Publication Date
6-1-2024
Journal
Surgery Open Science
DOI
10.1016/j.sopen.2024.04.009
PMID
38800121
PMCID
PMC11127167
PubMedCentral® Posted Date
5-3-2024
PubMedCentral® Full Text Version
Post-print
Published Open-Access
yes
Keywords
Cardiac surgery, General surgery, Hemostasis, Hemostatic agent, Intraoperative bleeding polysaccharide, Postoperative bleeding, Urologic surgery
Abstract
BACKGROUND: Operative blood loss is associated with postoperative morbidity and mortality in surgery. Hemostatic agents are used as adjuncts for hemostasis during surgery and help to prevent postoperative bleeding. We evaluated the safety and efficacy of an investigational polysaccharide hemostatic (PH) topical product compared to a U.S. Food and Drug Administration (FDA)-approved control in clinical use comprising microporous polysaccharide hemospheres (MPH) to achieve hemostasis of bleeding surfaces during surgery.
STUDY DESIGN: This prospective multicenter trial enrolled patients undergoing open elective cardiac, general, or urologic surgery. Patients were stratified by bleeding severity and therapeutic area, then randomized 1:1 to receive PH or MPH. Bleeding assessments occurred intraoperatively using a novel bleeding assessment methodology. Primary endpoint was noninferiority as compared with control via effective hemostasis at 7 min. Patients were monitored and followed daily in the postoperative period until time of discharge and again at 6 weeks. Overall survival was assessed in oncology patients at 24 months. Safety of PH vs. MPH was determined by comparing relative incidence of adverse events.
RESULTS: Across 19 centers, 324 (161 PH, 163 MPH) patients were randomized (48 % general surgery, 27 % cardiac surgery, and 25 % urologic surgery). PH was noninferior to MPH and met the primary endpoint of hemostatic success at 7 min at a non-inferiority margin of 10 %. No significant differences were found in adverse event rates. Six deaths were reported within the 6-week follow-up period. No difference in overall survival was observed at 2 years (76 % PH vs. 74 % MPH,
CONCLUSION: Across three therapeutic areas, PH was noninferior to MPH at all hemostasis assessment time points with no safety concerns. PH is an effective alternative to MPH for hemostasis during surgery.
ClinicalTrials.gov Identifier: NCT02359994
Graphical Abstract
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Cardiology Commons, Diseases Commons, Hematology Commons, Medical Sciences Commons, Mental and Social Health Commons, Surgery Commons