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OpenTrials
Completed

NCT Number: NCT06535360

Efficacy of Pathogen Inactivation Strategies for Platelet Transfusion

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Platelet Transfusion

Biological

platelet administration through intravenous access

Primary outcomes

  1. 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

  1. Chest Tube Drainage

    Time frame: 24 hours

    The volume in ml of chest tube drainage during the first 24 hours post surgery

  2. Red blood cell units Transfused

    Time frame: Within the first 24 Hrs Following Surgery

    number of red blood cell units transfused

  3. Platelet Units Transfused

    Time frame: Within the first 24 Hrs Following Surgery

    number of platelet units transfused

  4. Cryoprecipitate Units Transfused

    Time frame: Within the first 24 Hrs Following Surgery

    number of Cryoprecipitate Units Transfused

  5. Plasma Units Transfused

    Time frame: Within the first 24 Hrs Following Surgery

    number of plasma units transfused

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Registry information

Official study title

Improving Efficacy and Safety of Pathogen Inactivation Strategies for Platelet Transfusion in Cardiac Surgical Patients on Cardiopulmonary Bypass

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Aug 2, 2024
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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