Article Dans Une Revue Thrombosis Research Année : 2016

Low-molecular-weight heparin to prevent recurrent venous thromboembolism in pregnancy: Rationale and design of the Highlow study, a randomised trial of two doses

Suzanne M Bleker
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Fionnuala Ní Áinle
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Anne Flem Jacobsen
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Wessel Ganzevoort
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Résumé

Background: Women with a history of venous thromboembolism (VTE) have a 2% to 10% absolute risk of VTE recurrence during subsequent pregnancies. Therefore, current guidelines recommend that all pregnant women with a history of VTE receive pharmacologic thromboprophylaxis. The optimal dose of low-molecular-weight heparin (LMWH) for thromboprophylaxis is unknown. In the Highlow study (NCT 01828697; www. highlowstudy.org), we compare a fixed low dose of LMWH with an intermediate dose of LMWH for the prevention of pregnancy-associated recurrent VTE. We present the rationale and design features of this study. Methods: The Highlow study is an investigator-initiated, multicentre, international, open-label, randomised trial. Pregnant women with a history of VTE and an indication for ante-and postpartum pharmacologic thromboprophylaxis are included before 14 weeks of gestation. The primary efficacy outcome is symptomatic recurrent VTE during pregnancy and 6 weeks postpartum. The primary safety outcomes are clinically relevant bleeding, blood transfusions before 6 weeks postpartum and mortality. Patients are closely monitored to detect cutaneous reactions to LMWH and are followed for 3 months after delivery. A central independent adjudication committee adjudicates all suspected outcome events.

Conclusion:

The Highlow study is the first large randomised controlled trial in pregnancy that will provide highquality evidence on the optimal dose of LWMH thromboprophylaxis for the prevention of recurrent VTE in pregnant women with a history of VTE.

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hal-04822077 , version 1 (06-12-2024)

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Suzanne M Bleker, Andrea Buchmüller, Céline Chauleur, Fionnuala Ní Áinle, Jennifer Donnelly, et al.. Low-molecular-weight heparin to prevent recurrent venous thromboembolism in pregnancy: Rationale and design of the Highlow study, a randomised trial of two doses. Thrombosis Research, 2016, 144, pp.62 - 68. ⟨10.1016/j.thromres.2016.06.001⟩. ⟨hal-04822077⟩
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