A Prospective Randomized Study on the Clinical Benefits of OrthoPAT Drains

Spine Deformity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02286102
• Other study ID #: 2014-363
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Congenital Abnormalities
• Spine Deformity

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