The FINISH-3 Trial
| Autor: | Linda A. Zuckerman, Grant V. Bochicchio, Paul Frohna, Roberto Troisi, Baki Topal, Piet Pattyn, Daniel L. Gillen, Robert J. Porte, Kenneth L. Renkens, Ian Chetter, NavYash Gupta, William Muir |
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| Přispěvatelé: | Groningen Institute for Organ Transplantation (GIOT) |
| Jazyk: | angličtina |
| Rok vydání: | 2015 |
| Předmět: |
Adult
Male Surgical Sponges medicine.medical_specialty Adolescent SURGERY Blood Loss Surgical MULTICENTER Fibrin Tissue Adhesive Kaplan-Meier Estimate Hemostatics Fibrin law.invention CLINICAL-TRIAL Young Adult Randomized controlled trial law medicine Humans Single-Blind Method Prospective Studies Prospective cohort study Aged Proportional Hazards Models Aged 80 and over Hemostat biology business.industry Hazard ratio FIBRIN SEALANT Soft tissue Middle Aged EFFICACY Hemostasis Surgical Surgery Clinical trial LIVER RESECTION Treatment Outcome ADHESIVES Hemostasis SAFETY biology.protein Gelatin Female business Follow-Up Studies |
| Zdroj: | Journal of the american college of surgeons, 220(1), 70-81. ELSEVIER SCIENCE INC |
| ISSN: | 1072-7515 |
| Popis: | This Phase 3, international, randomized, single-blind, controlled trial (FINISH-3) compared the efficacy and safety of Fibrocaps, a ready-to-use, dry-powder fibrin sealant containing human plasma-derived thrombin and fibrinogen, vs gelatin sponge alone for use as a hemostat for surgical bleeding in 4 indications (ie, spinal, hepatic, vascular, soft tissue dissection).Adults with mild to moderate surgical bleeding (randomized 2:1; Fibrocaps vs gelatin sponge) were treated at a single bleeding site (day 1). Time to hemostasis (TTH) during 5 minutes was compared (log-rank statistic) within each indication. Safety follow-up continued to day 29.Patients were treated (Fibrocaps, n = 480; gelatin sponge, n = 239) when undergoing spinal (n = 183), vascular (n = 175), hepatic (n = 180), or soft-tissue (n = 181) procedures. Fibrocaps was applied by spray device in 53% of all procedures (94% of hepatic and soft-tissue procedures). Fibrocaps significantly reduced TTH compared with gelatin sponge; estimated hazard ratios were 3.3, 2.1, 2.3, and 3.4 for the 4 surgical indications, respectively (each p0.001; primary end point). Fibrocaps significantly reduced median TTH for each indication (p0.001) and was superior for secondary efficacy end points of restricted mean TTH (p0.001) and probability of hemostasis at 3 (p0.001) and 5 (p ≤ 0.002) minutes. Adverse event incidences were generally similar between treatment arms. Non-neutralizing, anti-thrombin antibodies developed in 2% of Fibrocaps-treated and 3% of gelatin sponge-treated patients.Fibrocaps was well tolerated and significantly reduced TTH relative to gelatin sponge alone in all 4 surgical indications. These findings demonstrate the broad utility of Fibrocaps as a hemostatic agent for mild to moderate surgical bleeding. |
| Databáze: | OpenAIRE |
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