Status
Conditions
Treatments
About
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.
Full 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:
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:
Exclusion criteria:
The aim of the study is to investigate:
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
68 participants in 2 patient groups
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal