Venous Thromboembolism Clinical Trial
Official title:
Postpartum Prophylaxis for PE Randomized Control Trial Pilot: A Pilot Study Assessing Feasibility of a Randomized, Open-label Trial of Low-Molecular-Weight-Heparin for Postpartum Prophylaxis in Women at Risk of Developing Venous Thromboembolism
The purpose of this study is to determine if it is feasible to conduct a multi-center randomized trial to determine whether a blood thinner, low-molecular-weight-heparin (LMWH), is effective at preventing blood clots, thromboembolism (VTE), in postpartum women at risk.
The PROPSER pilot is a randomized, open-label pilot study comparing prophylactic low
molecular weight heparin (LMWH) to saline placebo. The PROSPER pilot study will assess the
feasibility of conducting a full trial as measured by the number of subjects recruited per
center per month. In addition, clinical data will be collected to determine an estimate of
the primary outcome event rate (symptomatic VTE or asymptomatic proximal deep vein
thrombosis (DVT) and major bleeding event rate for the full trial in LMWH and control
groups. If our pilot results indicate that no substantial changes are needed to the study
design, we will include the pilot data in the primary and secondary outcome analyses for the
full trial (i.e. a "Vanguard trial" or internal pilot trial).
Eligible consenting women at risk of postpartum thrombosis will be randomized within 36
hours after delivery of the placenta and will be equally allocated to 2 trial arms, either
the treatment group: prophylactic-dose LMWH, subcutaneously once daily for 10 days (+/-3
days), or the control group.
At 10 days (+/- 3 days), all women will have a study visit to assess for study outcomes,
including bilateral leg ultrasound screening for VTE and a D-dimer test. A final telephone
follow-up will occur at 90 days for outcome assessment of subsequent VTE, bleeding or other
adverse events.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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