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New treatment option for Excessive Bleeding During Surgery
Official title sTErnAl heMostasiS Trial
ClinicalTrials.gov ID: NCT06511778
What this study is testing
What is Hemoblast Bellows application?
Hemoblast Bellows application is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for excessive bleeding during surgery.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 and older
You may be able to join if
- 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:
You likely can't join if
- 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.
See the full eligibility 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:
- 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)
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Raleigh, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Raleigh, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.