CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 1,110 enrolled
Drug / intervention
Low dose nadroparin +7 moredrug
Likely dose
Low dose nadroparin 2850 IUfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01828697
NCT01828697Phase 4Completed
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Low-molecular-weight Heparin to Prevent Recurrent VTE in Pregnancy: a Randomized Controlled Trial of Two Doses

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)·interventional·Posted Apr 11, 2013·Updated May 26, 2022

In Brief

A Phase 4 clinical trial evaluating Low dose nadroparin, Intermediate dose nadroparin, and 6 other interventions for Deep Venous Thrombosis and Pulmonary Embolism. Completed, enrolled 1,110 participants across 72 sites in 10 countries.

Detailed Summary

This is a randomized-controlled open-label trial comparing two different doses of low-molecular-weight heparin (LMWH) in pregnant patients with a history of previous venous thromboembolism (VTE). Both doses are recommended doses in the 2012 guidelines of the American College of Chest Physicians (ACCP), but it is not known which dose is more efficacious in preventing recurrent venous thromboembolism in pregnancy. Patients enter the study and will be randomized as soon as a home test confirms pregnancy. LMWH will be administered until 6 weeks postpartum. Follow-up will continue until 3 months postpartum. Patients will be recruited by their treating physician, either an obstetrician or internist.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDeep Venous Thrombosis, Pulmonary Embolism
CountriesBelgium, Canada, Denmark, France, Ireland, Netherlands, Norway, Russia, Spain, United States
CollaboratorsNetherlands Organisation for Scientific Research, Aspen Pharma, CHU of Saint Etienne: French Ministry of Health Grant (sponsor of the French part of the study), Rotunda Hospital: Definitive Interventions and Feasibility Awards (DIFA) 2017 (sponsor of the Irish part of the study))

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 11, 2013
Enrollment StartApr 24, 2013
Primary CompletionOct 31, 2021
TodayJul 2, 2026
Enrollment to primary: 8.5 yearsPosted 13.2 years ago

Interventions

Low dose nadroparindrug

Fixed low dose nadroparin: * \< 100 kg: 2850 IU subcutaneously once-daily * 100 kg and above: 3800 IU subcutaneously once-daily

Intermediate dose nadroparindrug

Intermediate weight-adjusted dose nadroparin: * \< 50 kg: 3800 IU subcutaneously once-daily; * 50 to \< 70 kg: 5700 IU subcutaneously once-daily; * 70 to \< 100 kg: 7600 IU subcutaneously once-daily; * 100 kg or above: 9500 IU subcutaneously once-daily.

Low dose enoxaparindrug

Fixed low dose enoxaparin: * \< 100 kg: 40 mg subcutaneously once-daily * 100 kg and above: 60 mg subcutaneously once-daily

Intermediate dose enoxaparindrug

Intermediate weight-adjusted dose enoxaparin: * \< 50 kg: 60 mg subcutaneously once-daily, or; * 50 kg to \< 70 kg: 80 mg subcutaneously once-daily, or; * 70 kg to \< 100 kg: 100 mg subcutaneously once-daily, or; * 100 kg or above: 120 mg subcutaneously once-daily.

Low dose dalteparindrug

Fixed low dose dalteparin: * \< 100 kg: 5000 IU subcutaneously once-daily * 100 kg and above: 7500 IU subcutaneously once-daily

Intermediate dose dalteparindrug

Intermediate weight-adjusted dose dalteparin: * \< 50 kg: 7500 IU subcutaneously once-daily, or; * 50 kg to \< 70 kg: 10000 IU subcutaneously once-daily, or; * 70 kg to \< 100 kg: 12500 IU subcutaneously once-daily, or; * 100 kg or above: 15000 IU subcutaneously once-daily.

Fixed low dose tinzaparindrug

Fixed low dose tinzaparin: * \< 100 kg: 3500 IU subcutaneously once-daily * 100 kg and above: 4500 IU subcutaneously once-daily

Intermediate dose tinzaparindrug

Intermediate weight-adjusted dose tinzaparin: * \< 50 kg: 4500 IU subcutaneously once-daily, or; * 50 kg to \< 70 kg: 7000 IU subcutaneously once-daily, or; * 70 kg to \< 100 kg: 10000 IU subcutaneously once-daily, or; * 100 kg or above: 12000 IU subcutaneously once-daily.