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.

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Key information

Conditions

Colorectal Surgery Cardiovascular Diseases Embolism and Thrombosis Thromboembolism VTE (Venous Thromboembolism) Vascular Diseases Venous Thromboembolism

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low Molecular Weight Heparin (dalteparin)

Drug

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.

Primary outcomes

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

Time frame: From enrollment to the end of treatment at 4 weeks

Sponsors and collaborators

Lead sponsor

Beijing Friendship Hospital

Other

Registry information

Important dates

Study start: 2024
Primary completion: 2027
Study completion: 2027
First posted: Sep 4, 2024
Registry last updated: Sep 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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