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Published on: November 24, 2014
Prospective, multicenter, randomized, controlled trial evaluating the performance of a novel combination powder vs
Nicholas C Dang1, Abbas Ardehali2, Brian A Bruckner3
1Department of Surgery, Kaiser Moanalua Medical Center, Honolulu, Hawaii.
Insights
A novel combination powder (CP) demonstrated superior hemostatic performance compared to a hemostatic matrix (HM) in cardiothoracic surgery. CP achieved significantly faster hemostasis, proving its effectiveness in critical surgical scenarios.
Area of Science:
- Cardiothoracic Surgery
- Surgical Hemostasis
- Biomaterials in Medicine
Background:
- Effective hemostasis is crucial in cardiothoracic operations to minimize blood loss and improve patient outcomes.
- Existing hemostatic agents have limitations in achieving rapid and reliable bleeding control.
- A novel combination powder (CP) was developed to address these challenges.
Purpose of the Study:
- To compare the hemostatic performance of a novel combination powder (CP) against a control hemostatic matrix (HM).
- To evaluate the efficacy of CP in achieving hemostasis during cardiothoracic procedures.
- To assess the time to hemostasis as a primary and secondary endpoint.
Main Methods:
- A multicenter, randomized, controlled trial was conducted with 105 subjects undergoing cardiothoracic operations.
- Subjects were intraoperatively randomized to receive either CP or HM.
- The primary endpoint was total time to hemostasis (TTTH) at 3 minutes; a secondary endpoint was TTTH at 5 minutes.
Main Results:
- The CP group achieved significantly higher rates of hemostasis within 3 minutes (64.2%) compared to the HM group (9.6%) (P < .001).
- Hemostasis at 5 minutes was also significantly higher in the CP group (92.5%) versus the HM group (44.2%) (P < .001).
- No device-related adverse events were reported for either CP or HM.
Conclusions:
- The novel combination powder (CP) demonstrated superiority over the hemostatic matrix (HM) in achieving hemostasis within 3 minutes.
- CP also showed noninferiority for hemostasis at 5 minutes, indicating robust and reliable bleeding control.
- These findings support CP as an effective option for hemostasis in cardiothoracic surgery.
Aim:
This trial compared the hemostatic performance of a novel combination powder (CP) to a control hemostatic matrix (HM) in cardiothoracic operations.
Methods:
Patients meeting eligibility criteria were enrolled after providing informed consent. Subjects were randomized intraoperatively to receive CP (HEMOBLAST Bellows; Biom'up, France) or HM (FLOSEAL Hemostatic Matrix; Baxter Healthcare Corporation, Hayward, CA). Bleeding was assessed using a clinically validated, quantitative bleeding severity scale. The primary endpoint was total time to hemostasis (TTTH), from the start of device preparation, as an indicator of when a surgeon asks for a surgical hemostat until hemostasis was achieved. TTTH at 3 minutes was utilized for the primary analysis, while TTTH at 5 minutes was considered as a secondary endpoint.
Results:
A total of 105 subjects were enrolled across four institutions. The primary efficacy endpoint for the superiority of CP relative to HM for success at achieving hemostasis within 3 minutes was met, with 64.2% of the CP group achieving hemostasis compared with 9.6% of the HM group, a difference of 54.54% (37.4%-71.6%; P < .001 for superiority). The secondary efficacy endpoint was also met, with 92.5% of the CP group achieving hemostasis at 5 minutes versus 44.2% in the HM group, a difference of 48.2% (31.1%-65.4%; P < .001 for noninferiority). There were no device-related adverse events.
Conclusions:
In this multicenter, randomized, controlled trial, comparison of CP to HM revealed CP superiority and noninferiority for TTTH at 3 and 5 minutes, respectively.
