Blood Loss
Conditions
Keywords
Blood loss, transfusions, instrumented spinal fusion
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
Interventions
DEVICEBipolar Sealer (Aquamantys)
Standard of care blood sparing techniques along with the use of bipolar sealer
PROCEDUREStandard of Care
Standard of care blood sparing techniques without the useof bipolar sealer
Sponsors
Salient Surgical Technologies
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed