduct a larger randomized controlled trial to determine whether low-dose aspirin is efficacious and safe at preventing postpartum venous thromboembolism (VTE) in women at increased risk of VTE, compared to placebo. Given the large sample size needed to adequately power a large multicenter trial that assesses the efficacy of aspirin 81 mg versus placebo, the investigators first need to determine if it is possible to recruit enough women. If the pilot trial is successful and there are no major changes to the study design, then the secondary clinical outcomes collected in the pilot trial will be used in the analysis of the full multicenter trial.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Study inclusion criteria includes one (or more) first order criterion or two (or more) second order criteria. A patient is still eligible if they have multiple criteria met, at the discretion of the local investigator.
- •ONE (or more) First Order Criteria:
- •Known inherited thrombophilia diagnosed prior to enrolment:
- •i) Heterozygous factor V Leiden, OR ii) Heterozygous prothrombin gene variant, OR iii) Protein C deficiency, OR iv) Protein S deficiency
- •Immobilization (90% of waking hours spent in bed) for ≥7 days anytime during the antepartum period
- •TWO (or more) Second Order Criteria:
- •Postpartum infection
- •Postpartum hemorrhage (\>1000 mL of blood loss, regardless of delivery mode)
- •Pre-pregnancy BMI ≥30 kg/m2
- •Emergency or unplanned cesarean delivery
Exclusion Criteria
- •More than 48 hours since delivery
- •Received more than 2 doses of low-molecular-weight heparin (LMWH) since delivery
- •Need for postpartum LMWH prophylaxis or systemic anticoagulation as judged by the local investigator. May include but is not limited to:
- •Documented history of provoked or unprovoked VTE
- •Mechanical heart valve(s)
- •Known antiphospholipid syndrome
- •Known high-risk inherited thrombophilia i) Antithrombin deficiency; ii) Homozygous factor V Leiden; iii) Homozygous prothrombin gene mutation; iv) Compound heterozygosity factor V Leiden and prothrombin gene mutation; v) More than one inherited thrombophilia
- •Need for postpartum aspirin as judged by the local investigator. May include but is not limited to:
- •Documented history of myocardial infarction
- •Documented history of ischemic stroke or transient ischemic attack (TIA)
Arms & Interventions
Aspirin
Aspirin 81 mg daily for six weeks post-randomization (postpartum)
Intervention: Aspirin 81 mg
Placebo
Placebo daily for six weeks post-randomization (postpartum)
Intervention: Placebo
Outcomes
Primary Outcomes
Recruitment Rate
Time Frame: 6 months
Mean recruitment rate per center per month
Secondary Outcomes
- Withdrawals/Loss to Follow-up(9 months)
- Study Drug Compliance(6 months)
- Time Required to Obtain Site Institutional Approvals(24 months)
- Bleeding Event Rate(6 months)
- Consent Rate(6 months)
- VTE Event Rate(6 months)