Study design

RECOTHROM Phase 3 Clinical Trial: Study Design Schematic

  • Randomized, double-blind, Phase 3 study, 411 patients at 34 US study sites undergoing spinal, vascular, or liver surgery received either RECOTHROM (1000 units/mL) or bovine thrombin* (1000 units/mL) in combination with an absorbable gelatin sponge, USP1
  • The primary efficacy endpoint was the incidence of hemostasis within 10 minutes. Secondary endpoints included incidence and severity of adverse events, incidence and grade of clinical laboratory abnormalities, and incidence of antibody production to either product. Patients were monitored for 1 month following the surgical procedure

*The bovine thrombin used throughout the study was Thrombin-JMI® marketed by King Pharmaceuticals.

REFERENCES:
1. Chapman WC, Singla N, Genyk Y, et al. A phase 3, randomized, double-blind comparative study of the efficacy and safety of topical recombinant human thrombin and bovine thrombin in surgical hemostasis. J Am Coll Surg. 2007;205:256-265.





Comparable efficacy to bovine thrombin, based on time to hemostasis within 10 minutes

In the largest pivotal clinical trial for a thrombin-containing topical hemostat, RECOTHROM was proven to effectively control diffuse bleeding and oozing across a range of surgical procedures

RECOTHROM Phase 3 study

Cumulative incidence of hemostasis over time

Efficacy compared to bovine thrombin in prespecified surgical procedures in Phase 3 study

Incidence of hemostasis achieved within 10 minutes

95% hemostasis was achieved overall within 10 minutes for both recombinant human thrombin and bovine thrombin (primary efficacy analysis).

*Spinal surgery procedures include: discectomy, corpectomy, laminectomy, cervical fusion.