A prospective randomized open-label study that will evaluate the effectiveness of the pliable and absorbable bone hemostats (BoneSeal®) on the reduction of bleeding from the sternal bone marrow in patients undergoing cardiothoracic surgery.
Age range
45 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Ease of Use
Timeframe: The time frame for assessing the ease of product application is the short interval a the conclusion of the operation when we are applying the topical hemostatic agent to the sternal bone marrow. In other words at the end of the case, this takes <10 min.
Number of Participants Experiencing Re-bleed
Timeframe: 0-3 hours
Hemoglobin
Timeframe: Pre-operative (baseline) and Post-operative (3-6 hours after baseline)
Intra-operative Blood Units
Timeframe: 0-3 hours
Surgical Site Drainage
Timeframe: 6, 12, 18 and 24 hours
Number of Participants With Post Operative Complications Related to the Device
Timeframe: 30 days
Number of Participants Requiring Use of Another Product During Surgery
Timeframe: During surgery, up to 3 hours
End of Surgery Bleeding
Timeframe: End of surgery (closure of the chest)
Post-operative Blood Units
Timeframe: 3-24 hours
Number of Participants With Infection
Timeframe: 30 days