临床试验/NCT06583330

NCT06583330尚未招募不适用

A Multicenter, Open-Label, Non-Inferiority Randomized Controlled Trial of Postoperative VTE Prevention in Chinese Patients After Colorectal Cancer Surgery

Beijing Friendship Hospital0 个研究点目标入组 1,448 人开始时间: 2024年10月最近更新: 2024年9月4日

适应症

干预措施

试验速览

阶段: 不适用
状态: 尚未招募
发起方: Beijing Friendship Hospital
入组人数: 1,448
主要终点: VTE events, including deep vein thrombosis (DVT) and pulmonary thromboembolism (PE).

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

research objective

Optimize VTE prevention management after CRC surgery.
Improve the prevention and treatment level of VTE in current perioperative patients.
Reduce the social burden of VTE related diseases.

Participants will:

start low molecular weight heparin prophylaxis within 24 hours post-surgery.
The prophylactic regimen for the experimental group lasted 14 days, while the control group received it for 28 days. Low molecular weight heparin is given subcutaneously at a dose of 0.3ml once daily.
atients underwent lower limb color Doppler ultrasound on postoperative days 7 ± 2, 14 ± 3, and 28 ± 5, which included screening for thrombosis in the proximal deep veins (femoral, popliteal), distal deep veins (posterior tibial, fibular, and muscular veins), and their perforating branches.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Prevention
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Age>18 years old; Diagnosed with colorectal cancer and undergoing curative, palliative, or other limited surgeries (laparoscopic or open surgery), with an estimated surgery time of>45 minutes; Expected postoperative survival>6 months; Expected Caprini score of ≥ 5 on the first day after surgery; The patient agrees to the research plan and signs an informed consent form.

排除标准

•Renal dysfunction (CrCl<30 mL/min) or liver dysfunction (ALT>3 times the upper limit of normal); Known allergies to LMWH, anesthetics, or contrast agents; There is a systemic bleeding disorder or bleeding tendency, such as active peptic ulcer, uncontrolled hypertension, cerebral thrombosis within 6 months, cerebral hemorrhage, or a history of neurosurgical surgery; Known brain metastases, endocarditis, or previous heparin induced thrombocytopenia; VTE occurred within 3 months before surgery; Use heparin or oral anticoagulant therapy within 5 days before surgery; Pregnant or lactating women; Pregnant or lactating women; Any conditions that researcher determines the subject not suitable for anticoagulant therapy.

研究组 & 干预措施

experimental group

Experimental

Low molecular weight heparin should be initiated for drug prevention within 24 hours after surgery, with a preventive course of 14 days

干预措施: Low Molecular Weight Heparin (dalteparin) (Drug)

control arm

Active Comparator

All patients should initiate low molecular weight heparin for drug prophylaxis within 24 hours after surgery, with a prophylaxis course of 28 days

干预措施: Low Molecular Weight Heparin (dalteparin) (Drug)

结局指标

主要结局

VTE events, including deep vein thrombosis (DVT) and pulmonary thromboembolism (PE).

时间窗: From enrollment to the end of treatment at 4 weeks

次要结局

未报告次要终点

研究者

发起方

Beijing Friendship Hospital

申办方类型

Other

责任方

Sponsor

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