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Completed

NCT Number: NCT02286102

A Prospective Randomized Study on the Clinical Benefits of OrthoPAT Drains

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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Key information

Conditions

Spine Deformity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hospital for Special Surgery

New York, 10021, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

OrthoPAT

Device

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

Constavac

Device

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

Primary outcomes

  1. Volume of Allogenic Blood Transfused Postoperatively

    Time frame: 48 hours postoperative

    The total volume of allogenic blood transfused postoperatively will be measured during the first 48 hours postoperatively while the drains are in place.

Secondary outcomes

  1. Hemoglobin Levels, Post-Op Day 3

    Time frame: 3 days postop

    Hemoglobin levels will be measured post-operatively day 3

  2. Hemoglobin Levels, Post-Op Day 2

    Time frame: 2 days postop

    Hemoglobin levels will be measured post-operatively day 2

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2015
Study completion
2016
First posted
Nov 7, 2014
Registry last updated
Oct 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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