Salient Aquamantys Spine Trial

Stopped early · Phase 4

Conditions studied: Blood Loss

In brief

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.

Key facts

Study ID

NCT01331499

Run by

Salient Surgical Technologies

People needed

12

Starts

2011-04-01

Expected to finish

2013-04-01

Last updated by the study team

2012-06-07

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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
• 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

Where it is running

• George Washington University Medical Center — Washington D.C., District of Columbia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• William Beaumont Hospital — Royal Oak, Michigan, United States

Full record on ClinicalTrials.gov

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