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Salient Aquamantys Spine Trial

Primary Purpose

Blood Loss

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Bipolar Sealer (Aquamantys)

Standard of Care

About this trial

This is an interventional health services research trial for Blood Loss focused on measuring Blood loss, transfusions, instrumented spinal fusion

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

George Washington University Medical Center
Rush University Medical Center
William Beaumont Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bipolar Sealer

Control

Arm Description

Standard of care blood sparing techniques with bipolar sealer

Standard of care blood sparing techniques without the use of bipolar sealer

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Frequency and volume of transfusions

The frequency and volume of transfusions will be measured between treatment groups

Reduction in hemoglobin and hematocrit values post-operatively

The reduction in hemoglobin and hematocrit values will be evaluated between the two treatment groups

Length of stay costs and operativ time

Total length of staycosts and operative time will be compared between treatment groups.

Full Information

NCT ID

NCT01331499

First Posted

April 6, 2011

Last Updated

June 6, 2012

Sponsor

Salient Surgical Technologies

1. Study Identification

Unique Protocol Identification Number

NCT01331499

Brief Title

Salient Aquamantys Spine 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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2012

Overall Recruitment Status

Terminated

Why Stopped

Study terminated due to Medtronic acquisition

Study Start Date

April 2011 (undefined)

Primary Completion Date

December 2012 (Anticipated)

Study Completion Date

April 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Salient Surgical Technologies

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Blood Loss

Keywords

Blood loss, transfusions, instrumented spinal fusion

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bipolar Sealer

Arm Type

Experimental

Arm Description

Standard of care blood sparing techniques with bipolar sealer

Arm Title

Control

Arm Type

Active Comparator

Arm Description

Standard of care blood sparing techniques without the use of bipolar sealer

Intervention Type

Device

Intervention Name(s)

Bipolar Sealer (Aquamantys)

Other Intervention Name(s)

Aquamantys

Intervention Description

Standard of care blood sparing techniques along with the use of bipolar sealer

Intervention Type

Procedure

Intervention Name(s)

Standard of Care

Intervention Description

Standard of care blood sparing techniques without the useof bipolar sealer

Primary Outcome Measure Information:

Title

Actual Peri-operative Blood Loss

Description

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

Time Frame

Up to 72 hours post-operatively

Secondary Outcome Measure Information:

Title

Frequency and volume of transfusions

Description

The frequency and volume of transfusions will be measured between treatment groups

Time Frame

Up to 72 hours post-operatively

Title

Reduction in hemoglobin and hematocrit values post-operatively

Description

The reduction in hemoglobin and hematocrit values will be evaluated between the two treatment groups

Time Frame

Upto 72 hours post-operatively

Title

Length of stay costs and operativ time

Description

Total length of staycosts and operative time will be compared between treatment groups.

Time Frame

Up to 21 days post-operatively

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jeffrey Fischgrund, M.D.

Organizational Affiliation

William Beaumont Hospitals

Official's Role

Principal Investigator

Facility Information:

Facility Name

George Washington University Medical Center

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20037

Country

United States

Facility Name

Rush University Medical Center

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

Facility Name

William Beaumont Hospital

City

Royal Oak

State/Province

Michigan

ZIP/Postal Code

48073

Country

United States

12. IPD Sharing Statement

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Salient Aquamantys Spine Trial

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