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PRT PLTs stored in PAS for Cardiopulmonary Bypass
Phase 4
Waitlist Available
Led By Magali Fontaine, MD, PhD
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 60 minutes including blood for teg testing immediately pre transfusion and blood draw post transfusion
Awards & highlights
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 60 minutes including blood for teg testing immediately pre transfusion and blood draw post transfusion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 60 minutes including blood for teg testing immediately pre transfusion and blood draw post transfusion
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Maximum Amplitude (MA) of thromboelastography (TEG)
Secondary study objectives
Chest Tube Drainage
Cryoprecipitate Units Transfused
Plasma Units Transfused
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: PRT PLTs stored in PASExperimental Treatment1 Intervention
FDA approved and already used in this patient population tested for non-inferiority
Group II: Non-PRT PLTs stored in platelet additive solution (PAS)Active Control1 Intervention
FDA approved and already used in this patient population
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Platelet transfusion
2010
Completed Phase 4
~630
Find a Location
Who is running the clinical trial?
University of Maryland, BaltimoreLead Sponsor
705 Previous Clinical Trials
378,310 Total Patients Enrolled
Magali Fontaine, MD, PhDPrincipal InvestigatorUniversity of Maryland, Baltimore
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