Improving Efficacy and Safety of Pathogen Inactivation Strategies for Platelet Transfusion in Cardiac Surgical Patients on Cardiopulmonary Bypass
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Cardiopulmonary Bypass Surgery
- Sponsor
- University of Maryland, Baltimore
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Change in Maximum Amplitude (MA) of thromboelastography (TEG)
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This is a prospective randomized clinical trial designed to determine the hemostatic ability of pathogen reduced platelet, when compared to non-pathogen reduced platelets suspended in platelet additive solution.
Detailed Description
The safety and efficacy of pathogen reduced (PRT) platelets (PLTs) have been investigated in several controlled clinical studies. Most of these clinical studies evaluated the efficacy of PRT PLTs during prophylactic transfusion evaluating post-transfusion platelet count increments, rather than platelet function during bleeding episodes. During massive transfusion events and immediate resuscitation, PLT transfusion is recognized as an important determinant of a positive patient outcome. PLT transfusion is important to control bleeding in patients undergoing cardiac surgery on cardiopulmonary bypass because cardiopulmonary bypass alters platelet function. Thus, transfusion of functional platelets is required to control bleeding post-operatively. In this context, the investigators propose to investigate whether efficient hemostasis associated with platelet transfusion differs with the use of pathogen reduced PRT PLTs compared to non-pathogen reduced PLTs that are suspended in platelet additive solution.
Investigators
Magali Fontaine
Professor of Pathology
University of Maryland, Baltimore
Eligibility Criteria
Inclusion Criteria
- •Age \> 18 years
- •Preoperative evaluation for risk of transfusion: platelet count \< 200,000/mcl, OR anticipated time on cardiopulmonary bypass \> 90 min, OR complex cardiac surgery, OR use of preoperative antiplatelet therapy within 3-5 days of surgery.
Exclusion Criteria
- •Patient that lack the ability to consent
- •Patients with the diagnosis of idiopathic thrombocytopenia purpura,
- •Patient with the diagnosis of heparin-induced thrombocytopenia.
Outcomes
Primary Outcomes
Change in Maximum Amplitude (MA) of thromboelastography (TEG)
Time Frame: within 60 minutes including blood for TEG testing immediately pre transfusion and blood draw post transfusion
ΔMA observed with platelet transfusion (difference in MA measured within an hour post transfusion to MA measured immediately pre-transfusion)
Secondary Outcomes
- Chest Tube Drainage(24 hours)
- Red blood cell units Transfused(Within the first 24 Hrs Following Surgery)
- Plasma Units Transfused(Within the first 24 Hrs Following Surgery)
- Platelet Units Transfused(Within the first 24 Hrs Following Surgery)
- Cryoprecipitate Units Transfused(Within the first 24 Hrs Following Surgery)