Status:
NOT_YET_RECRUITING
A Multicenter, Open-Label, Non-Inferiority Randomized Controlled Trial of Postoperative VTE Prevention in Chinese Patients After Colorectal Cancer Surgery
Lead Sponsor:
Beijing Friendship Hospital
Conditions:
Colorectal Surgery
VTE (Venous Thromboembolism)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
research objective 1. Optimize VTE prevention management after CRC surgery. 2. Improve the prevention and treatment level of VTE in current perioperative patients. 3. Reduce the social burden of VTE ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
1448 Patients enrolled
Trial Details
Trial ID
NCT06583330
Start Date
October 1 2024
End Date
March 1 2027
Last Update
September 4 2024
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