NCT06259149 A Study of Initiation Timing of VTE Prevention After Colorectal Cancer Surgery
| NCT ID | NCT06259149 |
| Status | Recruiting |
| Phase | — |
| Sponsor | RenJi Hospital |
| Condition | Colorectal Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 914 participants |
| Start Date | 2024-02-01 |
| Primary Completion | 2025-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 914 participants in total. It began in 2024-02-01 with a primary completion date of 2025-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Criteria: * 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.
Contact & Investigator
Zhi-Chun Gu
PRINCIPAL INVESTIGATOR
Department of Pharmacy, Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Frequently Asked Questions
Who can join the NCT06259149 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 110 Years, studying Colorectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06259149 currently recruiting?
Yes, NCT06259149 is actively recruiting participants. Contact the research team at humeng@renji.com for enrollment information.
Where is the NCT06259149 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06259149 clinical trial?
NCT06259149 is sponsored by RenJi Hospital. The principal investigator is Zhi-Chun Gu at Department of Pharmacy, Renji Hospital, School of Medicine, Shanghai Jiao Tong University. The trial plans to enroll 914 participants.
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