Grant: Project Grant
University of Calgary
$455,175.00
A pilot study assessing the feasibility of a randomized controlled trial evaluating aspirin in postpartum women at risk of developing venous thromboembolism (pilot PAPS: Postpartum Aspirin Prophylaxis Study)
FY 2018-19
Summary
Women are at an increased risk of developing blood clots (venous thrombosis, including deep vein thrombosis or pulmonary embolism) during pregnancy and in the postpartum period. For postpartum women who have additional risk factors for venous thrombosis, it is still unknown whether preventative blood thinners are needed after delivery. Previous studies have evaluated whether daily low-molecular-weight heparin injections after delivery prevents blood clots, however, one major barrier to study recruitment has been patients' lack of comfort with doing the injections at home. Recently, low-dose aspirin has been shown to be effective at preventing blood clots after orthopedic surgery. Low doses of aspirin is considered safe while breastfeeding.
We plan to conduct a study where postpartum women at risk of blood clots are randomized to 6 weeks of low-dose aspirin versus placebo. The main purpose of this pilot study is to see if we can recruit enough women to make a larger trial feasible. Over a 6 week time period we will complete a D-dimer blood test and leg ultrasounds to screen for deep vein thrombosis, as well as track symptoms of blood clots, bleeding and side effects of aspirin. We will also call subjects at 90 days to see if there are any symptoms of blood clots, bleeding or side effects. If this pilot study is feasible, then the clinical information we collect will be used in the larger trial to determine if aspirin prevents more blood clots in postpartum women compared to placebo.
By competing this pilot study we will be able to better prepare for a larger trial to definitively answer the question of whether women at risk of blood clots may benefit from taking aspirin after delivery to prevent blood clots.
Department
Program
Project Grant
Recipient
Location
Alberta, Canada
Recipient Type
Academia
Type
Grant
Source
CIHR Funding Decisions Database
As published
Id
401960
Name
Skeith Leslie
Region
Alberta
Country
Canada
Orgtype
Institution Paid; Research Institution
Instname2
Circulatory and Respiratory Health
Theme2
Clinical
Prcname2
Randomized Controlled Trials 2
Projecttitle
A pilot study assessing the feasibility of a randomized controlled trial evaluating aspirin in postpartum women at risk of developing venous thromboembolism (pilot PAPS: Postpartum Aspirin Prophylaxis Study)
Programtype2
Operating Grants
Orgnameinp2
University of Calgary
Cihramount2
$455,175
Cihrequipment2
$0
Programname2
Project Grant
Keyworddelim
Aspirin; Postpartum Women; Prevention; Venous Thromboembolism
Abstract
Women are at an increased risk of developing blood clots (venous thrombosis, including deep vein thrombosis or pulmonary embolism) during pregnancy and in the postpartum period. For postpartum women who have additional risk factors for venous thrombosis, it is still unknown whether preventative blood thinners are needed after delivery. Previous studies have evaluated whether daily low-molecular-weight heparin injections after delivery prevents blood clots, however, one major barrier to study recruitment has been patients' lack of comfort with doing the injections at home. Recently, low-dose aspirin has been shown to be effective at preventing blood clots after orthopedic surgery. Low doses of aspirin is considered safe while breastfeeding.
We plan to conduct a study where postpartum women at risk of blood clots are randomized to 6 weeks of low-dose aspirin versus placebo. The main purpose of this pilot study is to see if we can recruit enough women to make a larger trial feasible. Over a 6 week time period we will complete a D-dimer blood test and leg ultrasounds to screen for deep vein thrombosis, as well as track symptoms of blood clots, bleeding and side effects of aspirin. We will also call subjects at 90 days to see if there are any symptoms of blood clots, bleeding or side effects. If this pilot study is feasible, then the clinical information we collect will be used in the larger trial to determine if aspirin prevents more blood clots in postpartum women compared to placebo.
By competing this pilot study we will be able to better prepare for a larger trial to definitively answer the question of whether women at risk of blood clots may benefit from taking aspirin after delivery to prevent blood clots.
Competitiondate
201903
Approvedterm2
1 yr 6 mths
Pinamesdelim
Skeith, Leslie; Rodger, Marc A
Approvedterm
1 an 6 mois
Cihrcontribution2
~ $455,175~ $0~