A Study of Initiation Timing of VTE Prevention After Colorectal Cancer Surgery
A Study of Initiation Timing of VTE Prevention After Colorectal Cancer Surgery: a Single-center, Prospective, Observational Cohort Study
RenJi Hospital
914 participants
Feb 1, 2024
OBSERVATIONAL
Conditions
Summary
This project intends to conduct a single-center, prospective, observational cohort study to explore the impact of the timing of drug prophylaxis on the risk of postoperative bleeding and the preventive effect of VTE in the prevention and management of postoperative venous thromboembolism (VTE) after colorectal cancer (CRC) surgery in Chinese population, and to determine its application and promotion value. The research results of this project can provide useful reference for optimizing the prevention and management of VTE after CRC operation.
Eligibility
Inclusion Criteria3
- ① Age \> 18 years old;
- ② The patient was diagnosed with colorectal cancer, and the cTMN stage was cT1-2, N0 or cT3, N0 or any cT, N1-2; (3) The patient was diagnosed with colorectal cancer and was able to receive radical surgery (laparoscopic or open surgery). The expected operation time was \>45 minutes, and the expected postoperative survival time was \>6 months.
- ④ The patient or guardian agrees to the study plan and signs the informed consent.
Exclusion Criteria7
- ① Renal insufficiency (CrCl\<30 mL/min) or hepatic insufficiency (ALT\> 3 times the upper limit of normal);
- The patient was diagnosed with colorectal cancer with a cTMN stage of cT4 and/or local unresectable lesions. Unresectable local recurrent lesions included: (1) extensive lateral pelvic wall invasion, (2) external iliac vascular involvement, (3) tumor invasion into the great sciatic notch, sciatic nerve invasion, and (4) invasion of the second sacrum level and above.
- Known allergy to low molecular weight heparin (LWMH), narcotic drugs or radiocontrast agents; The presence of systemic hemorrhagic disease or bleeding tendency, such as active peptic ulcer, uncontrolled hypertension, cerebral thrombosis, cerebral hemorrhage or neurosurgical history within 6 months;
- known brain metastases, endocarditis, or history of heparin-induced thrombocytopenia;
- VTE occurred within 3 months before surgery;
- Use heparin or oral anticoagulant therapy within 5 days before surgery; Women who are pregnant or breastfeeding;
- Any situation in which the investigator determines that the subject is not suitable for anticoagulant therapy.
Interventions
The dose of nardraparin calcium injection is 100AxaIU/kg, adjusted according to the patient's body weight, and is injected subcutaneously once a day
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06259149