Clinical trial NCT01331499: Salient Aquamantys Spine Trial
Official title: A Post-Market, Prospective, Multicenter, Randomized Trial Comparing the Use of Standard of Care Blood Sparing Techniques With and Without the Aquamantys System to Facilitate Hemostasis in Subjects Undergoing Multi-level Spinal Fusions
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Blood Loss
Keywords: Blood loss
transfusions
instrumented spinal fusion
Lead sponsor: Salient Surgical Technologies
Sponsor class: INDUSTRY
First posted: 2011-04-08
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to compare standard of care hemostasis techniques with and without the use of Aquamantys in reducing peri-operative blood loss.

Detailed description: The primary objective of the study is to assess the effectiveness of Aquamantys in reducing peri-operative blood loss compared with standard electrocautery

Secondary objectives include :

* Rate and volume of transfusions
* Evaluating the reduction in hemoglobin and hematocrit values post- operatively
* LOS costs, and operative time
* Gathering operator feedback on qualitative criteria, including ease of use and surgical visualization between the two treatment groups

Eligibility criteria: Inclusion Criteria:

1. Be candidate for three level (or greater) fusion surgery from T1 to S1 utilizing a direct posterior approach
2. Male or female 18 to 70 years of age (inclusive)
3. Must sign the IRB approved Informed Consent Form

Exclusion Criteria:

1. Undergoing spinal fusion for \< 3 lumbar levels, or using an approach other than direct posterior
2. Undergoing an interbody fusion
3. Planned use of hypotensive anaesthesia
4. Pregnant or lactating
5. Morbid obesity, defined as Body Mass Index (BMI) greater than 40
6. Previously diagnosed coagulopathy or bleeding diasthesis
7. Currently, or within the previous 7 days prior to surgery, taking any medications that would produce bleeding diathesis including, but not limited to NSAIDs, aspirin, clopidogrel (Plavix), ticlopidine, or valproic acid
8. History of significant cardiac disorders that would necessitate special fluid management protocols
9. Serious trauma other than that confined to the spine
10. History of acute myocardial infarction and/or acute angina within the past year prior to enrollment
11. PT/INR \>1.3 in the 14 days prior to surgery
12. PTT \> 40 in the 14 days prior to surgery
13. Platelet count \<100K in the 14 days prior to surgery
14. Based on clinical history, physical exam and subject presentation, subject has or is suspected to have a history of alcohol and/or drug abuse that would preclude subject from providing adequate consent and/or complying with study requirements
15. Prisoner or transient
16. Enrolled in another drug or device investigational study (currently or within past 30 days)
17. Unable or unwilling to sign the Informed Consent Form or comply with protocol specified procedures

Primary outcomes:
measure: Actual Peri-operative Blood Loss
timeFrame: Up to 72 hours post-operatively
Secondary outcomes:
measure: Frequency and volume of transfusions
timeFrame: Up to 72 hours post-operatively
measure: Reduction in hemoglobin and hematocrit values post-operatively
timeFrame: Upto 72 hours post-operatively
measure: Length of stay costs and operativ time
timeFrame: Up to 21 days post-operatively
Other outcomes:
Locations:
city: Washington
country: United States
facility: George Washington University Medical Center
state: District of Columbia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
Study officials:
affiliation: William Beaumont Hospitals
name: Jeffrey Fischgrund, M.D.
role: PRINCIPAL_INVESTIGATOR
References: