VTE program at Nara towards the establishment of Universal Screening (VENUS study)

未提供0 个研究点目标入组 100 人开始时间: 2024年12月23日最近更新: 2025年1月17日

试验速览

暂无简介。

•[Primary enrollment]
•Patients scheduled to undergo surgical treatment for gynecological tumors (including benign and malignant tumors) at Nara Medical University Hospital
•Patients with any of the following risk factors for PTE
•<Risk factors for PTE>
•(1) Risk of the case
•Malignant disease or suspected malignant disease
•Large ovarian mass or myoma occupying the pelvic cavity.
•(2) Risks associated with the disease or surgery
•Neoadjuvant chemotherapy prior to surgery.
•Severe infectious diseases
•Bed rest for more than 48 hours before surgery.
•Bed rest for more than 48 hours after surgery.
•Central venous catheter
•(3) Risks associated with the background of each patient
•Age >= 60 years old
•Previous history of venous thrombosis
•Thrombophilia or family history of venous thrombosis
•Hormone therapy
•Severe varicose veins of the lower extremities
•Congestive heart failure or respiratory failure
•Paralysis of the lower limbs
•Patients aged 18 years and over
•Patients with written consent
•[Secondary enrollment]
•Patients who were enrolled in the primary registry
•Patients who have undergone surgery

•[At the time of primary enrollment]
•Bleeding from causes other than the primary disease
•Thrombocytopenia (platelet count < 100,000/microL)
•The following hemorrhagic complications; gastrointestinal ulcer, gastrointestinal diverticulitis, colitis, acute bacterial endocarditis, poorly controlled severe hypertension (systolic >=180 mmHg or diastolic >=120 mmHg), poorly controlled severe diabetes (HbA1c >=10%), disseminated intravascular coagulation (DIC), and others.
•Severe hepatic dysfunction (e.g., ALT more than 3 times the institutional reference value)
•Hypersensitivity to heparin, low molecular weight heparin, or danaparoid
•History of cerebral hemorrhage
•Central nervous system surgery or ophthalmic surgery within 3 months
•Creatinine clearance < 40 ml/min
•History or suspected history of heparin-induced thrombocytopenia (HIT)
•Preoperative pulmonary thromboembolism or deep vein thrombosis
•Taking anticoagulants or antiplatelet agents
•Extreme emaciation
•Patients deemed by the physician to be inappropriate for registration.
•[At the time of Secondary enrollment]
•Patients who are considered to be unable to undergo protocol treatment due to intraoperative or postoperative bleeding

Incidence of Major Bleeding

未报告次要终点

发起方

未提供