Salient Aquamantys Spine Trial

Phase 4

Terminated

• Conditions: Blood Loss

• 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

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-04-06
• Study First Submitted QC: 2011-04-07
• Study First Posted: 2011-04-08
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-06
• Last Update Posted: 2012-06-07
• Primary Completion: 2012-12
• Study Completion: 2013-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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)

George Washington University Medical Center; 🇺🇸 Washington, District of Columbia, United States

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

William Beaumont Hospital; 🇺🇸 Royal Oak, Michigan, United States