Actively Recruiting
sTErnAl heMostasiS Trial
Led by WakeMed Health and Hospitals · Updated on 2025-09-11
60
Participants Needed
1
Research Sites
97 weeks
Total Duration
On this page
Sponsors
W
WakeMed Health and Hospitals
Lead Sponsor
D
Dilon Technologies
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
sTErnAl heMostasiS Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients scheduled for on-pump open chest cardiothoracic surgery
- Willing and able to provide written informed consent
- Negative pregnancy test within 24 hours before the procedure if of childbearing potential
- At least 21 years old
- Have at least one risk factor: redo sternotomy, platelet count below 150 mg/dL, dual antiplatelet therapy within 5 days, BMI over 35, combined CABG/valve surgery, or chronic kidney disease/end stage renal disease
You will not qualify if you...
- Patients undergoing thoracotomy approach
- Patients deemed inappropriate candidates by the investigator
- Pregnant or nursing patients or those planning pregnancy during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
WakeMed Health and Hospitals
Raleigh, North Carolina, United States, 27610
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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