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

NCT ID: NCT06513481

Last Updated: 2024-07-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 914 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-07-16
• Study Completion Date: 2024-08-31

Brief 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.

Conditions

Colorectal Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Early initiation of drug prophylaxis (within 24 hours after surgery)

Patients who underwent surgery received prophylactic administration of low molecular weight heparin (nardraparin calcium injection) at a time point of 24 hours after surgery，this group carries out early initiation of drug prophylaxis (within 24 hours after surgery)

Nardraparin calcium injection

Intervention Type: DRUG

The dose of nardraparin calcium injection is 100AxaIU/kg, adjusted according to the patient's body weight, and is injected subcutaneously once a day

Late initiation of drug prophylaxis (24 hours after surgery)

Patients who underwent surgery received prophylactic administration of low molecular weight heparin (nardraparin calcium injection) at a time point of 24 hours after surgery，this group carries out late initiation of drug prophylaxis ( 24 hours after surgery)

Nardraparin calcium injection

Intervention Type: DRUG

The dose of nardraparin calcium injection is 100AxaIU/kg, adjusted according to the patient's body weight, and is injected subcutaneously once a day

Interventions

Nardraparin calcium injection

The dose of nardraparin calcium injection is 100AxaIU/kg, adjusted according to the patient's body weight, and is injected subcutaneously once a day

Intervention Type: DRUG

Nardraparin calcium injection

The dose of nardraparin calcium injection is 100AxaIU/kg, adjusted according to the patient's body weight, and is injected subcutaneously once a day

Intervention Type: DRUG

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); 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RenJi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhi-chun Gu

associate professor of pharmacy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhi-Chun Gu

Role: PRINCIPAL_INVESTIGATOR

Department of Pharmacy, Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Central Contacts

Meng Hu, PhD

Role: CONTACT

humeng@renji.com

+8615000090636

Other Identifiers

LY-007-B-AMD-01

Identifier Type: -

Identifier Source: org_study_id