A refined clotting agent may be changing the way surgeons manage bleeding on the operating table.
A newly developed human fibrinogen concentrate significantly reduced surgical blood loss and demonstrated a favorable safety profile compared with standard blood products in patients undergoing major spinal or abdominal surgery, according to a large, randomized trial.
Led by Niels Rahe-Meyer of Franziskus Hospital Bielefeld in Germany, the researchers evaluated human fibrinogen concentrate (FC) against fresh frozen plasma (FFP) or cryoprecipitate (Cryo) in adults who experienced clinically significant bleeding during elective operations. It aimed to determine whether FC could serve as an effective first-line treatment for fibrinogen deficiency, which is a common complication in major surgery.
A total of 222 patients were enrolled at 15 hospitals in Europe and the United Kingdom. About half (n = 110) received FC and the other 112 were treated with FFP or Cryo, depending on the type of surgery. The trial focused on procedures that are known for substantial blood loss, including spinal surgeries and cytoreductive surgery for pseudomyxoma peritonei, a rare abdominal malignancy.
The primary outcome was intraoperative blood loss from the time of treatment initiation to the end of surgery with a noninferiority margin of 150 mL. Patients in the FC group had a mean blood loss of 1381 mL, whereas patients in the FFP/Cryo group had 1660 mL mean blood loss. The 279 mL difference met the prespecified margin for noninferiority. A posthoc analysis showed a statistically significant advantage for FC.
FC-treated patients also achieved target fibrinogen levels more rapidly. Within 15 minutes of treatment, 55% of FC recipients had corrected levels, vs 18% in the FFP/Cryo group. Correction failed entirely in 19% of the FC group and 56% of the FFP/Cryo group.
Rebleeding occurred in 5 patients in the FFP/Cryo group and none in the FC group. Postoperative blood loss, transfusion requirements, and hospital length of stay were comparable between groups.
The incidence of thromboembolic events (TEEs), including deep vein thrombosis and pulmonary embolism, was lower in the FC group—4% vs 12% in the FFP/Cryo group. No treatment-related deaths were reported. One patient in the FFP/Cryo group died of respiratory failure, which was deemed unrelated to the intervention.
FC was administered more quickly than FFP or Cryo. The median time from treatment decision to infusion start was 33 minutes for FC and 67 minutes for FFP/Cryo. FC infusion took a median of 5 minutes, compared with 23 minutes for FFP or Cryo.
The researchers concluded that FC is an effective option for managing bleeding in high-risk surgical patients. "Given the diverse range of surgical interventions and sources of bleeding included, the trial's results have broad applicability to all types of surgery with a high bleeding risk and trauma," they wrote.
Full disclosures can be found in the published study.
Source: eClinicalMedicine
