A multicenter seamless prospective cohort study and single-arm confirmatory clinical trial for the venous thromboembolism in gynecological cancer patients. - GOTIC-VTE trial/GOTIC-015

GOTIC0 个研究点目标入组 1,000 人开始时间: 2017年4月6日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•[Registry part] (1) A patients who have a synchronous malignancy or who have been progression-free less than 5 years for a metachronous malignancy (Patients with carcinoma in situ and intramucosal carcinoma are eligible for the study). (2) A patient who is inappropriate as a subject of the study judged by investigator. [Interventional part] (1) Body weigh less than 40 kg. (2) APTT value before the anticoagulation therapy starts prolonged more than 40 seconds. (3) A patient who have not scheduled to undergo surgery during the initial treatment period. (4) A patient who have already received anticoagulant therapy due to underlying diseases before diagnosing VTE ( A patient who have started some anticoagulant therapy after diagnosing VTE is available). (5) A patient who have a synchronous malignancy or who have been progression-free less than 5 years for a metachronous malignancy (Patients with carcinoma in situ and intramucosal carcinoma are eligible for the study). (6) A patient with the following complications that may affect the conduct of this study and the evaluation of this study drug. 1) Bleeding lesion not due to gynecological cancer (including history of cerebrovascular disorder and subarachnoid hemorrhage within 6 months before registration) . 2) Uncontrolled hypertension. 3) Uncontrolled diabetes. 4) Suspicious of acute infective endocarditis. 5) Arterial embolism other than PE (including history).

发起方

GOTIC