Clinical trial NCT03055026: Rivaroxaban or Placebo for Extended Antithrombotic Prophylaxis After Laparoscopic Surgery for Colorectal Cancer.
Official title: Rivaroxaban or Placebo for Extended Antithrombotic Prophylaxis After Laparoscopic Surgery for Colorectal Cancer: a Randomized, Double Blind, Placebo-controlled Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prevention of Venous Thromboembolism
Lead sponsor: Fadoi Foundation, Italy
Sponsor class: OTHER
Collaborators: name: University Of Perugia
First posted: 2017-02-16
Enrollment: 582
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility 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.

Primary outcomes:
measure: Venous thromboembolism
timeFrame: 28±2 days from planned laparoscopic surgery for colorectal cancer in patients randomized to rivaroxaban or placebo.
Secondary outcomes:
Other outcomes:
Locations:
city: Pozzuoli
country: Italy
facility: Ospedale Santa Maria delle Grazie
state: Napoli
city: Cittadella
country: Italy
facility: Ospedale di Cittadella
state: Padova
city: Spoleto
country: Italy
facility: Ospedale San Matteo degli Infermi
state: Perugia
city: Pinerolo
country: Italy
facility: Ospedale E. Agnelli
state: Torino
city: Castelfranco Veneto
country: Italy
facility: Ospedale San Giacomo Apostolo
state: Treviso
city: Castellanza
country: Italy
facility: Istituto Clinico Humanitas Mater Domini
state: Varese
city: Arezzo
country: Italy
facility: Ospedale San Donato
city: Firenze
country: Italy
facility: AOU Careggi
city: Foligno
country: Italy
facility: Nuovo Ospedale "San Giovanni Battista"
city: Napoli
country: Italy
facility: AOU Federico II
city: Napoli
country: Italy
facility: IRCCS Fondazione Pascale
city: Padova
country: Italy
facility: Policlinico di Padova
city: Perugia
country: Italy
facility: Ospedale Santa Maria della Misericordia
city: Pesaro
country: Italy
facility: Ospedale San Salvatore
city: Piacenza
country: Italy
facility: Ospedale di Piacenza
city: Roma
country: Italy
facility: Policlinico Gemelli
city: Terni
country: Italy
facility: Ospedale Santa Maria
Study officials:
affiliation: FADOI Foundation
name: Mauro Campanini
role: STUDY_DIRECTOR
References:
citation: Becattini C, Pace U, Pirozzi F, Donini A, Avruscio G, Rondelli F, Boncompagni M, Chiari D, De Prizio M, Visona A, De Luca R, Guerra F, Muratore A, Portale G, Milone M, Castagnoli G, Righini M, Martellucci J, Persiani R, Frasson S, Dentali F, Delrio P, Campanini M, Gussoni G, Vedovati MC, Agnelli G. Rivaroxaban vs placebo for extended antithrombotic prophylaxis after laparoscopic surgery for colorectal cancer. Blood. 2022 Aug 25;140(8):900-908. doi: 10.1182/blood.2022015796.