A comparison between rivaroxaban and placebo for the prevention of deep vein thrombosis or pulmonary embolism afetr laparoscpic surgery for colorectal cancer after initial heparin prophylaxis

Phase 1

• Conditions: Prevention of venous thromboembolism after laparoscopic surgery for colorectal cancer; MedDRA version: 20.0Level: LLTClassification code 10067650Term: Pulmonary embolism prophylaxisSystem Organ Class: 100000004865; MedDRA version: 21.1Level: LLTClassification code 10012108Term: Deep venous thrombosis prophylaxisSystem Organ Class: 100000004865; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2015-005090-20-IT
• Lead Sponsor: FONDAZIONE FADOI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-17
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 646

Inclusion Criteria

- Objective diagnosis of Colorectal Cancer
- Elective laparoscopic surgery for colorectal cancer
- Whatever the stage of cancer
- Antithrombotic prophylaxis with LMWH administered for 7±2 days after surgery
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 446

Exclusion Criteria

- age < 18 years
- surgery for non-cancer disease
- duration of surgery < 45 min
- Conversion to open surgery
- other indication for anticoagulant therapy
- known cerebral metastases
- kidney or liver failure
- known hemorrhagic diathesis or high risk for bleeding
- history of intracerebral bleeding or neurosurgery within 6 months, history of heparin induced thrombocytopenia
- pregnancy or lactation
- refusal of informed consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified