Salient Aquamantys Spine Trial

NCT01331499 | Terminated Phase 4

• 1 other identifier: SAL-SP-10-001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 3

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.

Conditions

Blood Loss

Keywords

Blood loss; transfusions; instrumented spinal fusion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Frequency and volume of transfusions

  Up to 72 hours post-operatively

• Reduction in hemoglobin and hematocrit values post-operatively

  Upto 72 hours post-operatively

• Length of stay costs and operativ time

  Up to 21 days post-operatively

Study Arms (2)

Bipolar Sealer

EXPERIMENTAL

Standard of care blood sparing techniques with bipolar sealer

Device: Bipolar Sealer (Aquamantys)

Control

ACTIVE COMPARATOR

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

Procedure: Standard of Care

Interventions

Bipolar Sealer (Aquamantys) DEVICE

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

Also known as: Aquamantys

Bipolar Sealer

Standard of Care PROCEDURE

Standard of care blood sparing techniques without the useof bipolar sealer

Control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Salient Surgical Technologies: lead

Study Sites (3)

George Washington University Medical Center

Washington D.C., District of Columbia, 20037, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Conditions

Hemorrhage

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Jeffrey Fischgrund, M.D.

  Corewell Health East

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2011
• First Posted: April 8, 2011
• Study Start: April 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: April 1, 2013
• Last Updated: June 7, 2012

Record last verified: 2012-06

Locations

US (3)