- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02058134
The CardioPAT Project: A Randomized Trial
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
København Ø
-
Copenhagen, København Ø, Denmark, 2100
- Department of cardiothoracic surgery, Rigshospitalet
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: Control group
|
|
EXPERIMENTAL: Interventional group
For patients in the interventional group we use a CardioPAT cell saver intra- and postoperatively.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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)
|
The entire stay at the Department of Cardiothoracic Surgery, Rigshospitalet (approximately one week after surgery)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Erika Nodin, MD, Department of Cardiothoracic Surgery, Rigshospitalet, Denmark
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Aortic Valve Disease
- Heart Valve Diseases
- Ventricular Outflow Obstruction
- Coronary Disease
- Aortic Diseases
- Coronary Artery Disease
- Aortic Valve Stenosis
- Mitral Valve Insufficiency
- Aortic Valve Insufficiency
- Aneurysm
- Aortic Aneurysm
Other Study ID Numbers
- H-3-2013-169
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Coronary Artery Disease
-
Fundación EPICActive, not recruitingCoronary Artery Disease | Left Main Coronary Artery Disease | Left Main Coronary Artery Stenosis | Restenosis, CoronarySpain
-
Elixir Medical CorporationIstituto Clinico HumanitasActive, not recruitingCoronary Artery Disease | Chronic Total Occlusion of Coronary Artery | Multi Vessel Coronary Artery Disease | Bifurcation of Coronary Artery | Long Lesions Coronary Artery DiseaseItaly
-
Peking Union Medical College HospitalRecruitingCoronary Artery Disease | Inflammation | Coronary Artery Disease Progression | Coronary Artery Stenosis | Coronary Artery Restenosis | Inflammatory Disease | Inflammation VascularChina
-
Peking Union Medical College HospitalNot yet recruitingCoronary Artery Disease | Inflammation | Coronary Artery Disease Progression | Coronary Artery Stenosis | Coronary Artery Restenosis | Inflammatory Disease | Inflammation VascularChina
-
IGLESIAS Juan FernandoUniversity of BernNot yet recruiting
-
National Institutes of Health Clinical Center (CC)National Heart, Lung, and Blood Institute (NHLBI)CompletedCoronary Arteriosclerosis | Coronary Artery Disease (CAD) | Obstructive Coronary Artery DiseaseUnited States
-
Barts & The London NHS TrustImperial College London; Brunel UniversityNot yet recruitingCORONARY ARTERY DISEASE
-
Fundación EPICRecruitingCoronary Artery Disease | Coronary Disease | Coronary Occlusion | Left Main Coronary Artery Disease | Coronary Artery StenosisSpain
-
Abbott Medical DevicesCompletedCoronary Artery Disease | Coronary Disease | Coronary Occlusion | Chronic Total Occlusion of Coronary Artery | Coronary Restenosis | Coronary Artery Stenosis | Coronary Artery RestenosisBelgium
-
Seung-Jung ParkCardioVascular Research Foundation, KoreaRecruitingCoronary Stenosis | Coronary Artery Bypass Grafting | Coronary Artery Disease Progression | Percutaneous Coronary RevascularizationKorea, Republic of
Clinical Trials on cardioPAT cell saver
-
University Medical Center GroningenTerminated
-
Rigshospitalet, DenmarkDanish Heart Foundation; Copenhagen Hospital CorporationTerminatedSystemic Inflammatory Response Syndrome | Coronary ArteriosclerosisDenmark
-
Rothman Institute OrthopaedicsUnknownOne-stage Bilateral Total Hip ReplacementUnited States
-
Norton Leatherman Spine CenterUnknownLow Back Pain Unresponsive to Non-surgical CareUnited States
-
University of RochesterCompleted
-
Cardiochirurgia E.H.Completed
-
The University of Texas Health Science Center,...Active, not recruitingMortality | Cardiac Surgery | Cardiopulmonary Bypass | Cardiac Disease | Arrythmia, Cardiac | Platelet TransfusionUnited States
-
University of MalayaCompletedAdolescent Idiopathic ScoliosisMalaysia
-
Sanquin Research & Blood Bank DivisionsZonMw: The Netherlands Organisation for Health Research and Development; Roche... and other collaboratorsCompleted
-
Royan InstituteCompletedBone CystIran, Islamic Republic of