Clinical trial NCT03085017: Effectiveness of BoneSeal® on Bone Hemostats in Patients Undergoing Cardiothoracic Surgery
Official title: Effectiveness of BoneSeal® on Bone Hemostats in Patients Undergoing Cardiothoracic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Bypass Grafting
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2017-03-21
Enrollment: 57
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed description: A prospective randomized open-label study that will evaluate the effectiveness of the pliable and absorbable bone hemostats (BoneSeal®) composed of synthetic materials and hydroxyapatite on the reduction of bleeding from the sternal bone marrow in patients undergoing Coronary Artery Bypass Grafting, with or without valve replacement or repair. This product will be compared to the similar, currently used product, Ostene®. Bleeding will be evaluated qualitatively by the surgeon as well as quantitatively by comparing pre- and post-operative hemoglobin levels, intra-operative and post-operative blood product usage, and post-operative chest tube output. A 30 day follow-up will be conducted to evaluate the patient's tolerance of the product, possible complications, or infection. Additionally, surgeons will be asked to comment on the ease of use of the product.

Eligibility criteria: Inclusion Criteria:

1. Consent given by patient prior to surgery
2. Adult patients over 45 years
3. Subjects requiring elective, prescheduled or urgent open heart surgery requiring a sternotomy including, but not limited to CABG, valve repair, valve replacement

Exclusion Criteria:

1. An immune system disorder
2. Known hypersensitivity to components in BoneSeal® or Ostene®
3. Patients undergoing emergency surgery
4. Patients undergoing aortic dissection
5. No consent given

Primary outcomes:
measure: 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.
measure: Number of Participants Experiencing Re-bleed
timeFrame: 0-3 hours
measure: Hemoglobin
timeFrame: Pre-operative (baseline) and Post-operative (3-6 hours after baseline)
measure: Intra-operative Blood Units
timeFrame: 0-3 hours
measure: Surgical Site Drainage
timeFrame: 6, 12, 18 and 24 hours
measure: Number of Participants With Post Operative Complications Related to the Device
timeFrame: 30 days
measure: Number of Participants Requiring Use of Another Product During Surgery
timeFrame: During surgery, up to 3 hours
measure: End of Surgery Bleeding
timeFrame: End of surgery (closure of the chest)
measure: Post-operative Blood Units
timeFrame: 3-24 hours
measure: Number of Participants With Infection
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda Medical Center
state: California
Study officials:
affiliation: Loma Linda University
name: David G Rabkin, MD, FACS
role: PRINCIPAL_INVESTIGATOR
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