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Prothrombin complex concentrate vs. fresh frozen plasma in adult patients undergoing heart surgery - a pilot randomised controlled trial (PROPHESY trial)

Blizard Institute, Barts and the London School of Medicine, Queen Mary University of London, London, UK. NHS Blood and Transplant, London, UK. Department of Haematology, Barts Health NHS Trust, London, UK. Department of Cardiac Surgery, Barts Health NHS Trust, London, UK. William Harvey Research Institute, Barts and the London School of Medicine, Queen Mary University of London, London, UK. Department of Anaesthesia, Manchester Royal Infirmary, Manchester, UK. Systematic Review Initiative, NHS Blood and Transplant, Oxford, UK. Department of Anaesthesia, University Hospital Southampton, Southampton, UK. Department of Anaesthesia and Intensive Care, Royal Papworth Hospital, Cambridge, UK. NHS Blood and Transplant, Oxford, UK. Department of Haematology, Oxford University Hospitals NHS Foundation Trust, Oxford, UK. Department of Anaesthesia, Barts Health NHS Trust, London, UK. Outcomes Research Consortium, Cleveland Clinic, OH, USA.

Anaesthesia. 2020
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PICO Summary

Population

Cardiac surgery patients who developed bleeding within 24 hours of surgery (n= 50).

Intervention

Prothrombin complex concentrate (n= 25).

Comparison

Fresh frozen plasma (n= 25).

Outcome

There were 137 adverse events (75 prothrombin complex concentrate vs. 62 fresh frozen plasma) and 18 serious adverse events (5 prothrombin complex concentrate vs. 13 fresh frozen plasma). There was no increase in thromboembolic events with prothrombin complex concentrate. At 1 h after administration of the intervention there was a significant increase in fibrinogen, Factor V, Factor XII, Factor XIII, α(2) -antiplasmin and antithrombin levels in the fresh frozen plasma arm, while Factor II and Factor X were significantly higher in the prothrombin complex concentrate group. At 24 h, there were no significant differences in clotting factor levels.
Abstract
There is equipoise regarding the use of prothrombin complex concentrate vs. fresh frozen plasma in bleeding patients undergoing cardiac surgery. We performed a pilot randomised controlled trial to determine the recruitment rate for a large trial, comparing the impact of prothrombin complex concentrate vs. fresh frozen plasma on haemostasis (1 h and 24 h post-intervention), and assessing safety. Adult patients who developed bleeding within 24 h of cardiac surgery that required coagulation factor replacement were randomly allocated to receive prothrombin complex concentrate (15 IU.kg(-1) based on factor IX) or fresh frozen plasma (15 ml.kg(-1) ). If bleeding continued after the first administration of prothrombin complex concentrate or fresh frozen plasma administration, standard care was administered. From February 2019 to October 2019, 180 patients were screened, of which 134 (74.4% (95%CI 67-81%)) consented, 59 bled excessively and 50 were randomly allocated; 25 in each arm, recruitment rate 35% (95%CI 27-44%). There were 23 trial protocol deviations, 137 adverse events (75 prothrombin complex concentrate vs. 62 fresh frozen plasma) and 18 serious adverse events (5 prothrombin complex concentrate vs. 13 fresh frozen plasma). There was no increase in thromboembolic events with prothrombin complex concentrate. No patient withdrew from the study, four were lost to follow-up and two died. At 1 h after administration of the intervention there was a significant increase in fibrinogen, Factor V, Factor XII, Factor XIII, α(2) -antiplasmin and antithrombin levels in the fresh frozen plasma arm, while Factor II and Factor X were significantly higher in the prothrombin complex concentrate group. At 24 h, there were no significant differences in clotting factor levels. We conclude that recruitment to a larger study is feasible. Haemostatic tests have provided useful insight into the haemostatic changes following prothrombin complex concentrate or fresh frozen plasma administration. A definitive trial is needed to ascertain the benefits and safety for each.
Study details
Language : eng
Credits : Bibliographic data from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine