Treatment of Deep Vein Thrombosis of the Lower Extremities w/Low Dose Alteplase

小剂量阿替普酶治疗下肢深静脉血栓

• 批准号: 8565339
• 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/8565339
• 关键词: Alteplase; Anticoagulation; Back; Chronic; Clinical Trials; Coagulation Process; Convalescence; Cytolysis; Deep Vein Thrombosis; Dose; Evaluation; Excision; Fibula Fracture; Funding; Goals; Hearing; Hemorrhage; Incidence Study; Injection of therapeutic agent; Lower Extremity; Patients; Pelvis; Peripheral; Pharmaceutical Preparations; Phase; Postphlebitic Syndrome; Protocols documentation; Recruitment Activity; Recurrence; Regimen; Reporting; Resolution; Risk; Safety; Serious Adverse Event; Symptoms; Syndrome; Testing; Thrombolytic Therapy; Thrombosis; Thrombus; Veins; Venous; disability; efficacy testing; follow-up; thrombolysis

Patients with deep vein thrombosis of the lower extremities andor pelvis are eligible for this protocol if their thrombosis has been symptomatic for no more than 14 days and if their bleeding risk is very low. They are hospitalized for 3-7 days for up to 4 daily injections of rtPA directly into their thrombi. Simultaneously they receive anticoagulation, which is continued for 6 months. Last year we completed the treatment phase of the protocol after accrural of the 30th patient. Extensive thrombolysis had been achieved with low doses of alteplase in every patient, and there have been no serious adverse events. As the protocol is approved for 30 patients , we have completed accrural of patients for the protocol. Although no new patients can be recruited, the protocol now enters follow up phase that last 5 years for each patient. During this follow up period we are permitted to treat the first recurrence of DVT in a previously treated protocol patient if the patient returns to us when 14 days of onset of symptoms. this allows us to get precise evaluation of extent of DVT if a recurrence occurs. Two years ago , we reported successful treatment of a recurrence in a 21yo WM , who 2year after initial treatment developed recurrent extensive DVT during convalescence after ORIF for a fibula fracture. Since that case, we have not heard of any other cases of recurrent DVT in any other previously treated protocol patient. We are hoping to get funding to support a study of incidence of post thrombotic syndromes in these patients.

下肢和/或骨盆深静脉血栓形成的患者，如果血栓形成症状不超过 14 天且出血风险非常低，则符合该方案的资格。他们住院 3-7 天，每天最多 4 次将 rtPA 直接注射到血栓中。同时他们接受抗凝治疗，持续 6 个月。 去年，我们在第 30 名患者入院后完成了该方案的治疗阶段。 每位患者均通过低剂量的阿替普酶实现了广泛的溶栓，并且没有发生严重的不良事件。由于该方案已批准用于 30 名患者，因此我们已完成该方案的患者应计。尽管无法招募新患者，但该方案现已进入每位患者持续 5 年的随访阶段。在此随访期间，如果患者在症状出现 14 天后返回我们这里，我们可以治疗先前治疗过的方案患者的 DVT 首次复发。如果发生复发，这使我们能够准确评估 DVT 的程度。两年前，我们报道了一位 21 岁 WM 复发的成功治疗，该患者在初次治疗 2 年后，因腓骨骨折接受 ORIF 后恢复期出现复发性广泛 DVT。自该病例以​​来，我们还没有听说过任何其他先前接受过治疗的患者复发 DVT 的病例。我们希望获得资金来支持对这些患者血栓后综合征发生率的研究。