Overview

Rivaroxaban or Placebo for Extended Antithrombotic Prophylaxis After Laparoscopic Surgery for Colorectal Cancer.

Status:
Unknown status
Trial end date:
2020-12-01
Target enrollment:
0
Participant gender:
All
Summary
Rivaroxaban or placebo for extended antithrombotic prophylaxis after laparoscopic surgery for colorectal cancer: a randomized, double blind, placebo-controlled study.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Fadoi Foundation, Italy
Collaborator:
University Of Perugia
Treatments:
Rivaroxaban
Criteria
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

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.