Salient Aquamantys Spine Trial

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Blood Loss

Intervention / Treatment
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* Device: Bipolar Sealer (Aquamantys)
* Procedure: Standard of Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bipolar Sealer<br>Standard of care blood sparing techniques with bipolar sealer | Device: Bipolar Sealer (Aquamantys)<br>* Standard of care blood sparing techniques along with the use of bipolar sealer<br>* Other names: Aquamantys;|
| Active Comparator: Control<br>Standard of care blood sparing techniques without the use of bipolar sealer | Procedure: Standard of Care<br>* Standard of care blood sparing techniques without the useof bipolar sealer<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood loss, transfusions, instrumented spinal fusion