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

Not Applicable

Not yet recruiting

• Conditions: Colorectal Surgery; VTE (Venous Thromboembolism)
• Interventions: Drug: Low Molecular Weight Heparin (dalteparin)

• Registration Number: NCT06583330
• Lead Sponsor: Beijing Friendship Hospital

Brief Summary

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.
...

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-01
• Study First Submitted QC: 2024-09-01
• Last Update Submitted: 2024-09-01
• Study First Posted: 2024-09-04
• Last Update Posted: 2024-09-04
• Study Start: 2024-10
• Primary Completion: 2027-01
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1448

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental group	Low Molecular Weight Heparin (dalteparin)	Low molecular weight heparin should be initiated for drug prevention within 24 hours after surgery, with a preventive course of 14 days
control arm	Low Molecular Weight Heparin (dalteparin)	All patients should initiate low molecular weight heparin for drug prophylaxis within 24 hours after surgery, with a prophylaxis course of 28 days

Primary Outcome Measures

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