Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, Zuid-Holland, The Netherlands.
Department of Clinical Pharmacy and Toxicology, Leiden University Medical Center, Leiden, Zuid-Holland, The Netherlands.
BMJ Open. 2024 Mar 23;14(3):e078676. doi: 10.1136/bmjopen-2023-078676.
Patients with a first venous thromboembolism (VTE) are at risk of recurrence. Recurrent VTE (rVTE) can be prevented by extended anticoagulant therapy, but this comes at the cost of an increased risk of bleeding. It is still uncertain whether patients with an intermediate recurrence risk or with a high recurrence and high bleeding risk will benefit from extended anticoagulant treatment, and whether a strategy where anticoagulant duration is tailored on the predicted risks of rVTE and bleeding can improve outcomes. The aim of the Leiden Thrombosis Recurrence Risk Prevention (L-TRRiP) study is to evaluate the outcomes of tailored duration of long-term anticoagulant treatment based on individualised assessment of rVTE and major bleeding risks.
The L-TRRiP study is a multicentre, open-label, cohort-based, randomised controlled trial, including patients with a first VTE. We classify the risk of rVTE and major bleeding using the L-TRRiP and VTE-BLEED scores, respectively. After 3 months of anticoagulant therapy, patients with a low rVTE risk will discontinue anticoagulant treatment, patients with a high rVTE and low bleeding risk will continue anticoagulant treatment, whereas all other patients will be randomised to continue or discontinue anticoagulant treatment. All patients will be followed up for at least 2 years. Inclusion will continue until the randomised group consists of 608 patients; we estimate to include 1600 patients in total. The primary outcome is the combined incidence of rVTE and major bleeding in the randomised group after 2 years of follow-up. Secondary outcomes include the incidence of rVTE and major bleeding, functional outcomes, quality of life and cost-effectiveness in all patients.
The protocol was approved by the Medical Research Ethics Committee Leiden-Den Haag-Delft. Results are expected in 2028 and will be disseminated through peer-reviewed journals and during (inter)national conferences.
NCT06087952.
首次发生静脉血栓栓塞症(VTE)的患者存在复发风险。通过延长抗凝治疗可以预防复发性 VTE(rVTE),但这会增加出血风险。目前仍不确定中危复发风险或高危复发及高出血风险的患者是否会从延长抗凝治疗中获益,以及是否可以通过个体化评估 rVTE 和大出血风险来调整抗凝持续时间的策略来改善结局。莱顿血栓复发风险预防(L-TRRiP)研究旨在评估基于 rVTE 和大出血风险个体化评估的长期抗凝治疗持续时间的调整策略的结局。
L-TRRiP 研究是一项多中心、开放标签、基于队列的随机对照试验,纳入了首次发生 VTE 的患者。我们分别使用 L-TRRiP 和 VTE-BLEED 评分来评估 rVTE 和大出血风险。在抗凝治疗 3 个月后,低 rVTE 风险的患者将停止抗凝治疗,高 rVTE 且低出血风险的患者将继续抗凝治疗,而其他所有患者将被随机分配继续或停止抗凝治疗。所有患者将至少随访 2 年。入组将持续到随机组包含 608 例患者;我们估计总共将纳入 1600 例患者。主要结局是随机组在 2 年随访后的 rVTE 和大出血复合发生率。次要结局包括所有患者的 rVTE 和大出血发生率、功能结局、生活质量和成本效益。
该方案已获得莱顿-代尔夫特-海牙医学研究伦理委员会的批准。预计结果将于 2028 年公布,并将通过同行评议的期刊和(国际)会议进行传播。
NCT06087952。