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

F

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

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

Trial contacts and locations

17

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Data sourced from clinicaltrials.gov

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