Coronary Artery Disease Clinical 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
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06030596 -
SPECT Myocardial Blood Flow Quantification for Diagnosis of Ischemic Heart Disease Determined by Fraction Flow Reserve
|
||
Completed |
NCT04080700 -
Korean Prospective Registry for Evaluating the Safety and Efficacy of Distal Radial Approach (KODRA)
|
||
Recruiting |
NCT03810599 -
Patient-reported Outcomes in the Bergen Early Cardiac Rehabilitation Study
|
N/A | |
Recruiting |
NCT06002932 -
Comparison of PROVISIONal 1-stent Strategy With DEB Versus Planned 2-stent Strategy in Coronary Bifurcation Lesions.
|
N/A | |
Not yet recruiting |
NCT06032572 -
Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE)
|
N/A | |
Recruiting |
NCT05308719 -
Nasal Oxygen Therapy After Cardiac Surgery
|
N/A | |
Recruiting |
NCT04242134 -
Drug-coating Balloon Angioplasties for True Coronary Bifurcation Lesions
|
N/A | |
Completed |
NCT04556994 -
Phase 1 Cardiac Rehabilitation With and Without Lower Limb Paddling Effects in Post CABG Patients.
|
N/A | |
Recruiting |
NCT05846893 -
Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease
|
N/A | |
Recruiting |
NCT06027788 -
CTSN Embolic Protection Trial
|
N/A | |
Recruiting |
NCT05023629 -
STunning After Balloon Occlusion
|
N/A | |
Completed |
NCT04941560 -
Assessing the Association Between Multi-dimension Facial Characteristics and Coronary Artery Diseases
|
||
Completed |
NCT04006288 -
Switching From DAPT to Dual Pathway Inhibition With Low-dose Rivaroxaban in Adjunct to Aspirin in Patients With Coronary Artery Disease
|
Phase 4 | |
Completed |
NCT01860274 -
Meshed Vein Graft Patency Trial - VEST
|
N/A | |
Recruiting |
NCT06174090 -
The Effect of Video Education on Pain, Anxiety and Knowledge Levels of Coronary Bypass Graft Surgery Patients
|
N/A | |
Completed |
NCT03968809 -
Role of Cardioflux in Predicting Coronary Artery Disease (CAD) Outcomes
|
||
Terminated |
NCT03959072 -
Cardiac Cath Lab Staff Radiation Exposure
|
||
Recruiting |
NCT05065073 -
Iso-Osmolar vs. Low-Osmolar Contrast Agents for Optical Coherence Tomography
|
Phase 4 | |
Recruiting |
NCT04566497 -
Assessment of Adverse Outcome in Asymptomatic Patients With Prior Coronary Revascularization Who Have a Systematic Stress Testing Strategy Or a Non-testing Strategy During Long-term Follow-up.
|
N/A | |
Completed |
NCT05096442 -
Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please NEO in Korean Patients With Coronary De Novo Lesions
|
N/A |