Treatment Of Acute Deep Vein Thrombosis Of The Lower Ext

下肢急性深静脉血栓的治疗

• 批准号: 7215868
• 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/7215868
• 关键词: acute disease /disorder; cardiovascular disorder chemotherapy; clinical trials; dosage; drug adverse effect; drug screening /evaluation; hemorrhage; human subject; human therapy evaluation; limbs; longitudinal human study; lung imaging /visualization /scanning; patient oriented research; pharmacokinetics; plasminogen activator; pulmonary circulation obstruction; recombinant proteins; therapy adverse effect; therapy design /development; venous thrombosis

The objective of the study is to evaluate thrombolytic therapy using recombinant tissue plasminogen activator (rtPA) for treatment of acute deep vein thrombosis (DVT) of the lower extremity. While the conventional therapy, anticoagulation alone, is highly effective in prevention of life threatening pulmonary embolism, it does not preserve venous function in the affected leg, often leading to postphlebitic syndromes in subsequent years. The study is designed to evaluate efficacy, safety, and cost of this form of treatment for restoration of venous function in the lower extremity.This spring,we have completed treatment of 20 patients as as was alotted for this pilot study. All except one patient had significant improvement. Five patients also had evidence of pulmonary embolism by lung scans prior to start of their treatment whereas only two patients have had evidence of small asymptomatic pulmonary emboli that developed 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 patients have required blood transfusions and no other complications have occurred. Over a followup period that ranges from 1 month to 5 years, none of our patients have developed either recurrent deep vein thrombosis or progression to postphlebitic syndromes.Pharmacokinetic studies in our patients have made major contributions to improving our understanding of thrombolytic therapy and has led us to design and open a new protocol (04-CC-0178;Principal investigator:Dr Horne)for DVT of the lower extremity using substantially lower doses of tPA that theoretically should be an even safer, and even more affordable regimen to preserve the quality of life for victims of DVT.This protocol, 98-CC-0067, will be terminated so that we can devote our energies to the new protocol.

本研究的目的是评价使用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（DVT）的溶栓疗法。虽然传统的治疗，单独抗凝，是非常有效的预防危及生命的肺栓塞，它不保留静脉功能，在受影响的腿，往往导致静脉炎后综合征在随后的几年。这项研究旨在评估这种治疗形式对下肢静脉功能恢复的有效性、安全性和成本。今年春天，我们完成了20例患者的治疗，这是这项试点研究的一部分。除一名患者外，其他所有患者均有明显改善。5例患者在开始治疗前通过肺部扫描也有肺栓塞的证据，而只有2例患者在治疗期间有小的无症状肺栓塞的证据，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。没有患者需要输血，也没有发生其他并发症。在1个月至5年的随访期内，我们的患者均未发生复发性深静脉血栓形成或进展为静脉炎后综合征。我们患者的药代动力学研究为提高我们对溶栓治疗的理解做出了重大贡献，并引导我们设计和开放了一个新的方案（04-CC-0178;主要研究者：Horne博士）用于下肢DVT，使用显著较低剂量的tPA，理论上应该是一种更安全，更实惠的方案，以保持DVT患者的生活质量。该方案，98-CC-0067，将被终止，以便我们能够将精力投入到新的协议中。

项目成果

Daily catheter-directed single dosing of t-PA in treatment of acute deep venous thrombosis of the lower extremity.

• DOI: 10.1016/s1051-0443(07)61832-6
• 发表时间: 2001-02
• 期刊: Journal of vascular and interventional radiology : JVIR
• 作者: Richard Chang;Richard O. Cannon;Clara C. Chen;J. L. Doppman;Thomas H. Shawker;Donna Jo Mayo;Bradford J. Wood;McDonald K. Horne