Trial | NCT01828697  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    enoxaparin dalteparin nadroparin tinzaparin ...

  • Study Participants

    1110
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 Started
Apr 24
2013
Primary Completion
Oct 31
2021
Study Completion
Oct 31
2021
Last Update
May 26
2022

Drug Low dose nadroparin

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

  • Other names: nadroparin, Fraxiparin

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.

  • Other names: nadroparin, Fraxiparin

Drug Low dose enoxaparin

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

  • Other names: enoxaparin, Clexane

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.

  • Other names: enoxaparin, Clexane

Drug Low dose dalteparin

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

  • Other names: dalteparin, Fragmin

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.

  • Other names: dalteparin, Fragmin

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

  • Other names: tinzaparin, Innohep

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.

  • Other names: tinzaparin, Innohep

Low dose LMWH Active Comparator

Fixed low dose low-molecular-weight heparin: Fixed low dose nadroparin, or; Fixed low dose enoxaparin, or; Fixed low dose dalteparin, or; Fixed low dose tinzaparin.

Intermediate dose LMWH Active Comparator

Intermediate dose low-molecular-weight heparin. Dosing is weight-adjusted according to the protocol. Intermediate dose nadroparin, or; Intermediate dose enoxaparin, or; Intermediate dose dalteparin, or; Intermediate dose tinzaparin.

Criteria 

Inclusion Criteria:

Age: 18 years or older, and;
Pregnancy confirmed by urinary pregnancy test, and;
Gestational age < 14 weeks, and;
Previous objectively confirmed VTE, either unprovoked, in the presence of use of oral contraceptives or estrogen/progestagen use, or related to pregnancy or the postpartum period, or minor risk factors (e.g. long distance travel, minor trauma).

Exclusion Criteria:

Previous VTE related to a major provoking risk factor (e.g. surgery, major trauma or plaster cast immobilisation in the 3 months prior to VTE) as the sole risk factor, or;
Indication for treatment with therapeutic dose anticoagulant therapy (e.g. treatment of acute VTE; permanent use of therapeutic anticoagulants outside of pregnancy), or;
Inability to provide informed consent, or;
Any contraindication listed in the local labelling of LMWH.
No Results Posted