Treatment of Acute Deep Vein Thrombosis of the Lower Extremity with Intraclot, P

Intraclot P治疗急性下肢深静脉血栓

• 批准号: 6431761
• 负责人: Richard T Chang
• 金额: --
• 依托单位: CLINICAL CENTER
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/6431761
• 关键词: aorta; bioassay; cardiovascular disorder chemotherapy; cardiovascular pharmacology; clinical research; critical care; disease /disorder model; dosage; drug adverse effect; drug screening /evaluation; endotoxins; human subject; human tissue; hypotension; intensive care; interleukin 1; interleukin 2; laboratory rat; limbs; organ culture; protein purification; shock; tumor necrosis factor alpha; vascular resistance; vasodilatation; venous thrombosis

The objective of the study is to evaluate recombinant tissue plasminogen activator (rtPA) for treatment of acute deep vein thrombosis of the lower extremity. The study is designed to evaluate efficacy, safety, and cost of this form of treatment for restoration of venous function in the lower extremity. Seven patients have been treated, all with excellent results. Only two patients have had evidence of small pulmonary emboli during treatment, detected on ventilation perfusion lung scans that are obtained in all patients accepted into the protocol. None of these patients were clinically symptomatic. One patient developed a non-life-threatening biceps hematoma probably induced by automatic blood pressure monitoring during the rtPA treatment. No other complications have occurred. Preliminary results have been submitted for publication in a case report for JAMA, and in an article submitted to the American Journal of Medicine.

本研究的目的是评价重组组织型纤溶酶原激活剂（rtPA）治疗急性下肢深静脉血栓形成的疗效。该研究旨在评估这种治疗形式恢复下肢静脉功能的有效性、安全性和成本。7名患者接受了治疗，均取得了良好的效果。只有两名患者在治疗期间有小肺栓塞的证据，在方案接受的所有患者中获得的通气灌注肺扫描中检测到。这些患者均无临床症状。1例患者发生了非危及生命的二头肌血肿，可能是rtPA治疗期间自动血压监测引起的。未发生其他并发症。初步结果已提交发表在JAMA的病例报告和提交给美国医学杂志的一篇文章中。