A Prospective Randomized Study on the Clinical Benefits of OrthoPAT Drains

Hospital for Special Surgery (HSS)

Status: Completed

Conditions: Spine Deformity

Treatments: Device: Constavac; Device: OrthoPAT

Study type: Interventional

Funder types: Other

Identifiers

NCT02286102

2014-363

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

OrthoPAT

Experimental group

Description:

Patients in the experimental group will receive OrthoPAT drains, which will be used to collect and retransfuse postoperative blood loss. Drains will be removed after 48 hours.

Treatment:

Device: OrthoPAT

Constavac

Active Comparator group

Description:

Patients identified as active comparator will receive standard Constavac drains, which will be removed after 48 hours.

Treatment:

Device: Constavac