A Prospective Randomized Study on the Clinical Benefits of OrthoPAT Drains

Completed · Not applicable

Conditions studied: Spine Deformity

In brief

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.

Key facts

Study ID

NCT02286102

Run by

Hospital for Special Surgery, New York

People needed

70

Starts

2011-01-01

Expected to finish

2016-10-17

Last updated by the study team

2019-10-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• The Hospital for Special Surgery — New York, New York, United States

Full record on ClinicalTrials.gov

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