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

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 related diseases.

Participants will:

1. start low molecular weight heparin prophylaxis within 24 hours post-surgery.
2. 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.
3. 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Surgery; VTE (Venous Thromboembolism)
• Intervention / Treatment: Drug: Low Molecular Weight Heparin (dalteparin)

• Study Type: Interventional
• Enrollment (Estimated): 1448
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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 Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental group; Low molecular weight heparin should be initiated for drug prevention within 24 hours after surgery, with a preventive course of 14 days	Drug: Low Molecular Weight Heparin (dalteparin); All patients initiated low molecular weight heparin for drug prevention within 24 hours after surgery. The prevention course for the experimental group patients was 14 days, while the prevention course for the control group patients was 28 days. Low molecular weight heparin is administered subcutaneously once daily at a dose of 0.3ml.
Active Comparator: control arm; All patients should initiate low molecular weight heparin for drug prophylaxis within 24 hours after surgery, with a prophylaxis course of 28 days	Drug: Low Molecular Weight Heparin (dalteparin); All patients initiated low molecular weight heparin for drug prevention within 24 hours after surgery. The prevention course for the experimental group patients was 14 days, while the prevention course for the control group patients was 28 days. Low molecular weight heparin is administered subcutaneously once daily at a dose of 0.3ml.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
VTE events, including deep vein thrombosis (DVT) and pulmonary thromboembolism (PE).	From enrollment to the end of treatment at 4 weeks

Collaborators and Investigators

• Sponsor: Beijing Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: September 1, 2024
• First Submitted That Met QC Criteria: September 1, 2024
• First Posted (Actual): September 4, 2024

Study Record Updates

• Last Update Posted (Actual): September 4, 2024
• Last Update Submitted That Met QC Criteria: September 1, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thromboembolism; Venous Thromboembolism; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Heparin; Heparin, Low-Molecular-Weight; Tinzaparin; Dalteparin
• Other Study ID Numbers: BFH-VTE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No