A Multicenter, Open-Label, Non-Inferiority Randomized Controlled Trial of Postoperative VTE Prevention in Chinese Patients After Colorectal Cancer Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Low Molecular Weight Heparin (dalteparin).
- Who it may be relevant to
- Registry conditions: Colorectal Surgery, VTE (Venous Thromboembolism). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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.
Primary outcome measures
- VTE events, including deep vein thrombosis (DVT) and pulmonary thromboembolism (PE). [Time frame: From enrollment to the end of treatment at 4 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06583330 · BFH-VTE