N/A
N=57
Effectiveness of BoneSeal® on Bone Hemostats in Patients Undergoing Cardiothoracic Surgery
Coronary Artery Bypass Grafting
Bottom Line
View on ClinicalTrials.gov: NCT03085017 ↗Enrolled (actual)
57
Serious AEs
1.8%
Results posted
Sep 2020
Primary outcome: Primary: Ease of Use — 4; 1 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- BoneSeal (Device); Ostene (Device)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- Loma Linda University
- Primary completion
- Oct 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ease of Use |
4; 1 | — |
| PRIMARY Number of Participants Experiencing Re-bleed |
25; 3 | — |
| PRIMARY Hemoglobin |
12.7; 12.7; 9.9; 10.9 | — |
| PRIMARY Intra-operative Blood Units |
0.50; 0.26 | — |
| PRIMARY Surgical Site Drainage |
309.3; 294.3; 463.7; 439.3; 598.4; 568.3 | — |
| PRIMARY Number of Participants With Post Operative Complications Related to the Device |
2; 0 | — |
| PRIMARY Number of Participants Requiring Use of Another Product During Surgery |
13; 1 | — |
| PRIMARY End of Surgery Bleeding |
4; 2 | — |
| PRIMARY Post-operative Blood Units |
0.50; 0.26 | — |
| PRIMARY Number of Participants With Infection |
1; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Consent given by patient prior to surgery
- Adult patients over 45 years
- Subjects requiring elective, prescheduled or urgent open heart surgery requiring a sternotomy including, but not limited to CABG, valve repair, valve replacement
Exclusion Criteria
- An immune system disorder
- Known hypersensitivity to components in BoneSeal® or Ostene®
- Patients undergoing emergency surgery
- Patients undergoing aortic dissection
- No consent given
Data sourced from ClinicalTrials.gov (NCT03085017). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.