← Back to Clinical Trials
Recruiting Phase 4 NCT06511778

sTErnAl heMostasiS Trial

Trial Parameters

Condition Excessive Bleeding During Surgery
Sponsor WakeMed Health and Hospitals
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 60
Sex ALL
Min Age 21 Years
Max Age N/A
Start Date 2024-10-17
Completion 2026-08
Interventions
Hemoblast Bellows application

Brief 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.

Eligibility Criteria

Inclusion Criteria: * Patients are scheduled to undergo on-pump open chest cardiothoracic surgery. * Patients must be willing and able to provide written informed consent. * If the patient is of childbearing potential, they must have a negative pregnancy test within 24 hours of the index procedure. * Patients must be at least 21 years of age. * Patients have at least one of the following risk factors: 1. Undergoing redo sternotomy 2. Have a preoperative platelet count \<150 mg/dL 3. Are on dual antiplatelet therapy (blood thinners) \< 5 days prior to sternotomy 4. Have a BMI (body mass index)\> 35 5. Are undergoing combined CABG (coronary artery bypass surgery)/valve surgery 6. Have chronic kidney disease (GFR \<60 ml/min) or ESRD (end stage renal disease) Exclusion Criteria: * Patients who undergo thoracotomy approach * Patients who are not deemed an appropriate candidate by the investigator. * Patients who are pregnant or nursing, or who plan to become pregnant during the course of t

Related Trials