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Trial Title:
A Multicenter, Open-Label, Non-Inferiority Randomized Controlled Trial of Postoperative VTE Prevention in Chinese Patients After Colorectal Cancer Surgery
NCT ID:
NCT06583330
Condition:
Colorectal Surgery
VTE (Venous Thromboembolism)
Conditions: Official terms:
Thromboembolism
Venous Thromboembolism
Heparin
Heparin, Low-Molecular-Weight
Tinzaparin
Dalteparin
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Low Molecular Weight Heparin (dalteparin)
Description:
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.
Arm group label:
control arm
Arm group label:
experimental group
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.
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
October 2024
Completion date:
March 2027
Lead sponsor:
Agency:
Beijing Friendship Hospital
Agency class:
Other
Source:
Beijing Friendship Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06583330
