Grant: Project Grant
University of Calgary
$4,563,225.00
The PARTUM (Postpartum Aspirin to Reduce Thromboembolism Undue Morbidity) Trial
EF 2024-25
Résumé
Individuals are at an increased risk of developing blood clots in the legs (deep vein thrombosis) and lungs (pulmonary embolism) during pregnancy and in the postpartum period after they give birth. Postpartum individuals who have additional blood clotting risk factors are often prescribed a daily injectable blood thinner (low molecular-weight heparin). The injectable blood thinners are expensive, cause pain and bruising, and are associated with bleeding complications. Aspirin has been shown to be effective at preventing blood clots after hip and knee surgery and is safe with breastfeeding. Our research team conducted a pilot trial (a test run) in postpartum individuals, and aspirin was an acceptable intervention.
We will now conduct a large trial to answer the question if aspirin is non-inferior to the standard of care injectable blood thinners, to prevent blood clots in their legs and lungs. After delivery, participants will be randomized to low-dose aspirin daily for 6 weeks or their usual care of injectable blood thinners. No extra blood tests or imaging tests are needed. There will be an online questionnaire at 6 weeks and 90 days. A telephone or in person visit will only be needed if there were concerns raised from the online questionnaire, participant preference, or they did not answer the online questionnaire.
The primary outcome is a combination of symptomatic blood clots and death up to 6 weeks after randomization. Other outcomes measured will include other blood clotting complications, bleeding complications, and preeclampsia.
If aspirin can safely prevent serious blood clots in the legs and the lungs after delivery and is similar to an injectable blood thinner, then re-purposing this simple, available and low-cost medication will answer an important knowledge gap and change practice in Canada and around the world.
Programme
Project Grant
Bénéficiaire
Emplacement
Alberta, Canada
Type de bénéficiaire
Academia
Type
Grant
Source
CIHR Funding Decisions Database
Tel que publié
Id
522825
Name
Skeith Leslie
Region
Alberta
Country
Canada
Orgtype
Institution Paid; Research Institution
Instname2
Circulatory and Respiratory Health
Theme2
Clinical
Prcname2
Randomized Controlled Trials
Projecttitle
The PARTUM (Postpartum Aspirin to Reduce Thromboembolism Undue Morbidity) Trial
Programtype2
Operating Grants
Orgnameinp2
University of Calgary
Cihramount2
$4,563,225
Cihrequipment2
$0
Programname2
Project Grant
Keyworddelim
Aspirin; Low-Molecular-Weight Heparin; Postpartum; Prevention; Venous Thromboembolism
Abstract
Individuals are at an increased risk of developing blood clots in the legs (deep vein thrombosis) and lungs (pulmonary embolism) during pregnancy and in the postpartum period after they give birth. Postpartum individuals who have additional blood clotting risk factors are often prescribed a daily injectable blood thinner (low molecular-weight heparin). The injectable blood thinners are expensive, cause pain and bruising, and are associated with bleeding complications. Aspirin has been shown to be effective at preventing blood clots after hip and knee surgery and is safe with breastfeeding. Our research team conducted a pilot trial (a test run) in postpartum individuals, and aspirin was an acceptable intervention.
We will now conduct a large trial to answer the question if aspirin is non-inferior to the standard of care injectable blood thinners, to prevent blood clots in their legs and lungs. After delivery, participants will be randomized to low-dose aspirin daily for 6 weeks or their usual care of injectable blood thinners. No extra blood tests or imaging tests are needed. There will be an online questionnaire at 6 weeks and 90 days. A telephone or in person visit will only be needed if there were concerns raised from the online questionnaire, participant preference, or they did not answer the online questionnaire.
The primary outcome is a combination of symptomatic blood clots and death up to 6 weeks after randomization. Other outcomes measured will include other blood clotting complications, bleeding complications, and preeclampsia.
If aspirin can safely prevent serious blood clots in the legs and the lungs after delivery and is similar to an injectable blood thinner, then re-purposing this simple, available and low-cost medication will answer an important knowledge gap and change practice in Canada and around the world.
Competitiondate
202503
Approvedterm2
6 yrs 0 mth
Pinamesdelim
Skeith, Leslie; BARJAT, Tiphaine; Baumann Kreuziger, Lisa; de Boer, Marjon A; Donnelly, Jennifer; El-Chaar, Darine; Eslick, Renee; Guerrero, Maria C; Holm, Charlotte; Jani, Jacques; Malinowski, Ann K; Roberts, Lara; Rodger, Marc A
Approvedterm
6 ans 0 mois
Cihrcontribution2
~ $4,563,225~ $0~