Venous Thromboembolism
Conditions
Keywords
Postpartum, Prophylaxis, LMWH
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.
Interventions
DRUGProphylactic low molecular weight heparin
Enoxaparin 40 mg/dalteparin 5000 U/tinzaparin 4500 U subcutaneously daily for women with weight \<100 kg for 6 weeks.
DRUGLow 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.
Sponsors
Mount Sinai Hospital, Canada
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Single Center pilot feasibility RCT
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Enrollment Rate | 1 year | — |
| Consent Rate | 1 year | — |
| Adherence to Prescription | 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). |
| Withdrawal of consent rate | 1 year | — |
| Rates of contamination | 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
| Measure | Time frame | Description |
|---|---|---|
| VTE event rate | 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. |
| Bleeding assessment six weeks following delivery | 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) |
| Anticoagulation Satisfaction Assessment using the Perception of Anticoagulant Treatment Questionnaire (PACT-Q©) Scale | 6 weeks | Treatment expectations: score 1-5, higher score =higher expectations of treatment Convenience: score 1-100, reverse score, higher score= more convenient Anticoagulation treatment satisfaction: score 1-100, higher score=higher patient satisfaction |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORNadine Shehata, MD
Department of Medicine/IHPME, University of Toronto, Division of Hematology, Mount Sinai Hospital
PRINCIPAL_INVESTIGATOREvanglia Vlachodimitropoulou Koumoutsea, MBBS
Department of Obstetrics and Gynecology, University of Toronto, Mount Sinai Hospital
Outcome results
None listed