Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06358079
Status:
RECRUITING
Last Update Posted:
2024-04-10
First Post:
2024-03-27
Brief Title:
Re-infusion of Unwashed Shed Blood During Off-pump Surgery
Sponsor:
Damascus University
Organization:
Damascus University
Study Overview
Official Title:
Isolated Cardiotomy Circuit for Re-infusion of Unwashed Shed Blood During Off-pump Coronary Artery Surgery
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To assess the efficacy and side-effects of re-infusion of unwashed shed blood during off-pump coronary artery surgery using a novel cardiotomy circuit
Detailed Description:
Introduction Blood transfusion is often required during cardiac surgical operations and may be associated with known risks and complications Off-pump coronary artery surgery has been shown to be associated with reduced need for blood transfusion and cell-savers are widely used as an additional method for reducing blood transfusion demands
Auto-transfusion of unwashed suctioned blood intra-operatively is thought to increase the inflammatory response and infective complications but data related to this approach are scares
Aims
To assess the effects and benefits of using an isolated cardiotomy circuit for re-infusion of unwashed shed blood during off-pump surgery and compare it to the conventional no re-infusion technique Assessments will focus on
clinical outcome
transfusion requirements
inflammatory response
alveolararterial oxygen pressure gradients
cognitive status
cost-benefit
Study design A prospective study involving patients undergoing off-pump coronary artery bypass surgery Patients will be randomized to two groups an isolated cardiotomy circuit for re-infusion of unwashed shed blood will be used in group a and the conventional no re-infusion technique will be used in group b
Participants Patients undergoing off-pump coronary artery bypass surgery
Setting Damascus University Cardiac Surgery Hospital
Auto-transfusion of unwashed suctioned blood intra-operatively is thought to increase the inflammatory response and infective complications but data related to this approach are scares
Aims
To assess the effects and benefits of using an isolated cardiotomy circuit for re-infusion of unwashed shed blood during off-pump surgery and compare it to the conventional no re-infusion technique Assessments will focus on
clinical outcome
transfusion requirements
inflammatory response
alveolararterial oxygen pressure gradients
cognitive status
cost-benefit
Study design A prospective study involving patients undergoing off-pump coronary artery bypass surgery Patients will be randomized to two groups an isolated cardiotomy circuit for re-infusion of unwashed shed blood will be used in group a and the conventional no re-infusion technique will be used in group b
Participants Patients undergoing off-pump coronary artery bypass surgery
Setting Damascus University Cardiac Surgery Hospital
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None