The CardioPAT Project: A Randomized Trial

NCT02058134 | Terminated

• 1 other identifier: H-3-2013-169
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether intra- and postoperative use of the cardioPAT® cell saver decreases the need for allogenic red blood cell transfusion in patients, who undergo open heart surgery (with cardiopulmonary bypass) and preoperatively have an increased risk for bleeding.

Conditions

Coronary Artery Disease; Aortic Stenosis; Aortic Insufficiency; Mitral Insufficiency; Aortic Aneurysm

Outcome Measures

Primary Outcomes (1)

• The rate of allogenic transfusion with red blood cells (SAG-M)

  The entire stay at the Department of Cardiothoracic Surgery, Rigshospitalet (approximately one week after surgery)

Study Arms (2)

Control group

NO INTERVENTION

Interventional group

EXPERIMENTAL

For patients in the interventional group we use a CardioPAT cell saver intra- and postoperatively.

Device: cardioPAT cell saver

Interventions

cardioPAT cell saver DEVICE

Interventional group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All the women
• Men with a hemoglobin \< 8mmol/L
• Men \> 75 years of age with combined procedures, that is combined CABG and valve surgery, regardless of preoperative hemoglobin level
• Sub-acute patients can be included

You may not qualify if:

• Re-operation within the first 24 hours
• Known clotting disorders (coagulopathy) or hematological diseases
• Sepsis, f ex due to Endocarditis
• Patients who are already enrolled in other studies, where data from the studies are at risk of interfering with each other
• Jehovah's witnesses
• Acute surgery (\< 24 hours)

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Department of Cardiothoracic Surgery, Rigshospitalet

Copenhagen, København Ø, 2100, Denmark

Location

MeSH Terms

Conditions

Coronary Artery Disease; Aortic Valve Stenosis; Aortic Valve Insufficiency; Mitral Valve Insufficiency; Aortic Aneurysm

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aneurysm; Aortic Diseases

Study Officials

• Erika Nodin, MD

  Department of Cardiothoracic Surgery, Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scholar

Study Record Dates

• First Submitted: February 6, 2014
• First Posted: February 7, 2014
• Study Start: December 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 18, 2018

Record last verified: 2016-08

Locations

DK (1)