Cardiopulmonary Bypass Surgery
Conditions
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.
Interventions
BIOLOGICALPlatelet transfusion
platelet administration through intravenous access
Sponsors
University of Maryland, Baltimore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Maximum Amplitude (MA) of thromboelastography (TEG) | 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
| Measure | Time frame | Description |
|---|---|---|
| Chest Tube Drainage | 24 hours | The volume in ml of chest tube drainage during the first 24 hours post surgery |
| Red blood cell units Transfused | Within the first 24 Hrs Following Surgery | number of red blood cell units transfused |
| Platelet Units Transfused | Within the first 24 Hrs Following Surgery | number of platelet units transfused |
| Cryoprecipitate Units Transfused | Within the first 24 Hrs Following Surgery | number of Cryoprecipitate Units Transfused |
| Plasma Units Transfused | Within the first 24 Hrs Following Surgery | number of plasma units transfused |
Countries
United States
Outcome results
None listed