Timing of VTE prevention after colorectal cancer surgery

A Study of Initiation Timing of VTE Prevention After Colorectal Cancer Surgery: a Single-center, Prospective, Observational Cohort Study

This study is testing whether giving a blood-thinning medication right after colorectal cancer surgery can help prevent blood clots and bleeding better than waiting longer to give it.

Quick facts

• Study type: Observational
• Enrollment: 914 (estimated)
• Ages: 18 Years to 110 Years
• Sex: All
• Sponsor: RenJi Hospital (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06259149 on ClinicalTrials.gov

What this trial studies

This project is a single-center, prospective, observational cohort study aimed at examining how the timing of drug prophylaxis affects the risk of postoperative bleeding and the prevention of venous thromboembolism (VTE) in patients undergoing colorectal cancer surgery. Patients will receive low molecular weight heparin either within 24 hours after surgery or later, and will be followed for 28 days to assess outcomes. The study is designed according to the CONSORT principles and aims to provide insights for optimizing VTE management in this patient population.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years old diagnosed with colorectal cancer who are eligible for radical surgery.

Not a fit: Patients with renal or hepatic insufficiency, or those with advanced or unresectable colorectal cancer, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved protocols for VTE prevention, reducing complications and enhancing recovery for colorectal cancer surgery patients.

How similar studies have performed: While this approach is based on existing practices, the specific timing of prophylaxis in this context is being explored for the first time in this population.

Eligibility criteria

Inclusion Criteria:

* ① Age \> 18 years old;

  ② The patient was diagnosed with colorectal cancer, and the cTMN stage was cT1-2, N0 or cT3, N0 or any cT, N1-2; (3) The patient was diagnosed with colorectal cancer and was able to receive radical surgery (laparoscopic or open surgery). The expected operation time was \>45 minutes, and the expected postoperative survival time was \>6 months.

  ④ The patient or guardian agrees to the study plan and signs the informed consent.

Exclusion Criteria:

* ① Renal insufficiency (CrCl\<30 mL/min) or hepatic insufficiency (ALT\> 3 times the upper limit of normal);

  * The patient was diagnosed with colorectal cancer with a cTMN stage of cT4 and/or local unresectable lesions. Unresectable local recurrent lesions included: (1) extensive lateral pelvic wall invasion, (2) external iliac vascular involvement, (3) tumor invasion into the great sciatic notch, sciatic nerve invasion, and (4) invasion of the second sacrum level and above.

Known allergy to low molecular weight heparin (LWMH), narcotic drugs or radiocontrast agents; The presence of systemic hemorrhagic disease or bleeding tendency, such as active peptic ulcer, uncontrolled hypertension, cerebral thrombosis, cerebral hemorrhage or neurosurgical history within 6 months;

* known brain metastases, endocarditis, or history of heparin-induced thrombocytopenia;

  * VTE occurred within 3 months before surgery;

    * Use heparin or oral anticoagulant therapy within 5 days before surgery; Women who are pregnant or breastfeeding;

      * Any situation in which the investigator determines that the subject is not suitable for anticoagulant therapy.

Where this trial is running

Shanghai, Shanghai Municipality

• Department of Gastrointestinal Surgery, Renji Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Principal investigator: Zhi-Chun Gu — Department of Pharmacy, Renji Hospital, School of Medicine, Shanghai Jiao Tong University
• Study coordinator: Meng Hu, PhD

Conditions Colorectal Cancer