A Prospective Randomized Study on the Clinical Benefits of OrthoPAT Drains

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2016-10-17

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Spine Deformity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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OrthoPAT

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.

Group Type EXPERIMENTAL

OrthoPAT

Intervention Type DEVICE

OrthoPAT drain to collect and retransfuse postoperative blood loss. Drains will be removed 48 hours postoperatively

Constavac

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

Group Type ACTIVE_COMPARATOR

Constavac

Intervention Type DEVICE

Constavac drain to collect postoperative blood loss. Drains will be removed 48 hours postoperatively

Interventions

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OrthoPAT

OrthoPAT drain to collect and retransfuse postoperative blood loss. Drains will be removed 48 hours postoperatively

Intervention Type DEVICE

Constavac

Constavac drain to collect postoperative blood loss. Drains will be removed 48 hours postoperatively

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes