A Prospective Randomized Study on the Clinical Benefits of OrthoPAT Drains

Study Overview
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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.

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.

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

Conditions
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Spine Deformity

Intervention / Treatment
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* Device: OrthoPAT
* Device: Constavac


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OrthoPAT<br>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. | Device: OrthoPAT<br>* OrthoPAT drain to collect and retransfuse postoperative blood loss. Drains will be removed 48 hours postoperatively<br>|
| Active Comparator: Constavac<br>Patients identified as active comparator will receive standard Constavac drains, which will be removed after 48 hours. | Device: Constavac<br>* Constavac drain to collect postoperative blood loss. Drains will be removed 48 hours postoperatively<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume of Allogenic Blood Transfused Postoperatively | The total volume of allogenic blood transfused postoperatively will be measured during the first 48 hours postoperatively while the drains are in place. | 48 hours postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin Levels, Post-Op Day 3 | Hemoglobin levels will be measured post-operatively day 3 | 3 days postop | 
| Hemoglobin Levels, Post-Op Day 2 | Hemoglobin levels will be measured post-operatively day 2 | 2 days postop |