Back to results

Low Molecular Weight hEparin vs. Aspirin Post-partum (LEAP)

Primary Purpose

Venous Thromboembolism

Status

Recruiting

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Prophylactic low molecular weight heparin

Low molecular weight heparin and low-dose aspirin

About this trial

This is an interventional prevention trial for Venous Thromboembolism focused on measuring Postpartum, Prophylaxis, LMWH

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

Pre-existing indication for therapeutic LMWH
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
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

Sites / Locations

Mount Sinai HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Prophylactic Low Molecular Weight Heparin (LMWH)

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

Arm Description

Prophylactic LMWH for 6 weeks postpartum

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

Outcomes

Primary Outcome Measures

Enrollment Rate

Consent Rate

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).

Withdrawal of consent rate

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).

Secondary Outcome Measures

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.

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)

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.

Full Information

NCT ID

NCT05058924

First Posted

August 25, 2021

Last Updated

January 18, 2023

Sponsor

Mount Sinai Hospital, Canada

1. Study Identification

Unique Protocol Identification Number

NCT05058924

Brief Title

Low Molecular Weight hEparin vs. Aspirin Post-partum

Acronym

LEAP

Official Title

Low Molecular Weight hEparin vs. Aspirin Post-partum

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Recruiting

Study Start Date

August 29, 2021 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mount Sinai Hospital, Canada

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Venous Thromboembolism

Keywords

Postpartum, Prophylaxis, LMWH

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Single Center pilot feasibility RCT

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Prophylactic Low Molecular Weight Heparin (LMWH)

Arm Type

Active Comparator

Arm Description

Prophylactic LMWH for 6 weeks postpartum

Arm Title

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

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Prophylactic low molecular weight heparin

Other Intervention Name(s)

LMWH

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Low molecular weight heparin and low-dose aspirin

Other Intervention Name(s)

LMWH, ASA

Intervention Description

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.

Primary Outcome Measure Information:

Title

Enrollment Rate

Time Frame

1 year

Title

Consent Rate

Time Frame

1 year

Title

Adherence to Prescription

Description

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).

Time Frame

6 weeks

Title

Withdrawal of consent rate

Time Frame

1 year

Title

Rates of contamination

Description

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

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

VTE event rate

Description

Time Frame

3 months

Title

Bleeding assessment six weeks following delivery

Description

Time Frame

6 weeks

Title

Anticoagulation Satisfaction Assessment using the Duke Anticoagulation Satisfaction Scale (DASS)

Description

Time Frame

6 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Evangelia Vlachodimitropoulou Koumoutsea, MBBS

Phone

416-824-9207

Evangelia.VlachodimitropoulouKoumoutsea@sinaihealth.ca

First Name & Middle Initial & Last Name or Official Title & Degree

Ravnit Lomash, BDS

Phone

416-586-4800

Ext

4700

Ravnit.Lomash@sinaihealth.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nadine Shehata, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Evanglia Vlachodimitropoulou Koumoutsea, MBBS

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mount Sinai Hospital

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 1Z5

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Evangelia Vlachodimitropoulou, MD

Phone

4168249207

evangelia.vlachodimitropoulou@sinaihealth.ca

First Name & Middle Initial & Last Name & Degree

Nadine Shehata, MD

First Name & Middle Initial & Last Name & Degree

Evangelia Vlachodimitropoulou, MD

First Name & Middle Initial & Last Name & Degree

Kellie Murphy, MD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

32011647

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.

Results Reference

background

PubMed Identifier

30482767

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.

Results Reference

background

PubMed Identifier

15132746

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.

Results Reference

result

PubMed Identifier

20626619

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.

Results Reference

result

PubMed Identifier

19878532

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.

Results Reference

result

PubMed Identifier

15842354

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.

Results Reference

result

Links:

URL

https://bleedingscore.certe.nl/

Description

ISTH-SSC Bleeding Assessment Tool

Learn more about this trial

Low Molecular Weight hEparin vs. Aspirin Post-partum

We'll reach out to this number within 24 hrs