Phase 3, randomized, double-blind study of plasma-derived human thrombin versus bovine thrombin in achieving hemostasis in patients undergoing surgery
| Autor: | Cataldo Doria, James Hart, P. Mark Li, Craig P. Fischer, Christopher G. Wood, Steven W. Marra |
|---|---|
| Rok vydání: | 2008 |
| Předmět: |
Male
medicine.medical_specialty Thrombin Time Blood Loss Surgical Postoperative Hemorrhage Thrombin time Hemostatics Neurosurgical Procedures Perioperative Care law.invention Thrombin Double-Blind Method Randomized controlled trial law medicine Animals Humans Prospective Studies Seroconversion Intraoperative Complications Prospective cohort study Absorbable gelatin sponge medicine.diagnostic_test business.industry Cardiovascular Surgical Procedures General Medicine Length of Stay Middle Aged Hemostasis Surgical Surgery Clinical trial Anesthesia Hemostasis Cattle Female business medicine.drug |
| Zdroj: | Current Medical Research and Opinion. 24:785-794 |
| ISSN: | 1473-4877 0300-7995 |
| DOI: | 10.1185/030079908x273426 |
| Popis: | To compare the effectiveness of plasma-derived human thrombin and bovine thrombin for achieving hemostasis during surgery.Adults (N = 305) withor = 1 mild or moderate bleeding site not manageable by conventional modalities during elective cardiovascular, neurologic, or general surgical procedures at multiple study centers were randomized to human (n = 153) or bovine (n = 152) thrombin, applied topically with an absorbable gelatin sponge. Bleeding was assessed 3, 6, and 10 min post-application. Other evaluations included laboratory assessments, vital signs, blood loss, blood transfusions, time in specialty-care units, procedure duration, and length of hospital stay. Blood samples for antibody assessment were collected at baseline and postoperative week 5.The proportion of patients achieving hemostasis within 10 min (primary outcome) was equivalent for human and bovine thrombin (97.4 vs. 97.4%, respectively; ratio, 1.00; 95% CI, 0.96-1.05). The proportions of patients achieving hemostasis at 6 min (94.8 vs. 92.8%) and 3 min (73.2 vs. 72.4%) were also equivalent. No clinically meaningful differences were noted for other variables. The products had similar adverse event profiles. More patients (12.7%) who received bovine thrombin demonstrated seroconversion foror = 1 of the 4 antibodies assayed than patients who received human thrombin (3.3%). No patients in the human thrombin group developed seroconversion for anti-human thrombin or anti-human factor V/Va antibodies. Limitations of this study include the lack of a placebo-control group, the potential for inter-surgeon variability, and the fact that antibody assessment was not evaluable in all patients.Plasma-derived human thrombin and bovine thrombin were equivalent in achieving hemostasis within 10, 6, and 3 min and had comparable safety profiles. None of the patients receiving human thrombin developed seroconversion for antibodies to any of the human antigens. |
| Databáze: | OpenAIRE |
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