A Prospective Randomized Study on the Clinical Benefits of OrthoPAT Drains



Status:Completed
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:18 - Any
Updated:4/2/2016
Start Date:January 2011
End Date:December 2015
Contact:Tom Ross, RN
Email:rosst@hss.edu
Phone:212-606-1723

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A Prospective Randomized Study on the Clinical Benefits of OrthoPAT Drains for Adults Undergoing Multilevel Spine Surgery for Deformity

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 more.

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 adult patients undergoing multilevel spine surgery for deformity. In
addition, the ability of these drains to decrease the complications that are associated with
allogenic blood exposure (postoperative infection, volume overload and transfusion
reactions) will also be evaluated.

Inclusion Criteria:

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 Criteria:

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.
We found this trial at
1
site
535 E 70th St
New York, New York 10021
(212) 606-1000
Hospital for Special Surgery Founded in 1863, Hospital for Special Surgery is the nation
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mi
from
New York, NY
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