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A Study of Enhancing Drug Prophylaxis of Venous Thromboembolism in Chinese Colorectal Cancer Surgery | Clinical Trials | Clareo Health

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A Study of Enhancing Drug Prophylaxis of Venous Thromboembolism in Chinese Colorectal Cancer Surgery

A Study of Enhancing Drug Prophylaxis of Venous Thromboembolism in Chinese Colorectal Cancer Surgery: a Multicenter, Prospective, Observational Cohort Study

NCT06513481•RenJi Hospital

View on ClinicalTrials.gov

Summary

This project intends to conduct a multicenter, prospective, observational cohort study, aiming to explore the impact of the timing of pharmacological thromboprophylaxis initiation on postoperative bleeding risk and the effectiveness of venous thromboembolism (VTE) prevention in Chinese patients after colorectal cancer (CRC) surgery. The research outcomes of this project could provide valuable insights for optimizing the prevention and management of VTE after CRC surgery.

Eligibility

Age

18 - 100 years

Sex

ALL

Healthy Volunteers

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); 2.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.
•3.Known allergy to low molecular weight heparin (LWMH), narcotic drugs or radiocontrast agents; 4.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; 5.Known brain metastases, endocarditis, or history of heparin-induced thrombocytopenia; 6.VTE occurred within 3 months before surgery; 7.Use heparin or oral anticoagulant therapy within 5 days before surgery; 8.Women who are pregnant or breastfeeding; 9.Any situation in which the investigator determines that the subject is not suitable for anticoagulant therapy.

Key Dates

Start Date

July 16, 2024

Primary Completion Date

August 1, 2024

Completion Date

August 31, 2024

Last Updated

July 22, 2024

Enrollment

914

ESTIMATED participants

Conditions

Colorectal Cancer

Interventions

Nardraparin calcium injection

DRUG

Nardraparin calcium injection

DRUG

Contacts

Meng Hu, PhD

CONTACT

+8615000090636 humeng@renji.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 22, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of Enhancing Drug Prophylaxis of Venous Thromboembolism in Chinese Colorectal Cancer Surgery

Inclusion Criteria

Exclusion Criteria

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