Surgical Bleeding
Conditions
Keywords
Elective, spine surgery, bleeding control, hemostasis
Brief summary
The purpose of this clinical investigation in open, elective, spine surgery is to collect data to support the removal of the neurosurgical exclusion from the currently approved indication for the use of HEMOBLAST™ Bellows. This study is primarily designed to assess safety of the device for use in spine surgery, although efficacy information will also be captured and reported.
Interventions
DEVICEHEMOBLAST™ Bellows
Intraoperative bleeding during epidural spine surgery will be treated with HEMOBLAST™ Bellows
DEVICEabsorbable gelatin sponge with thrombin
Intraoperative bleeding during epidural spine surgery will be treated with absorbable gelatin sponge with thrombin
Sponsors
Syneos Health
Dilon Technologies Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
data blinding to Sponsor, Independent Data Monitoring Committee, FDA reviewer
Intervention model description
Prospective, Randomized, Controlled, Multicenter, Clinical Investigation
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is undergoing open, elective, spine surgery * Subject or an authorized legal representative is willing and able to give prior written informed consent for investigation participation * Subject is 22 years of age or older * Subject does not have an active or suspected infection at the surgical site * Subject in whom the Investigator is able to identify a Target Bleeding Site (TBS) for which any applicable conventional means for hemostasis are ineffective or impractical * Subject has a TBS with a Surface Bleeding Severity Scale (SBSS) score of 1, 2, or 3
Exclusion criteria
* Subject is undergoing an emergency surgical procedure * Subject is undergoing a laparoscopic surgery * Subject is undergoing a cervical spine surgery * Subject is pregnant, planning on becoming pregnant during the follow-up period, or actively breast-feeding * Subject has a platelet count \< 100,000 per microliter or International Normalized Ratio \> 1.5 within 4 weeks of surgery * Subject receiving intravenous heparin within 12 hours before surgery or oral Coumadin within 2 days before surgery * Subject receiving antiplatelet medications within 5 days prior to surgery * Subject receiving aspirin within 7 days prior to surgery * Subject has an active or suspected infection at the surgical site * Subject has had or has planned to receive any organ transplantation * Subject has a known sensitivity or allergy to bovine and/or porcine substance(s) or any other component(s) of the hemostatic agent * Subject has a known sensitivity or allergy to Gadolinium * The subject has a contra-indication for MRI or gadolinium contrast agent according to clinical guidelines, local regulations or manufacturer's recommendations * Subject suffers from claustrophobia or fear of MRI, or has any contraindication to MRI (e.g., metal implants, spinal cord stimulator, etc. not suited to MRI) * Subject has American Society of Anesthesiologists classification of \> 4 * Subject has a life expectancy of less than 3 months * Subject has a documented severe congenital or acquired immunodeficiency * Subject has religious or other objections to porcine, bovine, or human components * Subject is currently participating or has participated in another clinical trial within the past 30 days and is receiving/has received an investigational drug, device, or biologic agent * Per investigator opinion subject is unable to fully cooperate with the study protocol. * The product will be placed in at the site where the dura is open * The product will be placed in the intradural or cranial space
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Unanticipated Adverse Device Effect (UADE) | 3 months follow-up | incidence of UADE, for subjects treated with HEMOBLAST™, as determined by the Independent Data Monitoring Committee (IDMC). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events (AE) | 3 months follow-up | the proportion of AEs for subjects treated with HEMOBLAST™ compared to subjects treated with G+T. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Hemostasis within 6 minutes | immediately after procedure | Proportion of subjects achieving hemostasis within 6 minutes for HEMOBLAST™ subjects compared to G+T subjects |
| Operative time | immediately after procedure | Operative time for HEMOBLAST™ subjects compared to G+T subjects |
| Length of stay | From procedure to discharge, estimated average = 36 hours | Duration of hospitalization for HEMOBLAST™ subjects compared to G+T subjects |
| Blood transfusions | From procedure to discharge, estimated average = 36 hours | Number of units of blood transfused intraoperatively for HEMOBLAST™ subjects compared to G+T subjects |
Countries
United States
Outcome results
None listed