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Effectiveness of BoneSeal® on Bone Hemostats in Patients Undergoing Cardiothoracic Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03085017
Recruitment Status : Unknown
Verified June 2017 by Nahidh Hasaniya, Loma Linda University.
Recruitment status was:  Recruiting
First Posted : March 21, 2017
Last Update Posted : June 9, 2017
Sponsor:
Information provided by (Responsible Party):
Nahidh Hasaniya, Loma Linda University

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Bypass Grafting Device: BoneSeal Device: Ostene Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Effectiveness of BoneSeal® on Bone Hemostats in Patients Undergoing Cardiothoracic Surgery
Actual Study Start Date : June 7, 2017
Estimated Primary Completion Date : June 7, 2018
Estimated Study Completion Date : August 7, 2018

Arm Intervention/treatment
Active Comparator: Ostene Device: Ostene
OSTENE is a synthetic, biodissolvable implant material that, provides immediate bone hemostasis, can be used on all bleeding bone surfaces, is completely biocompatible and water-soluble polymer, is a mechanical barrier that does not act biochemically.

Experimental: BoneSeal Device: BoneSeal
BoneSeal® is an absorbable synthetic bone hemostats that also contains of PLA, PEG and hydroxyapatite which supports bone re-growth. Product code MTJ. FDA number K142348.




Primary Outcome Measures :
  1. Hemostatic Action [ Time Frame: 3-6 hours ]
    Qualitative determination of bleeding and hemostatic action during application graded by the surgeon using the mild, moderate, and severe for bleeding and complete, moderate, minimal, and failure for hemostatic action.

  2. Occurrence of Re-bleed [ Time Frame: 3-6 hours ]
    Occurrence of re-bleeding during the operation will be noted. Reapplication of product will not occur.

  3. Postoperative hemoglobin [ Time Frame: 3-6 hours ]
    Postoperative hemoglobin as compared to baseline preoperative readings

  4. Blood product transfusion quantities [ Time Frame: 3-6 hours ]
    Intra-operative and post-operative blood product transfusion quantities in total

  5. Surgical Site Drainage [ Time Frame: 24 hours ]
    Post-operative chest tube output

  6. Post Operative Complications [ Time Frame: 30 days ]
    Sternal wound infection or other complications within 30 days post procedure



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03085017


Contacts
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Contact: Nahidh W Hasaniya, MD, PhD 909-558-4355 nhasaniya@llu.edu
Contact: Vanessa L Ayer Miller, MS 9095584355 vayermiller@llu.edu

Locations
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United States, California
Loma Linda Medical Center Recruiting
Loma Linda, California, United States, 92354
Contact: Nahidh Hasaniya, MD,PhD    909-558-4354    nhasaniya@llu.edu   
Contact: Vanessa L Ayer Miller, MS    9095584355    vayermiller@llu.edu   
Sponsors and Collaborators
Loma Linda University
Investigators
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Principal Investigator: Nahidh W Hasaniya, MD, PhD Loma Linda University
Publications:
Light R. Hemostasis in neurosurgery. Journal of neurosurgery. 1945; 2(5): p. 414-34.

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Responsible Party: Nahidh Hasaniya, Associate Professor, Loma Linda University
ClinicalTrials.gov Identifier: NCT03085017    
Other Study ID Numbers: 5160386
16042 ( Other Identifier: Loma Linda Clinial Trials Center )
First Posted: March 21, 2017    Key Record Dates
Last Update Posted: June 9, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes