Clinical trial NCT06535360: Efficacy of Pathogen Inactivation Strategies for Platelet Transfusion
Official title: Improving Efficacy and Safety of Pathogen Inactivation Strategies for Platelet Transfusion in Cardiac Surgical Patients on Cardiopulmonary Bypass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cardiopulmonary Bypass Surgery
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2024-08-02
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Maximum Amplitude (MA) of thromboelastography (TEG)
timeFrame: within 60 minutes including blood for TEG testing immediately pre transfusion and blood draw post transfusion
Secondary outcomes:
measure: Chest Tube Drainage
timeFrame: 24 hours
measure: Red blood cell units Transfused
timeFrame: Within the first 24 Hrs Following Surgery
measure: Platelet Units Transfused
timeFrame: Within the first 24 Hrs Following Surgery
measure: Cryoprecipitate Units Transfused
timeFrame: Within the first 24 Hrs Following Surgery
measure: Plasma Units Transfused
timeFrame: Within the first 24 Hrs Following Surgery
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
Study officials:
affiliation: University of Maryland, Baltimore
name: Magali Fontaine, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: