Low Molecular Weight hEparin vs. Aspirin Post-partum

Venous Thromboembolism Clinical Trial

— LEAP  

Official title:

Low Molecular Weight hEparin vs. Aspirin Post-partum

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05058924
• Other study ID #: 20-0275A
• Status: Recruiting
• Phase: N/A
• Start date: August 29, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2023
• Source: Mount Sinai Hospital, Canada
• Contact: Evangelia Vlachodimitropoulou Koumoutsea, MBBS
• Phone: 416-824-9207
• Email: Evangelia.VlachodimitropoulouKoumoutsea[@]sinaihealth.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 30, 2024
• Est. primary completion date: February 29, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• Prophylactic low molecular weight heparin
Enoxaparin 40 mg/dalteparin 5000 U/tinzaparin 4500 U subcutaneously daily for women with weight <100 kg for 6 weeks.
• Low molecular weight heparin and low-dose aspirin
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.

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Mount Sinai Hospital, Canada

Country where clinical trial is conducted

Canada, 

References & Publications (6)

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. — View 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. — View 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 — View 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: 1 — View 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 cli — View 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 medicina — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Enrollment Rate		1 year
Primary	Consent Rate		1 year
Primary	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
Primary	Withdrawal of consent rate		1 year
Primary	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	VTE event rate	VTE must be confirmed either by Doppler ultrasound or V/Q scan or computer tomography (CT). Imaging will not be performed on all patients, only those with symptoms of VTE event. Event rate of VTE will be calculated by number of VTE events by Total days in this study. This number of VTE event is collected during 3 week follow up, 6 week follow up, 3 months follow-up and on early discontinuation date (before 3 months follow up). At the end of the study (after 3 month), the total VTE event rate is calculated.	3 months
Secondary	Bleeding assessment six weeks following delivery	According to the International Society on Thrombosis and Hemostasis (ISTH) scoring system. The bleeding assessments are collected on 3 week phone call and 6 week phone call or early discontinuation visit (before 6 week follow up)	6 weeks
Secondary	Anticoagulation Satisfaction Assessment using the Duke Anticoagulation Satisfaction Scale (DASS)	The maximum value would be 65, indicating the worst quality of life. Minimum value would be 13, indicating best quality of life. This satisfaction assessment would be collected on dosing (day 1), 3 week follow up, 6 week follow up and if early discontinuation.	6 weeks

External Links

•   ISTH-SSC Bleeding Assessment Tool