NCT01828697

Comparison of Low and Intermediate Dose Low-molecular-weight Heparin to Prevent Recurrent Venous Thromboembolism in Pregnancy

Low-molecular-weight Heparin to Prevent Recurrent VTE in Pregnancy: a Randomized Controlled Trial of Two Doses

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,110 (actual)
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Deep Venous Thrombosis
• Pulmonary Embolism

Interventions

Type	Name	Description
DRUG	Low dose nadroparin	Fixed low dose nadroparin: * \< 100 kg: 2850 IU subcutaneously once-daily * 100 kg and above: 3800 IU subcutaneously once-daily
DRUG	Intermediate dose nadroparin	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.
DRUG	Low dose enoxaparin	Fixed low dose enoxaparin: * \< 100 kg: 40 mg subcutaneously once-daily * 100 kg and above: 60 mg subcutaneously once-daily
DRUG	Intermediate dose enoxaparin	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.
DRUG	Low dose dalteparin	Fixed low dose dalteparin: * \< 100 kg: 5000 IU subcutaneously once-daily * 100 kg and above: 7500 IU subcutaneously once-daily
DRUG	Intermediate dose dalteparin	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.
DRUG	Fixed low dose tinzaparin	Fixed low dose tinzaparin: * \< 100 kg: 3500 IU subcutaneously once-daily * 100 kg and above: 4500 IU subcutaneously once-daily
DRUG	Intermediate dose tinzaparin	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.

Timeline

• Start date: 2013-04-24
• Primary completion: 2021-10-31
• Completion: 2021-10-31
• First posted: 2013-04-11
• Last updated: 2022-05-26

Locations

72 sites across 10 countries: United States, Belgium, Canada, Denmark, France, Ireland, Netherlands, Norway, Russia, Spain