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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
HaEmek Medical Center, Israel
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

First Posted
July 13, 2016
Last Updated
November 10, 2022
Sponsor
HaEmek Medical Center, Israel
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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:
PubMed Identifier
12763484
Citation
Bremme KA. Haemostatic changes in pregnancy. Best Pract Res Clin Haematol. 2003 Jun;16(2):153-68. doi: 10.1016/s1521-6926(03)00021-5.
Results Reference
result
PubMed Identifier
12709915
Citation
Hellgren M. Hemostasis during normal pregnancy and puerperium. Semin Thromb Hemost. 2003 Apr;29(2):125-30. doi: 10.1055/s-2003-38897.
Results Reference
result
PubMed Identifier
21860314
Citation
Practice bulletin no. 124: inherited thrombophilias in pregnancy. Obstet Gynecol. 2011 Sep;118(3):730-740. doi: 10.1097/AOG.0b013e3182310c6f.
Results Reference
result
PubMed Identifier
18572147
Citation
Scifres CM, Macones GA. The utility of thrombophilia testing in pregnant women with thrombosis: fact or fiction? Am J Obstet Gynecol. 2008 Oct;199(4):344.e1-7. doi: 10.1016/j.ajog.2008.04.051. Epub 2008 Jun 24.
Results Reference
result
PubMed Identifier
10546719
Citation
Gherman RB, Goodwin TM, Leung B, Byrne JD, Hethumumi R, Montoro M. Incidence, clinical characteristics, and timing of objectively diagnosed venous thromboembolism during pregnancy. Obstet Gynecol. 1999 Nov;94(5 Pt 1):730-4. doi: 10.1016/s0029-7844(99)00426-3.
Results Reference
result
PubMed Identifier
12825542
Citation
Chang J, Elam-Evans LD, Berg CJ, Herndon J, Flowers L, Seed KA, Syverson CJ. Pregnancy-related mortality surveillance--United States, 1991--1999. MMWR Surveill Summ. 2003 Feb 21;52(2):1-8.
Results Reference
result
PubMed Identifier
16287790
Citation
Heit JA, Kobbervig CE, James AH, Petterson TM, Bailey KR, Melton LJ 3rd. Trends in the incidence of venous thromboembolism during pregnancy or postpartum: a 30-year population-based study. Ann Intern Med. 2005 Nov 15;143(10):697-706. doi: 10.7326/0003-4819-143-10-200511150-00006.
Results Reference
result
PubMed Identifier
18248600
Citation
Pomp ER, Lenselink AM, Rosendaal FR, Doggen CJ. Pregnancy, the postpartum period and prothrombotic defects: risk of venous thrombosis in the MEGA study. J Thromb Haemost. 2008 Apr;6(4):632-7. doi: 10.1111/j.1538-7836.2008.02921.x. Epub 2008 Jan 31.
Results Reference
result
PubMed Identifier
10453824
Citation
McColl MD, Walker ID, Greer IA. The role of inherited thrombophilia in venous thromboembolism associated with pregnancy. Br J Obstet Gynaecol. 1999 Aug;106(8):756-66. doi: 10.1111/j.1471-0528.1999.tb08395.x.
Results Reference
result
PubMed Identifier
22315276
Citation
Bates SM, Greer IA, Middeldorp S, Veenstra DL, Prabulos AM, Vandvik PO. VTE, thrombophilia, antithrombotic therapy, and pregnancy: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e691S-e736S. doi: 10.1378/chest.11-2300.
Results Reference
result
PubMed Identifier
12387283
Citation
American College of Obstetricians and Gynecologists. ACOG Committee Opinion: safety of Lovenox in pregnancy. Obstet Gynecol. 2002 Oct;100(4):845-6.
Results Reference
result
PubMed Identifier
24519568
Citation
Bain E, Wilson A, Tooher R, Gates S, Davis LJ, Middleton P. Prophylaxis for venous thromboembolic disease in pregnancy and the early postnatal period. Cochrane Database Syst Rev. 2014 Feb 11;(2):CD001689. doi: 10.1002/14651858.CD001689.pub3.
Results Reference
result
PubMed Identifier
15383488
Citation
Bates SM, Greer IA, Hirsh J, Ginsberg JS. Use of antithrombotic agents during pregnancy: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest. 2004 Sep;126(3 Suppl):627S-644S. doi: 10.1378/chest.126.3_suppl.627S.
Results Reference
result
PubMed Identifier
21923455
Citation
Shapiro NL, Kominiarek MA, Nutescu EA, Chevalier AB, Hibbard JU. Dosing and monitoring of low-molecular-weight heparin in high-risk pregnancy: single-center experience. Pharmacotherapy. 2011 Jul;31(7):678-85. doi: 10.1592/phco.31.7.678.
Results Reference
result
PubMed Identifier
18827132
Citation
Fox NS, Laughon SK, Bender SD, Saltzman DH, Rebarber A. Anti-factor Xa plasma levels in pregnant women receiving low molecular weight heparin thromboprophylaxis. Obstet Gynecol. 2008 Oct;112(4):884-9. doi: 10.1097/AOG.0b013e31818638dc. Erratum In: Obstet Gynecol. 2009 Mar;113(3):742.
Results Reference
result

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anti10a Levels in Women Treated With LMWH in the Postpartum Period

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