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

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.