Actively Recruiting

Age: 18Years - 110Years
All Genders
NCT06259149

A Study of Initiation Timing of VTE Prevention After Colorectal Cancer Surgery

Led by RenJi Hospital · Updated on 2024-08-09

914

Participants Needed

1

Research Sites

69 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

A Study of Initiation Timing of VTE Prevention After Colorectal Cancer Surgery

Who Can Participate

Age: 18Years - 110Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age > 18 years old
  • Diagnosed with colorectal cancer at cTMN stage cT1-2, N0 or cT3, N0 or any cT, N1-2
  • Able to receive radical colorectal cancer surgery (laparoscopic or open), with expected operation time >45 minutes
  • Expected postoperative survival time longer than 6 months
  • Patient or guardian agrees to the study and signs informed consent
Not Eligible

You will not qualify if you...

  • Renal insufficiency with creatinine clearance <30 mL/min or hepatic insufficiency with ALT >3 times the upper limit of normal
  • Colorectal cancer with cTMN stage cT4 and/or unresectable local lesions, including extensive lateral pelvic wall invasion, external iliac vascular involvement, tumor invasion into the great sciatic notch, sciatic nerve invasion, or invasion of the second sacrum level and above
  • Known allergy to low molecular weight heparin, narcotic drugs, or radiocontrast agents
  • Presence of systemic bleeding disorders or active bleeding conditions 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
  • Venous thromboembolism occurred within 3 months before surgery
  • Use of heparin or oral anticoagulant therapy within 5 days before surgery
  • Women who are pregnant or breastfeeding
  • Any other condition deemed unsuitable for anticoagulant therapy by the investigator

AI-Screening

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Trial Site Locations

Total: 1 location

1

Department of Gastrointestinal Surgery, Renji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China, 200127

Actively Recruiting

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Research Team

M

Meng Hu, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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