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.

Universal solvent/detergent-treated fresh frozen plasma (Uniplas--rationale and clinical properties.

Transfusions with incompatible blood products including plasma are a well-known problem. The present study was performed to test the effects of Uniplas, universal plasma that can be transfused regardless of a patient's blood group, with respect to bleeding and hemostatic activity. The study comprised 84 adult patients scheduled for elective openheart surgery. A total of 55 patients received plasma transfusions, while 29 patients not requiring plasma served as controls. If plasma transfusion was indicated during operation or over the two following days, patients were randomised 2:1 to receive Uniplas or Octaplas of blood group AB. Relevant clinical observations were recorded and blood tests taken repeatedly. The transfused patient groups were comparable, and no significant differences were observed with respect to activated clotting time (ACT), activated partial thromboplastin time (APTT) or postoperative bleeding into chest drains. The median number of transfused units of Uniplas was 3, with a range of 1-23, while the median for Octaplas was 2 with a range of 1-11. These differences were not significant.Thus, Uniplas has a similar effect as Octaplas in the treatment of bleeding in patients undergoing openheart surgery. Uniplas can therefore substitute for Octaplas and eliminate the risk of ABO-incompatible transfusions.