sTErnAl heMostasiS Trial
Recruiting
Phase 4
Interventional Study
Excessive Bleeding During Surgery
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 21 and older
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 60 (estimated)
- Sponsor
- WakeMed Health and Hospitals · Other
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About This Trial
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.
Trial Locations
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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.…
Contacts
No contact information available.