NCT05058924

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

August 29, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 28, 2021

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

March 3, 2025

Status Verified

May 1, 2023

Enrollment Period

2.5 years

First QC Date

August 25, 2021

Last Update Submit

February 26, 2025

Conditions

Venous Thromboembolism

Keywords

PostpartumProphylaxisLMWH

Outcome Measures

Primary Outcomes (5)

  • Enrollment Rate

    1 year

  • Consent Rate

    1 year

  • Adherence to Prescription

    Utilization of co-interventions for both: control group (6 week of Low Molecular Weight Heparin) or Treatment group (3 week of low molecular weight Heparin and 3 week of low dose aspirin).

    6 weeks

  • Withdrawal of consent rate

    1 year

  • Rates of contamination

    List of the concurrent medication will be gathered on 3 week follow up, 6 week follow up and early discontinuation (before 6 weeks).

    6 weeks

Secondary Outcomes (3)

  • VTE event rate

    3 months

  • Bleeding assessment six weeks following delivery

    6 weeks

  • Anticoagulation Satisfaction Assessment using the PACT Scale

    6 weeks

Study Arms (2)

Prophylactic Low Molecular Weight Heparin (LMWH)

ACTIVE COMPARATOR

Prophylactic LMWH for 6 weeks postpartum

Drug: Prophylactic low molecular weight heparin

Prophylactic Low Molecular Weight Heparin (LMWH) + Low Dose Aspirin

EXPERIMENTAL

Prophylactic LMWH for 3 weeks followed by low dose Aspirin for 3 weeks.

Drug: Low molecular weight heparin and low-dose aspirin

Interventions

Prophylactic low molecular weight heparinDRUG

Enoxaparin 40 mg/dalteparin 5000 U/tinzaparin 4500 U subcutaneously daily for women with weight \<100 kg for 6 weeks.

Also known as: LMWH
Prophylactic Low Molecular Weight Heparin (LMWH)
Low molecular weight heparin and low-dose aspirinDRUG

Enoxaparin 40 mg/dalteparin 5000 U/tinzaparin 4500 U subcutaneously daily for women with weight \<100 kg for three weeks followed by ASA 81 mg orally daily for three weeks.

Also known as: LMWH, ASA
Prophylactic Low Molecular Weight Heparin (LMWH) + Low Dose Aspirin

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Personal history of unprovoked VTE prior to pregnancy or hormone associated VTE and not prescribed therapeutic anticoagulation or
  • Family history (1st degree relative) of VTE and antithrombin deficiency, protein C or protein S deficiency or
  • Combined thrombophilia or homozygous for the factor V Leiden mutation or prothrombin gene mutation, and family history of VTE (1st degree relative) and
  • \> 18 years of age.

You may not qualify if:

  • Pre-existing indication for therapeutic LMWH
  • Contraindication to ASA:
  • Known ASA allergy
  • Documented history of gastrointestinal ulcer
  • Known platelet count \< 50x10\^9/L at any time during the current pregnancy or postpartum
  • Contraindication to LMWH, e.g. known allergy
  • Active bleeding at any site, excluding physiological vaginal bleeding
  • Patients with bleeding disorders
  • Known severe hypertension (SBP \>200mm/hg and/or DBP \>120mm/hg) during the current pregnancy or postpartum

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G 1Z5, Canada

Location

Related Publications (7)

  • 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.

    PMID: 32011647BACKGROUND

  • 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.

    PMID: 30482767BACKGROUND

  • 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.

    PMID: 15132746RESULT

  • 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.

    PMID: 20626619RESULT

  • 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.

    PMID: 19878532RESULT

  • 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.

    PMID: 15842354RESULT

  • Vlachodimitropoulou E, Malinowski K, Kaplovitch E, Carrier M, Shehata N. Low-molecular-weight heparin vs aspirin postpartum (LEAP): a single-center pilot randomized control trial. Blood Vessel Thromb Hemost. 2025 Sep 10;2(4):100106. doi: 10.1016/j.bvth.2025.100106. eCollection 2025 Nov.

    PMID: 41280308DERIVED

MeSH Terms

Conditions

Venous Thromboembolism

Interventions

Heparin, Low-Molecular-WeightAspirin

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

HeparinGlycosaminoglycansPolysaccharidesCarbohydratesSalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Nadine Shehata, MD

    Department of Medicine/IHPME, University of Toronto, Division of Hematology, Mount Sinai Hospital

    PRINCIPAL INVESTIGATOR

  • Evanglia Vlachodimitropoulou Koumoutsea, MBBS

    Department of Obstetrics and Gynecology, University of Toronto, Mount Sinai Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Single Center pilot feasibility RCT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2021

First Posted

September 28, 2021

Study Start

August 29, 2021

Primary Completion

February 29, 2024

Study Completion

March 1, 2024

Last Updated

March 3, 2025

Record last verified: 2023-05

Locations

CA(1)