NCT06259149

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 914 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 110 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is a single-center, prospective, observational cohort study. The design and implementation of the whole study were carried out according to the CONSORT principle. The study was conducted at the Department of Gastrointestinal Surgery, Renji Hospital, Shanghai Jiao Tong University School of Medicine, and patients were followed up for 28 days. Postoperative patients with colorectal cancer who met the criteria were included. All patients were initiated with low molecular weight heparin (nardraparin calcium injection) for drug prophylaxis after surgery. In clinical practice, patients who underwent surgery at different times on the same day received prophylactic administration of low molecular weight heparin at 24h after surgery, forming two cohorts of early initiation (within 24 hours after surgery) and late initiation (beyond 24 hours after surgery). According to the previous clinical data survey in the past year, since the number of operating tables and the end time of surgery are relatively fixed every day, the number of people in each group of early start and late start groups is about 300 per group per year according to the end time of surgery, which basically conforms to the ratio of 1:1. The dose of low molecular weight heparin (Nardrheparin calcium injection) was 100AxaIU/kg, adjusted according to the patient's body weight, and was administered subcutaneously once a day throughout the patient's hospital stay. All patients underwent color Doppler ultrasound of lower limbs before discharge (7-10 days after surgery) and 28 days after surgery, including screening for thrombus in the proximal deep vein (femoral vein, popliteal vein), distal deep vein (posterior tibial vein, peroneal vein and muscular vein) and venous communication branch. Each enrolled patient will be followed up for 28 days, and all patients will be followed up 28 days after surgery. If the patient is unable to return to the hospital at the scheduled follow-up time point, the patient can be reminded by phone to be admitted for follow-up visit.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-02-01
• Primary completion: 2025-05-01
• Completion: 2025-06-01
• First posted: 2024-02-14
• Last updated: 2024-08-09

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study