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

Capital Medical University

Status: Not yet enrolling

Conditions: VTE (Venous Thromboembolism); Colorectal Surgery

Treatments: Drug: Low Molecular Weight Heparin (dalteparin)

Study type: Interventional

Funder types: Other

Identifiers

NCT06583330

BFH-VTE

Details and patient eligibility

About

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.

Enrollment: 1,448 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,448 participants in 2 patient groups

experimental group

Experimental group

Description:

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

Treatment:

Drug: Low Molecular Weight Heparin (dalteparin)

control arm

Active Comparator group

Description:

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

Treatment:

Drug: Low Molecular Weight Heparin (dalteparin)