Clinical trial NCT05058924: Low Molecular Weight hEparin vs. Aspirin Post-partum
Official title: Low Molecular Weight hEparin vs. Aspirin Post-partum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Thromboembolism
Keywords: Postpartum
Prophylaxis
LMWH
Lead sponsor: Mount Sinai Hospital, Canada
Sponsor class: OTHER
First posted: 2021-09-28
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single Center pilot feasibility RCT
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Enrollment Rate
timeFrame: 1 year
measure: Consent Rate
timeFrame: 1 year
measure: Adherence to Prescription
timeFrame: 6 weeks
measure: Withdrawal of consent rate
timeFrame: 1 year
measure: Rates of contamination
timeFrame: 6 weeks
Secondary outcomes:
measure: VTE event rate
timeFrame: 3 months
measure: Bleeding assessment six weeks following delivery
timeFrame: 6 weeks
measure: Anticoagulation Satisfaction Assessment using the PACT Scale
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: Department of Medicine/IHPME, University of Toronto, Division of Hematology, Mount Sinai Hospital
name: Nadine Shehata, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Obstetrics and Gynecology, University of Toronto, Mount Sinai Hospital
name: Evanglia Vlachodimitropoulou Koumoutsea, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Matharu GS, Kunutsor SK, Judge A, Blom AW, Whitehouse MR. Clinical Effectiveness and Safety of Aspirin for Venous Thromboembolism Prophylaxis After Total Hip and Knee Replacement: A Systematic Review and Meta-analysis of Randomized Clinical Trials. JAMA Intern Med. 2020 Mar 1;180(3):376-384. doi: 10.1001/jamainternmed.2019.6108.
citation: Bates SM, Rajasekhar A, Middeldorp S, McLintock C, Rodger MA, James AH, Vazquez SR, Greer IA, Riva JJ, Bhatt M, Schwab N, Barrett D, LaHaye A, Rochwerg B. American Society of Hematology 2018 guidelines for management of venous thromboembolism: venous thromboembolism in the context of pregnancy. Blood Adv. 2018 Nov 27;2(22):3317-3359. doi: 10.1182/bloodadvances.2018024802.
citation: Samsa G, Matchar DB, Dolor RJ, Wiklund I, Hedner E, Wygant G, Hauch O, Marple CB, Edwards R. A new instrument for measuring anticoagulation-related quality of life: development and preliminary validation. Health Qual Life Outcomes. 2004 May 6;2:22. doi: 10.1186/1477-7525-2-22.
citation: Rodeghiero F, Tosetto A, Abshire T, Arnold DM, Coller B, James P, Neunert C, Lillicrap D; ISTH/SSC joint VWF and Perinatal/Pediatric Hemostasis Subcommittees Working Group. ISTH/SSC bleeding assessment tool: a standardized questionnaire and a proposal for a new bleeding score for inherited bleeding disorders. J Thromb Haemost. 2010 Sep;8(9):2063-5. doi: 10.1111/j.1538-7836.2010.03975.x. No abstract available.
citation: Schulman S, Angeras U, Bergqvist D, Eriksson B, Lassen MR, Fisher W; Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in surgical patients. J Thromb Haemost. 2010 Jan;8(1):202-4. doi: 10.1111/j.1538-7836.2009.03678.x. Epub 2009 Oct 30.
citation: Schulman S, Kearon C; Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost. 2005 Apr;3(4):692-4. doi: 10.1111/j.1538-7836.2005.01204.x.