drugset / Trial / NCT06511778
sTErnAl heMostasiS Trial
RandomizedParallel-groupSingle-blindPrevention
Summary
Sternal bleeding remains an unsolved problem for cardiac surgery teams costing operative time, blood loss, and distraction from the critical operative field. As such, the following is an investigator-initiated trial to determine whether application of a topical hemostatic agent reduces sternal bleeding during cardiac surgery using sternotomy approach.
Timeline
- Start
- 2024-10-17
- Primary completion
- 2026-08
- Completion
- 2026-09
Publications
- Background HEMOBLAST™ Bellows Hemostatic Agent [instructions for use]. Dilon Technologies, Inc.
- Background Now That's Real Stopping Powder [Information Brochure]. Dilon Technologies, Inc.
- Results Spotnitz WD, Zielske D, Centis V, Hoffman R, Gillen DL, Wittmann C, Guyot V, Campos DM, Forest P, Pearson A, McAfee PC. The SPOT GRADE: A New Method for Reproducibly Quantifying Surgical Wound Bleeding. Spine (Phila Pa 1976). 2018 Jun 1;43(11):E664-E671. doi: 10.1097/BRS.0000000000002447.
- Results Elassal AA, Al-Ebrahim KE, Debis RS, Ragab ES, Faden MS, Fatani MA, Allam AR, Abdulla AH, Bukhary AM, Noaman NA, Eldib OS. Re-exploration for bleeding after cardiac surgery: revaluation of urgency and factors promoting low rate. J Cardiothorac Surg. 2021 Jun 7;16(1):166. doi: 10.1186/s13019-021-01545-4.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Hemoblast Bellows | Unknown | — | Topical |
Indications
No indication recorded.