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Venous ThromboembolismPhase 4NCT02856295

anti10a Levels in Women Treated With LMWH in the Postpartum Period

A Phase 4 study testing clexane (LMWH) in people with Venous Thromboembolism, run by HaEmek Medical Center, Israel at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Venous Thromboembolism
What is being tested?
clexane (LMWH)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
136 participants
Where
1 siteIsrael
Study dates
20 Nov 2021to 1 Aug 2022
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • postpartum women supposed to receive LMWH according to obstetric indications

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Israel1 site

  • Emek medical center

    Afula

Other trials in Israel

About this study

Official title: anti10a Levels in Women Treated With LMWH in the Postpartum Period for Preventing Vein Thrombosis Events: A Comparison of Two Doses

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

Read the 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.

Being tested
clexane (LMWH)
Keywords
postpartum venous thromboembolism, prophylactic dose of low molecular weight heparin, anti 10a
Medical subject headings
Venous Thromboembolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • clexane (LMWH)Drug

    to compare tow doses of clexane for preventing VTE in postpartum women

Study groups in NCT02856295
Study groupRoleWhat they receive
clexane according to weight groupActive comparatorclexane dose adjusted for woman's weight according to: weight < 90 kg - 40mg, 91-130kg - 60 mg, 131-170kg - 80mg, >170kg-100mg.
Receives: Drug: clexane (LMWH)
clexane mg per kgActive comparatorclexane dose of 1mg/kg up to 120 mg
Receives: Drug: clexane (LMWH)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. clexane dosing method in order to achieve anti 10a level >0.2

    Measured: 4 hour after the women receive the drug

Secondary outcomes (3)

  1. incidence of anti 10a level of >0.6

    Measured: 4 hour after the women receive the drug

  2. incidence of vein thromboembolism

    Measured: during the six weeks after delivery

  3. incidence of bleeding events

    Measured: during the six weeks after delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2016 (estimated)
  2. Study start20 Nov 2021
  3. Primary completion1 Aug 2022
  4. Study completion1 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
136 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02856295
Sponsor's protocol ID
EMC59-12
Status last verified
Nov 2022
First submitted
13 Jul 2016
Last updated
15 Nov 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • 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.

    PubMed 12763484

  • Hellgren M. Hemostasis during normal pregnancy and puerperium. Semin Thromb Hemost. 2003 Apr;29(2):125-30. doi: 10.1055/s-2003-38897.

    PubMed 12709915

  • Practice bulletin no. 124: inherited thrombophilias in pregnancy. Obstet Gynecol. 2011 Sep;118(3):730-740. doi: 10.1097/AOG.0b013e3182310c6f.

    PubMed 21860314

  • 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.

    PubMed 18572147

  • 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.

    PubMed 10546719

  • 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.

    PubMed 12825542

  • 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.

    PubMed 16287790

  • 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.

    PubMed 18248600

  • 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.

    PubMed 10453824

  • 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.

    PubMed 22315276

  • American College of Obstetricians and Gynecologists. ACOG Committee Opinion: safety of Lovenox in pregnancy. Obstet Gynecol. 2002 Oct;100(4):845-6.

    PubMed 12387283

  • 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.

    PubMed 24519568

  • 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.

    PubMed 15383488

  • 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.

    PubMed 21923455

  • 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.

    PubMed 18827132

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing clexane (LMWH) in people with Venous Thromboembolism, run by HaEmek Medical Center, Israel at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

clexane dosing method in order to achieve anti 10a level >0.2 (time frame: 4 hour after the women receive the drug). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02856295, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2022.

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