Status:
COMPLETED
A Prospective Randomized Study on the Clinical Benefits of OrthoPAT Drains
Lead Sponsor:
Hospital for Special Surgery, New York
Conditions:
Spine Deformity
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The examination of the ability of the OrthoPAT® blood collection device to decrease the transfusion rate and volume of adults undergoing posterior spine surgery for deformity correction of 6 levels or...
Detailed Description
The purpose of this study is to investigate the use of postoperative drains with blood salvage capabilities to determine if they decrease both the volume and rate of allogenic blood transfusion in adu...
Eligibility Criteria
Inclusion
- The patient is at least 18 years of age The patient is to undergo posterior spine surgery in the thoracic or lumbar region for deformity correction of greater than 6 levels The patient has signed a patient Informed Consent
Exclusion
- The patient is less than 18 years of age The patient has a hematologic disorder of any etiology The patient has received active anticoagulant therapy, including aspirin, Plavix, Heparin, Lovenox or Coumadin within one week of admission The patient has a known active infection or malignancy. The patient has a terminal illness with a life expectancy of less than one year.
- The patient requires immuno-suppressive therapy. The patient is undergoing a combined anterior/posterior fusion. The patient has a history of drug or alcohol abuse that may interfere with his/her ability to provide written informed consent.
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 17 2016
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT02286102
Start Date
January 1 2011
End Date
October 17 2016
Last Update
October 29 2019
Active Locations (1)
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1
The Hospital for Special Surgery
New York, New York, United States, 10021