anti10a Levels in Women Treated With LMWH in the Postpartum Period
Primary Purpose
Venous Thromboembolism
Status
Completed
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
clexane (LMWH)
Sponsored by
About this trial
This is an interventional prevention trial for Venous Thromboembolism focused on measuring postpartum venous thromboembolism, prophylactic dose of low molecular weight heparin, anti 10a
Eligibility Criteria
Inclusion Criteria:
- postpartum women supposed to receive LMWH according to obstetric indications
Exclusion Criteria:
- known allergy to clexane
- active bleeding postpartum
- thrombocytopenia < 75000
- recent cerebrovascular accident / transient ischemic attack (<4 weeks)
- glomerular filtration rate) < 30 ml/min)
- active liver disease
- malignant hypertension (systolic > 200 mmHg, diastolic> 120 mmHg)
Sites / Locations
- Emek medical center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
clexane according to weight group
clexane mg per kg
Arm Description
clexane dose adjusted for woman's weight according to: weight < 90 kg - 40mg, 91-130kg - 60 mg, 131-170kg - 80mg, >170kg-100mg.
clexane dose of 1mg/kg up to 120 mg
Outcomes
Primary Outcome Measures
clexane dosing method in order to achieve anti 10a level >0.2
Secondary Outcome Measures
incidence of anti 10a level of >0.6
incidence of vein thromboembolism
incidence of bleeding events
Full Information
NCT ID
NCT02856295
First Posted
July 13, 2016
Last Updated
November 10, 2022
Sponsor
HaEmek Medical Center, Israel
1. Study Identification
Unique Protocol Identification Number
NCT02856295
Brief Title
anti10a Levels in Women Treated With LMWH in the Postpartum Period
Official Title
anti10a Levels in Women Treated With LMWH in the Postpartum Period for Preventing Vein Thrombosis Events: A Comparison of Two Doses
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
November 20, 2021 (Actual)
Primary Completion Date
August 1, 2022 (Actual)
Study Completion Date
August 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
HaEmek Medical Center, Israel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this study is to compare between anti-10a levels in postpartum women receiving different prophylactic doses of LMWH: one group with LMWH doses adjusted by the women's weight and the second group receiving 1mg/kg to a maximum dose of 120 mg
Detailed Description
pregnancy and postpartum period are associated with increased risk of thromboembolism. this risk is further increased in women with thrombophilia.
This risk is higher in the postpartum period compared with pregnancy period, especially the risk for pulmonary embolism (PE). The American College Of Obstetrics and Gynecologists, The American college of chest physicians and The Royal College of obstetricians and gynecologists recommend using low molecular weight heparin during the postpartum period in women with thrombophilia and women with risk factor for developing thromboembolism. there is no specific guidelines regarding the best protocol based on the level of anti-10 a.
This study will compare between two protocols based on anti-10a levels.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboembolism
Keywords
postpartum venous thromboembolism, prophylactic dose of low molecular weight heparin, anti 10a
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
136 (Actual)
8. Arms, Groups, and Interventions
Arm Title
clexane according to weight group
Arm Type
Active Comparator
Arm Description
clexane dose adjusted for woman's weight according to: weight < 90 kg - 40mg, 91-130kg - 60 mg, 131-170kg - 80mg, >170kg-100mg.
Arm Title
clexane mg per kg
Arm Type
Active Comparator
Arm Description
clexane dose of 1mg/kg up to 120 mg
Intervention Type
Drug
Intervention Name(s)
clexane (LMWH)
Intervention Description
to compare tow doses of clexane for preventing VTE in postpartum women
Primary Outcome Measure Information:
Title
clexane dosing method in order to achieve anti 10a level >0.2
Time Frame
4 hour after the women receive the drug
Secondary Outcome Measure Information:
Title
incidence of anti 10a level of >0.6
Time Frame
4 hour after the women receive the drug
Title
incidence of vein thromboembolism
Time Frame
during the six weeks after delivery
Title
incidence of bleeding events
Time Frame
during the six weeks after delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
postpartum women supposed to receive LMWH according to obstetric indications
Exclusion Criteria:
known allergy to clexane
active bleeding postpartum
thrombocytopenia < 75000
recent cerebrovascular accident / transient ischemic attack (<4 weeks)
glomerular filtration rate) < 30 ml/min)
active liver disease
malignant hypertension (systolic > 200 mmHg, diastolic> 120 mmHg)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zohar Nachum, M.D
Organizational Affiliation
Emek Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Emek medical center
City
Afula
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
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12763484
Citation
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Citation
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Citation
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Citation
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Citation
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Citation
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anti10a Levels in Women Treated With LMWH in the Postpartum Period
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