Pathogen reduced plasma products: a clinical practice scientific review from the AABB

Area of Science:

• Transfusion Medicine
• Blood Safety
• Pathogen Reduction Technology

Background:

• Limited literature exists on the efficacy and safety of pathogen-reduced (PR) plasma.
• Existing studies often suffer from low quality and small sample sizes.
• Varied methodologies complicate the assessment of therapeutic benefits and risks.

Purpose of the Study:

• To systematically review and grade the clinical trial evidence for pathogen-reduced plasma.
• To assess the safety and efficacy of pathogen inactivation in plasma transfusions.

Main Methods:

• A systematic literature review was conducted by an AABB committee.
• Clinical trial evidence was graded with the assistance of a GRADE expert.
• Included studies focused on solvent/detergent (S/D) and amotosalen PR plasma.

Main Results:

• Pathogen inactivation did not negatively impact the efficacy of S/D or amotosalen plasma transfusions across patient groups.
• No significant safety concerns were identified beyond package insert contraindications.
• The quality of most identified studies was low, with small sample sizes.

Conclusions:

• Current data suggest pathogen-reduced plasma is safe and effective, with no adverse impact on efficacy.
• Further large-scale, well-designed trials are necessary to comprehensively evaluate all PR plasma products.
• Continued research is crucial for optimizing blood safety and transfusion practices.