Salient Aquamantys Spine Trial

Blood Loss Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01331499
• Other study ID #: SAL-SP-10-001
• Status: Terminated
• Phase: Phase 4
• First received: April 6, 2011
• Last updated: June 6, 2012
• Start date: April 2011
• Est. completion date: April 2013

Study information

• Verified date: June 2012
• Source: Salient Surgical Technologies
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: April 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Loss
• Hemorrhage

Intervention

Device:
• Bipolar Sealer (Aquamantys)
Standard of care blood sparing techniques along with the use of bipolar sealer

Procedure:
• Standard of Care
Standard of care blood sparing techniques without the useof bipolar sealer

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Salient Surgical Technologies

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Frequency and volume of transfusions	The frequency and volume of transfusions will be measured between treatment groups	Up to 72 hours post-operatively
Secondary	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
Secondary	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