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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02286102
Other study ID # 2014-363
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2011
Est. completion date October 17, 2016

Study information

Verified date October 2019
Source Hospital for Special Surgery, New York
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date October 17, 2016
Est. primary completion date August 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States The Hospital for Special Surgery New York New York

Sponsors (1)

Lead Sponsor Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Hemoglobin Levels, Post-Op Day 3 Hemoglobin levels will be measured post-operatively day 3 3 days postop
Secondary Hemoglobin Levels, Post-Op Day 2 Hemoglobin levels will be measured post-operatively day 2 2 days postop
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