Status:
RECRUITING
sTErnAl heMostasiS Trial
Lead Sponsor:
WakeMed Health and Hospitals
Collaborating Sponsors:
Dilon Technologies
Conditions:
Excessive Bleeding During Surgery
Eligibility:
All Genders
21+ years
Phase:
PHASE4
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-...
Detailed Description
This is a prospective randomized 1:1 trial to evaluate the efficacy of the application of HEMOBLASTTM during cardiothoracic surgery to reduce the increased risk of sternal bleeding in 30 treatment and...
Eligibility Criteria
Inclusion
- 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:
- Undergoing redo sternotomy
- Have a preoperative platelet count \<150 mg/dL
- Are on dual antiplatelet therapy (blood thinners) \< 5 days prior to sternotomy
- Have a BMI (body mass index)\> 35
- Are undergoing combined CABG (coronary artery bypass surgery)/valve surgery
- Have chronic kidney disease (GFR \<60 ml/min) or ESRD (end stage renal disease)
Exclusion
- 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 this study.
Key Trial Info
Start Date :
October 17 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06511778
Start Date
October 17 2024
End Date
September 1 2026
Last Update
September 11 2025
Active Locations (1)
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1
WakeMed Health and Hospitals
Raleigh, North Carolina, United States, 27610