sTErnAl heMostasiS Trial

Conditions

• Excessive Bleeding During Surgery

Eligibility Criteria

Sex

ALL

Age

21 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Hemoblast Bellows application — DRUG
  Hemoblast bellows is a hemostatic agent clinically proven effective on the validated SPOT GRADE scale for minimal, mild, and moderate bleeding. Patients will have the Hemoblast bellows applied during on pump sternotomy surgery.

Study Details

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.

Key Dates

Start date

Oct 17, 2024

Status verified

Sep 2025

Primary completion

Aug 31, 2026

Completion

Sep 30, 2026

Study Design

Enrollment

60 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• No Intervention: No Application of Hemoblast Hemostatic Agent
  Patients who are randomized to "control" will not receive application of the Hemoblast hemostatic agent during on pump sternotomy surgery.
• Active Comparator: Application of Hemoblast Hemostatic Agent
  Patients who are randomized to "treatment" will receive application of the Hemoblast hemostatic agent during on pump sternotomy surgery.

Primary Outcome Measure

Sternal Bleeding Score [ Time Frame: Sternotomy creation ]

Locations (1)

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