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
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:
1. Control group: undergo heart surgery with blood conserving strategies that are currently
standard routine at Rigshospitalet.
2. 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.
Study Type
Interventional
Primary Outcome
The rate of allogenic transfusion with red blood cells (SAG-M)
Condition
Coronary Artery Disease
Intervention
cardioPAT cell saver
Study Arms / Comparison Groups
Control group
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
68
Start Date
December 2013
Completion Date
December 2015
Primary Completion Date
December 2015
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)
Gender
All
Ages
18 Years - 100 Years
Accepts Healthy Volunteers
No
Contacts
Erika Nodin, MD, ,
Location Countries
Denmark
Location Countries
Denmark
Administrative Informations
NCT ID
NCT02058134
Organization ID
H-3-2013-169
Responsible Party
Principal Investigator
Study Sponsor
Rigshospitalet, Denmark
Study Sponsor
Erika Nodin, MD, Principal Investigator, Department of Cardiothoracic Surgery, Rigshospitalet, Denmark
Verification Date
August 2016