Preventing Postpartum Venous Thromboembolism With Low-Molecular-Weight Heparin: The PP-HEP Pilot Randomised Controlled Trial.

IF 5.4 3区材料科学 Q2 CHEMISTRY, PHYSICAL

ACS Applied Energy Materials Pub Date : 2024-09-05 DOI:10.1111/1471-0528.17943

Marc Blondon, Marine Claver, Emilienne Celetta, Marc Righini, Begoña Martinez de Tejada

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引用次数: 0

Abstract

Objective: Uncertainty surrounds the risk-benefit of low-molecular-weight heparin to prevent postpartum venous thromboembolism (VTE). Data from randomised clinical trials (RCT) are critically needed, but recent feasibility studies in North America yielded low participation rates, with <1 enrolment per month per centre. Our aim was to assess the feasibility of a trial of postpartum short-term enoxaparin in Europe.

Design: Pragmatic, open-label pilot randomised controlled trial (RCT).

Setting: Swiss tertiary hospital.

Population: Postpartum women, within 48 h of delivery, deemed at intermediate risk of VTE with at least one major risk factor (morbid obesity, thrombophilia, emergency caesarean section, pre-eclampsia, preterm delivery, intrauterine growth restriction or systemic peripartum infection) and/or at least two minor risk factors.

Methods: Participants were randomised to enoxaparin 40-60 mg once daily for 10 days or no treatment, with a 90-day follow-up.

Main outcome measures: Participation rate and study acceptance (randomised participants among women in whom informed consent was sought).

Results: Recruitment was open for 25 weeks in 2022. Among 1504 postpartum women, 480 were eligible and 77 were randomised. The recruitment rate was 3.1 per week (13.3 per month) and the study acceptance was 23.8%. At 3 months, there was no VTE event, but one major, one nonmajor obstetrical bleeding and one surgical site complication, all in the enoxaparin group.

Conclusions: This pilot RCT of postpartum thromboprophylaxis set in Switzerland yielded greater participation rate and acceptance than previous attempts in North America. It calls for a large, international, collaborative trial to guide this important clinical decision.

Trial registration: ClinicalTrial.gov identifier: NCT05878899 and NCT04153760.

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用低分子量肝素预防产后静脉血栓栓塞：PP-HEP 试点随机对照试验。

目的：低分子量肝素预防产后静脉血栓栓塞症（VTE）的风险与收益之间存在不确定性。目前急需随机临床试验（RCT）的数据，但最近在北美进行的可行性研究的参与率较低：设计：务实、开放标签试点随机对照试验（RCT）：地点：瑞士三级医院：人群：产后 48 小时内，被视为 VTE 中危产妇，至少有一个主要危险因素（病态肥胖、血栓性疾病、紧急剖腹产、先兆子痫、早产、宫内生长受限或全身性围产期感染）和/或至少两个次要危险因素：参与者被随机分配到依诺肝素（enoxaparin）40-60 毫克，每天一次，为期 10 天或不治疗，随访 90 天：主要结果测量指标：参与率和研究接受度（征得知情同意的妇女中的随机参与者）：结果：2022 年的招募工作持续了 25 周。在 1504 名产后妇女中，480 人符合条件，77 人被随机选中。招募率为每周 3.1 人（每月 13.3 人），研究接受率为 23.8%。3 个月后，依诺肝素组未发生 VTE 事件，但发生了一起大出血、一起非大出血和一起手术部位并发症：这项在瑞士进行的产后血栓预防试点 RCT 比之前在北美进行的尝试获得了更高的参与率和接受度。因此，需要开展一项大型的国际合作试验，为这一重要的临床决策提供指导：试验注册：ClinicalTrial.gov identifier：试验注册：ClinicalTrial.gov 标识符：NCT05878899 和 NCT04153760。

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来源期刊

ACS Applied Energy Materials Materials Science-Materials Chemistry

CiteScore

10.30

自引率

6.20%

发文量

1368

期刊介绍： ACS Applied Energy Materials is an interdisciplinary journal publishing original research covering all aspects of materials, engineering, chemistry, physics and biology relevant to energy conversion and storage. The journal is devoted to reports of new and original experimental and theoretical research of an applied nature that integrate knowledge in the areas of materials, engineering, physics, bioscience, and chemistry into important energy applications.