TILE试点试验研究协议:丁沙巴林入以预防血栓后综合征研究协议
Ilia Makedonov1,2, Susan Kahn3, Jameel Abdulrehman4
1Department of Medicine, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada imake012@uottawa.ca.
BMJ open
|October 31, 2023
概括
这项试点试验旨在调查在利瓦洛克萨班之前短时间服用丁扎是否能预防深静脉血栓症后的血栓后综合征 (PTS). 它评估了对DVT预防进行更大规模研究的可行性.
科学领域:
- 血管医学 血管医学
- 临床试验 临床试验
- 药理学 药理学是指药理学的学科.
背景情况:
- 血栓后综合征 (PTS) 是深静脉血栓症 (DVT) 后的慢性静脉不全并发症,影响20-50%的患者.
- 目前已确定的PTS治疗选择有限,需要有效的预防策略.
- 低分子量肝素可能在DVT急性阶段提供抗炎功效,可能降低PTS风险.
研究的目的:
- 评估一项更大规模的最终试验的可行性,评估丁扎帕林在预防PTS中的作用.
- 通过Villalta尺度来确定6个月后发展PTS的患者比例.
- 评估研究可行性,包括患者的资格,招募和治疗坚持.
主要方法:
- 一个由调查员发起的,多中心的,开放的,评估员盲目的试点试验 (NCT04794569).
- 患有急性症状常见的股骨或腹DVT的患者随机获得tinzaparin,其次是rivaroxaban或单独的rivaroxaban.
- 主要结局:6个月后PTS发病率和研究可行性指标. 二次结果包括生活质量,出血和复发性VTE.
主要成果:
- 本节不适用,因为这项研究是试点试验,结果尚未公布.
结论:
- 这项试点研究旨在确定一项更大规模试验的可行性,该试验旨在研究后血栓形成综合征的新型预防策略.
- 这些发现将为设计一项最终研究提供信息,以评估tinzaparin在DVT患者的疗效.
- 这项研究将为早期抗炎治疗的潜力提供见解,以减轻DVT的长期并发症.
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