Salient Aquamantys Spine Trial
- Conditions
- Blood Loss
- Interventions
- Device: Bipolar Sealer (Aquamantys)Procedure: Standard of Care
- Registration Number
- NCT01331499
- Lead Sponsor
- Salient Surgical Technologies
- 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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 12
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bipolar Sealer Bipolar Sealer (Aquamantys) Standard of care blood sparing techniques with bipolar sealer Control Standard of Care Standard of care blood sparing techniques without the use of bipolar sealer
- Primary Outcome Measures
Name Time Method Actual Peri-operative Blood Loss Up to 72 hours post-operatively 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
Name Time Method Frequency and volume of transfusions Up to 72 hours post-operatively The frequency and volume of transfusions will be measured between treatment groups
Reduction in hemoglobin and hematocrit values post-operatively Upto 72 hours post-operatively The reduction in hemoglobin and hematocrit values will be evaluated between the two treatment groups
Length of stay costs and operativ time Up to 21 days post-operatively Total length of staycosts and operative time will be compared between treatment groups.
Trial Locations
- Locations (3)
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
George Washington University Medical Center
🇺🇸Washington, District of Columbia, United States