Universal fresh frozen plasma (Uniplas): a safe product in open-heart surgery

Abstract

Objective: To test the tolerability and safety of the universal plasma Uniplas [solvent/detergent (SD)-treated plasma], infused regardless of the patient's blood group.

Design: Prospective, parallel group, controlled and observer-blinded study, randomized with respect to patients requiring plasma transfusion.

Setting: Cardiothoracic operating room and ICU in a university hospital.

Patients: Eighty-four patients undergoing open-heart surgery comparing three parallel treatment groups and one control group.

Interventions: The Uniplas treatment group was subdivided into patients with blood group A, B or AB, and group O. The treatment group receiving Octaplas of type AB, was not subdivided. Patients who did not require any plasma transfusion served as control.

Measurements: Complement activation (C3bc, TCC), direct antiglobulin test (DAT) and other immunohaematological tests, tests for haemolysis, and relevant clinical observations during treatment phase. Blood samples were collected again after 6 months for evaluation of viral safety.

Results: Of the 84 patients, 29 served as control group. Uniplas was transfused in 36 of the patients (1-23 units). Octaplas was transfused in 19 patients (1-11 units). During the study no clinical adverse events related to plasma transfusion were observed. The degree of complement activation C3bc and TCC, a recommended test for biocompatibility, did not show any increased activation after Uniplas or Octaplas transfusion. No haemolytic reactions, positive DAT-tests or viral transmissions were observed after Uniplas transfusion.

Conclusion: In open-heart surgery, Uniplas, which can be transfused regardless of a patient's blood group, was well-tolerated and gave no adverse drug reactions.