Salient Aquamantys Spine Trial

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

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.

Study Overview

• Status: Terminated
• Conditions: Blood Loss
• Intervention / Treatment: Device: Bipolar Sealer (Aquamantys); Procedure: Standard of Care

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

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • George Washington University Medical Center
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Bipolar Sealer; Standard of care blood sparing techniques with bipolar sealer	Device: Bipolar Sealer (Aquamantys); Standard of care blood sparing techniques along with the use of bipolar sealer; Other Names: Aquamantys
ACTIVE_COMPARATOR: Control; Standard of care blood sparing techniques without the use of bipolar sealer	Procedure: Standard of Care; Standard of care blood sparing techniques without the useof bipolar sealer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Actual Peri-operative Blood Loss	Actual blood loss (ABL) will be calculated using a study specified formula using laboratory data from up to 72 hours post-surgery. ABL will be compared between treatment groups	Up to 72 hours post-operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency and volume of transfusions	The frequency and volume of transfusions will be measured between treatment groups	Up to 72 hours post-operatively
Reduction in hemoglobin and hematocrit values post-operatively	The reduction in hemoglobin and hematocrit values will be evaluated between the two treatment groups	Upto 72 hours post-operatively
Length of stay costs and operativ time	Total length of staycosts and operative time will be compared between treatment groups.	Up to 21 days post-operatively

Collaborators and Investigators

• Sponsor: Salient Surgical Technologies
• Investigators: Principal Investigator: Jeffrey Fischgrund, M.D., William Beaumont Hospitals

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (ANTICIPATED): December 1, 2012
• Study Completion (ANTICIPATED): April 1, 2013

Study Registration Dates

• First Submitted: April 6, 2011
• First Submitted That Met QC Criteria: April 7, 2011
• First Posted (ESTIMATE): April 8, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): June 7, 2012
• Last Update Submitted That Met QC Criteria: June 6, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: transfusions; instrumented spinal fusion; Blood loss
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: SAL-SP-10-001