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

Conditions

Prevention of Venous Thromboembolism

Brief summary

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

Cecilia Becattini, Ugo Pace, Felice Pirozzi, Annibale Donini, Giampiero Avruscio et al. (26 authors)

Blood2022-05-1764 citations

10.1182/blood.2022015796

Rivaroxaban or Placebo for Extended Antithrombotic Prophylaxis after Laparoscopic Surgery for Colorectal Cancer. the PRO-LAPS II Study

Cecilia Becattini, Ugo Pace, Felice Pirozzi, Giampiero Avruscio, Annibale Donini et al. (25 authors)

Blood2021-11-05

10.1182/blood-2021-149093

Rivaroxaban for extended antithrombotic prophylaxis after laparoscopic surgery for colorectal cancer. Design of the PRO-LAPS II STUDY.

Becattini C, Pace U, Rondelli F, Delrio P, Ceccarelli G, Boncompagni M, Graziosi L, Visonà A, Chiari D, Avruscio G, Frasson S, Gussoni G, Biancafarina A, Camporese G, Donini A, Bucci AF, Agnelli G.

2019-12-076 citations

10.1016/j.ejim.2019.11.015

COSIMO - patients with active cancer changing to rivaroxaban for the treatment and prevention of recurrent venous thromboembolism: a non-interventional study.

Cohen AT, Maraveyas A, Beyer-Westendorf J, Lee AYY, Mantovani LG, Bach M, COSIMO Investigators.

2018-09-0416 citations

10.1186/s12959-018-0176-2

Interventions

DRUGRivaroxaban

Tablets

DRUGPlacebo

Tablets

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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.

Design outcomes

Primary

Measure	Time frame	Description
Venous thromboembolism	28±2 days from planned laparoscopic surgery for colorectal cancer in patients randomized to rivaroxaban or placebo.	The primary study outcome is a composite of symptomatic objectively confirmed VTE, asymptomatic ultrasonography-confirmed DVT or VTE-related death.

Countries

Italy

Outcome results

None listed