The CardioPAT Project: A Randomized Trial
Primary Purpose
Coronary Artery Disease, Aortic Stenosis, Aortic Insufficiency
Status
Terminated
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
cardioPAT cell saver
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Sites / Locations
- Department of Cardiothoracic Surgery, Rigshospitalet
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control group
Interventional group
Arm Description
For patients in the interventional group we use a CardioPAT cell saver intra- and postoperatively.
Outcomes
Primary Outcome Measures
The rate of allogenic transfusion with red blood cells (SAG-M)
Secondary Outcome Measures
Full Information
NCT ID
NCT02058134
First Posted
February 6, 2014
Last Updated
April 16, 2018
Sponsor
Rigshospitalet, Denmark
1. Study Identification
Unique Protocol Identification Number
NCT02058134
Brief Title
The CardioPAT Project: A Randomized Trial
Official Title
CardioPAT Project - Reducing the Need for Allogenic Blood Transfusion After On-pump Cardiac Surgery With Intra- and Postoperative Use of a New Device: a Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Terminated
Why Stopped
Due to other trials in the department
Study Start Date
December 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
4. Oversight
5. Study Description
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.
Detailed Description
This scientific study will be conducted as a randomized controlled trial with N = 146, and therefore n = 2 x 73.
Randomization will be carried out as a simple 1:1 randomization in to the following groups:
Control group: undergo heart surgery with blood conserving strategies that are currently standard routine at Rigshospitalet.
Interventional group: undergo heart surgery with intra- and postoperative use of the cardioPAT cell saver. The cardioPAT collects blood from the operative site and from the chest tubes, thereafter it washes and concentrates the red blood cells. This blood can then be returned to the patient. Furthermore, this group will also receive the same blood conserving strategies as the control group.
Randomization will be stratified for the inclusion criteria to ensure that the two groups have the same amount of women, men with a hemoglobin under 8 mmol/l and men over 75 years with double procedures.
All legally competent adults who receive an on-pump open heart surgery at the Department of Cardiothoracic Surgery at Rigshospitalet will be screened for participation in this trial.
Inclusion criteria:
Patients with an increased risk for bleeding, who undergo open heart surgery, that is:
Women
Men with a hemoglobin < 8mmol/L
Men > 75 years of age with combined procedures, that is f.ex. combined CABG and valve surgery, regardless of preoperative hemoglobin level
Exclusion criteria:
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)
The aim of the study is to investigate:
Whether the requirement for allogenic transfusion of red blood cells (SAG-M), platelets and fresh frozen plasma to patients, with an increased bleeding risk who undergo open heart surgery, can be decreased with intra- and postoperative use of the cardioPAT® cell saver
Whether the percentage of patients receiving no transfusion (0 units) is increased with the use of a cardioPAT® cell saver
The cost-effectiveness of using the cardioPAT® cell saver compared with the current standard treatment
Hemoglobin and platelet count for the interventional group pre- and postoperatively, as well as at discharge and compare these with the control group
The composition and quality of the cardioPAT® red blood cell product
The composition of the cardioPAT® waste product
The length of stay in the ICU and total hospitalization after cardiac surgery
The impact on different aspects of coagulation
The extent of renal impairment in the postoperative period
The inflammatory response in the postoperative period
Endothelial injury in in the postoperative period
Sample size calculation:
The standard deviation, for blood transfusion to patients at the Department of Cardiothoracic Surgery, Rigshospitalet, was calculated to ±0,32.
From a clinical point of view a relevant reduction, which would justify a routine use of the CardioPAT® device, would be somewhere between 15-20%. This reduction would result in the Department saving every 1/7 to 1/5 unit of blood. Therefore a difference of 15% will be used for the power calculation.
Sample size was calculated by means of a "Sample Size Calculator" found online at: http://hedwig.mgh.harvard.edu/sample_size/size.html.This power analysis calculated that a total of 146 patients will need to enter this two-treatment parallel-design study. The probability (power) is 80% that the study will detect a treatment difference at a two-sided 0,05 significance level, based on the assumption that the standard deviation of the response variable is 0,32 and the true difference between treatments is set to 0,15 units (15%).
An interim analysis will be conducted after the inclusion of approximately 80 patients. If the results are relevant at this time, the study will stop inclusion here and present the results.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Aortic Stenosis, Aortic Insufficiency, Mitral Insufficiency, Aortic Aneurysm
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Title
Interventional group
Arm Type
Experimental
Arm Description
For patients in the interventional group we use a CardioPAT cell saver intra- and postoperatively.
Intervention Type
Device
Intervention Name(s)
cardioPAT cell saver
Primary Outcome Measure Information:
Title
The rate of allogenic transfusion with red blood cells (SAG-M)
Time Frame
The entire stay at the Department of Cardiothoracic Surgery, Rigshospitalet (approximately one week after surgery)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erika Nodin, MD
Organizational Affiliation
Department of Cardiothoracic Surgery, Rigshospitalet, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Cardiothoracic Surgery, Rigshospitalet
City
Copenhagen
State/Province
København Ø
ZIP/Postal Code
2100
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
The CardioPAT Project: A Randomized Trial
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