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: 8952839
• 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/8952839
• 关键词: Alteplase; Anticoagulation; Back; Blood flow; Chronic; Clinical Trials; Coagulation Process; Convalescence; Cytolysis; Deep Vein Thrombosis; Dose; Evaluation; Excision; Fibula Fracture; Funding; Goals; Hemorrhage; Injection of therapeutic agent; Leg; Lower Extremity; Patients; Pelvis; Peripheral; Pharmaceutical Preparations; Phase; Postphlebitic Syndrome; Protocols documentation; Recruitment Activity; Recurrence; Regimen; Reporting; Resolution; Retreatment; Risk; Safety; Serious Adverse Event; Symptoms; Syndrome; Testing; Therapeutic; Thrombolytic Therapy; Thrombosis; Thrombus; Veins; Venous; deep vein; 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. We have completed the treatment phase of the protocol after accrual 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. This past year, one previously treated protocol patient notified us of a recurrent DVT in the previously treated leg, after having stopped anticoagulation for a few months. Since this recurrence occurred at 5years +1 month , or 1 month beyond stipulated follow up period in the protocol, this patient required and received a special exemption for retreatment which again successfully and safely restored blood flow and patency of his deep veins. While the thrombolytic treatment appears to be safe and therapeutic, it does not appear to obviate the need for long term anticoagulation in patients who present with idiopathic DVT.

如果下肢和/或骨盆深静脉血栓形成的患者出现血栓症状不超过14天并且出血风险非常低，则有资格参加本方案。他们住院3-7天，每天最多4次将rtPA直接注射到他们的血栓中。同时，他们接受抗凝治疗，持续6个月。 在招募第30例患者后，我们完成了方案的治疗阶段。 在每例患者中，使用低剂量阿替普酶均实现了广泛的溶栓，且未发生严重不良事件。由于该方案获批用于30例患者，我们已完成该方案的患者招募。虽然不能招募新患者，但该方案现在进入每例患者持续5年的随访阶段。在此随访期间，如果患者在症状发作14天后返回我们，则允许我们治疗既往治疗方案患者的DVT首次复发。这使我们能够在复发时对DVT的范围进行精确评估。两年前，我们报告了一名21岁的WM患者的复发成功治疗，该患者在初次治疗后2年，在腓骨骨折ORIF后恢复期发生复发性广泛DVT。在过去的一年里，一名先前接受过治疗的方案患者通知我们，在停止抗凝治疗几个月后，先前接受过治疗的腿部发生了复发性DVT。由于该复发发生在5年+1个月，或超出方案规定的随访期1个月，因此该患者要求并获得了特殊豁免进行再治疗，再次成功安全地恢复了血流和深静脉通畅。虽然溶栓治疗似乎是安全和治疗性的，但它似乎并不需要对特发性DVT患者进行长期抗凝治疗。

项目成果

Biochemical dynamics relevant to the safety of low-dose, intraclot alteplase for deep vein thrombosis.

与低剂量血栓内阿替普酶治疗深静脉血栓的安全性相关的生化动力学。

• DOI: 10.1016/j.trsl.2012.01.025
• 发表时间: 2012-09
• 期刊: Translational research : the journal of laboratory and clinical medicine
• 作者: Lozier JN;Cullinane AM;Nghiem K;Chang R;Horne MK 3rd
• 通讯作者: Horne MK 3rd

Treatment of high-risk venous thrombosis patients using low-dose intraclot injections of recombinant tissue plasminogen activator and regional anticoagulation.

使用低剂量重组组织纤溶酶原激活剂凝块内注射和区域抗凝治疗高危静脉血栓患者。

• DOI: 10.1016/j.jvir.2012.09.017
• 发表时间: 2013
• 期刊: Journal of vascular and interventional radiology : JVIR
• 作者: Chang,Richard;Butman,JohnA;Lonser,RussellR;Sherry,RichardM;Pandalai,PrakashK;Horne3rd,McDonaldK;Lozier,JayN
• 通讯作者: Lozier,JayN