Salient Aquamantys Spine Trial - Full Text View

Purpose

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.

Condition	Intervention	Phase
Blood Loss	Device: Bipolar Sealer (Aquamantys) Procedure: Standard of Care	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research
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

Further study details as provided by Salient Surgical Technologies:

Primary Outcome Measures:

Actual Peri-operative Blood Loss [ Time Frame: Up to 72 hours post-operatively ] [ Designated as safety issue: No ]
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

Secondary Outcome Measures:

Frequency and volume of transfusions [ Time Frame: Up to 72 hours post-operatively ] [ Designated as safety issue: No ]
The frequency and volume of transfusions will be measured between treatment groups
Reduction in hemoglobin and hematocrit values post-operatively [ Time Frame: Upto 72 hours post-operatively ] [ Designated as safety issue: No ]
The reduction in hemoglobin and hematocrit values will be evaluated between the two treatment groups
Length of stay costs and operativ time [ Time Frame: Up to 21 days post-operatively ] [ Designated as safety issue: No ]
Total length of staycosts and operative time will be compared between treatment groups.

Enrollment:	12
Study Start Date:	April 2011
Estimated Study Completion Date:	April 2013
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: 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

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

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Undergoing spinal fusion for < 3 lumbar levels, or using an approach other than direct posterior
Undergoing an interbody fusion
Planned use of hypotensive anaesthesia
Pregnant or lactating
Morbid obesity, defined as Body Mass Index (BMI) greater than 40
Previously diagnosed coagulopathy or bleeding diasthesis
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
History of significant cardiac disorders that would necessitate special fluid management protocols
Serious trauma other than that confined to the spine
History of acute myocardial infarction and/or acute angina within the past year prior to enrollment
PT/INR >1.3 in the 14 days prior to surgery
PTT > 40 in the 14 days prior to surgery
Platelet count <100K in the 14 days prior to surgery
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
Prisoner or transient
Enrolled in another drug or device investigational study (currently or within past 30 days)
Unable or unwilling to sign the Informed Consent Form or comply with protocol specified procedures

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01331499

Locations

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

Sponsors and Collaborators

Salient Surgical Technologies

Investigators

Principal Investigator:

Jeffrey Fischgrund, M.D.

William Beaumont Hospitals

More Information

No publications provided

Responsible Party:	Salient Surgical Technologies
ClinicalTrials.gov Identifier:	NCT01331499 History of Changes
Other Study ID Numbers:	SAL-SP-10-001
Study First Received:	April 6, 2011
Last Updated:	June 6, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Salient Surgical Technologies:

Blood loss
transfusions
instrumented spinal fusion

Additional relevant MeSH terms:

Hemorrhage
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013