Rivaroxaban or Placebo for Extended Antithrombotic Prophylaxis After Laparoscopic Surgery for Colorectal Cancer. (PRO-LAPSII)

Fadoi Foundation, Italy

Status and phase: Completed; Phase 3

Conditions: Prevention of Venous Thromboembolism

Treatments: Drug: Placebo; Drug: Rivaroxaban

Study type: Interventional

Funder types: Other

Identifiers

NCT03055026

FADOI.01.2016

Details and patient eligibility

About

Rivaroxaban or placebo for extended antithrombotic prophylaxis after laparoscopic surgery for colorectal cancer: a randomized, double blind, placebo-controlled study.

Enrollment: 582 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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582 participants in 2 patient groups, including a placebo group

Rivaroxaban

Experimental group

Description:

Orally administered, at the dose of 10 mg OD for 3 weeks (extended prophylaxis)

Treatment:

Drug: Rivaroxaban

Placebo

Placebo Comparator group

Description:

Orally administered, OD for 3 weeks (extended prophylaxis)

Treatment:

Drug: Placebo