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.
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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