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Optimization of Postpartum Thromboprophylaxis

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ClinicalTrials.gov Identifier: NCT05058924
Recruitment Status : Active, not recruiting
First Posted : September 28, 2021
Last Update Posted : September 28, 2021
Sponsor:
Information provided by (Responsible Party):
Mount Sinai Hospital, Canada

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.

Condition or disease Intervention/treatment Phase
Venous Thromboembolism Drug: Prophylactic low molecular weight heparin Drug: Low molecular weight heparin and low-dose aspirin Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single Center pilot feasibility RCT
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Optimization of Postpartum Thromboprophylaxis: is 6 Weeks Necessary?
Actual Study Start Date : August 29, 2021
Estimated Primary Completion Date : June 22, 2022
Estimated Study Completion Date : June 22, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Prophylactic Low Molecular Weight Heparin (LMWH)
Prophylactic LMWH for 6 weeks postpartum
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.
Other Name: LMWH

Experimental: Prophylactic Low Molecular Weight Heparin (LMWH) + Low Dose Aspirin
Prophylactic LMWH for 3 weeks followed by low dose Aspirin for 3 weeks.
Drug: 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.
Other Names:
  • LMWH
  • ASA




Primary Outcome Measures :
  1. Enrollment Rate [ Time Frame: 1 year ]
  2. Consent Rate [ Time Frame: 1 year ]
  3. Adherence to Prescription [ Time Frame: 6 weeks ]
    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).

  4. Withdrawal of consent rate [ Time Frame: 1 year ]
  5. Rates of contamination [ Time Frame: 6 weeks ]
    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 :
  1. VTE event rate [ Time Frame: 3 months ]
    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.

  2. Bleeding assessment six weeks following delivery [ Time Frame: 6 weeks ]
    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)

  3. Anticoagulation Satisfaction Assessment using the Duke Anticoagulation Satisfaction Scale (DASS) [ Time Frame: 6 weeks ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05058924


Locations
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Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1Z5
Sponsors and Collaborators
Mount Sinai Hospital, Canada
Investigators
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Principal Investigator: Nadine Shehata, MD Department of Medicine/IHPME, University of Toronto, Division of Hematology, Mount Sinai Hospital
Principal Investigator: Evang Vlachodimitropoulou Koumoutsea, MBBS Department of Obstetrics and Gynecology, University of Toronto, Mount Sinai Hospital
  Study Documents (Full-Text)

Documents provided by Mount Sinai Hospital, Canada:
Study Protocol  [PDF] September 13, 2021
Informed Consent Form  [PDF] July 27, 2021

Additional Information:
Publications of Results:
Other Publications:
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Responsible Party: Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier: NCT05058924    
Other Study ID Numbers: 20-0275A
First Posted: September 28, 2021    Key Record Dates
Last Update Posted: September 28, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mount Sinai Hospital, Canada:
Postpartum
Prophylaxis
LMWH
Additional relevant MeSH terms:
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Heparin, Low-Molecular-Weight
Molecular Mechanisms of Pharmacological Action
Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Aspirin
Heparin
Calcium heparin
Tinzaparin
Dalteparin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Anticoagulants