Safety and Hemostatic Effectiveness of the Fibrin Pad for Severe Soft-Tissue Bleeding During Abdominal, Retroperitoneal, Pelvic, and Thoracic (Non-cardiac) Surgery: A Randomized, Controlled, Superiority Trial
| Autor: | Bababhai Patel, Jonathan B. Koea, James Hart, O. James Garden, Jonathan Batiller, Jessica Shen, Craig P. Fischer, Peter Baldwin, Jeff R. Hammond, Axel Arnaud |
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| Rok vydání: | 2015 |
| Předmět: |
Adult
Male medicine.medical_specialty Thoracic Surgical Procedure Fibrin Tissue Adhesive Pelvis law.invention Randomized controlled trial law Abdomen medicine Humans Retroperitoneal Space Aged 80 and over Hemostat business.industry Middle Aged Thoracic Surgical Procedures Vascular surgery Hemostasis Surgical Cardiac surgery Surgery Treatment Outcome Cardiothoracic surgery Anesthesia Hemostasis Female Patient Safety business Abdominal surgery |
| Zdroj: | World Journal of Surgery. 39:2663-2669 |
| ISSN: | 1432-2323 0364-2313 |
| Popis: | In surgery, rapid hemostasis can be required in various settings and bleeding intensities to minimize complications related to blood loss. While effective hemostats are available for mild-to-moderate surgical bleeding, few are effective against challenging severe hemorrhage. We report the effectiveness and safety of the fibrin pad (FP), a novel combination hemostat (device/human biologic), in controlling severe soft-tissue bleeding as compared to the standard of care (SoC).This randomized, controlled, superiority study enrolled subjects ≥18 years, requiring elective abdominal, retroperitoneal, pelvic, or thoracic (non-cardiac) surgery. A severe target bleeding site (TBS) was identified intra-operatively following which, subjects were randomized to the FP or the SoC group. Hemostatic status was observed at 4 min (primary endpoint) and 10 min post-randomization. Safety variables included TBS-related bleeding and thrombotic events.At 4 min post-randomization, 50/59 (84.7 %) subjects in the FP group and 10/32 (31.3%) [Corrected] subjects in the SoC group achieved hemostasis without needing re-treatment (P0.0001). Compared to the SoC group, the FP group showed better hemostasis at 10 min post-randomization [58/59 (98.3 %) vs. 28/32 (87.5 %); P = 0.01], lower mean time to hemostasis (6.1 ± 13.5 vs. 17.8 ± 32.0 min), and a less frequent need for re-treatment (5.1 vs. 53.1 %). The triangular test for binary response demonstrated the FP to be superior to SoC (95 % CI 1.474-3.290; P0.0001). Safety profiles in both groups were similar to those typically observed after long-duration surgery.The FP is safe and superior to SoC for controlling challenging severe soft-tissue bleeding encountered during intra-abdominal and thoracic surgical procedures. |
| Databáze: | OpenAIRE |
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