Use of ROTEM for Multi-level Spine Surgery (ROTEM)

March 2, 2012 updated by: Hugh Hemmings, Weill Medical College of Cornell University

A Prospective Observational Study to Evaluate Perioperative Coagulation Profiles Using Rotational Thromboelastometry (ROTEM®) in Patients Undergoing Multi-level Spine Surgery

The purpose of this study is to obtain coagulation profiles of patients undergoing multi-level spine surgeries with ROTEM® and routine coagulation tests. The investigators will compare the data from ROTEM® and routine coagulation tests with each other and with blood loss and transfusion therapies used.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

41

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Weill Cornell Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Large metropolitan hospital.

Description

Inclusion Criteria:

  • Patients undergoing elective open spine (cervical, thoracic, and/or lumbar) surgery with anticipated blood loss of > 1 L
  • Males and females
  • Age 18 to 100 years of age
  • ASA physical status 1 to 3
  • Arterial line indicated for the intraoperative management of the patient and in place prior to incision
  • Informed consent obtained

Exclusion Criteria:

  • Known pre-existing hemostatic abnormality
  • Known clopidogrel use within 10 days prior to surgery
  • Known warfarin use within 5 days prior to surgery
  • Known pregnancy
  • Has physical, mental, or medical conditions which, in the opinion of the Investigator, could compromise the subject's welfare, ability to communicate with the study staff, complete study activities, or would otherwise contraindicate study participation.
  • Inclusion in another clinical research study
  • An investigator of this study
  • Subject's refusal or inability to agree to and sign the Informed Consent form in English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients undergoing multi-level spine surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Coagulation profiles.
Time Frame: One measurement before surgery, one after surgery is completed, and one measurement at each i-stat or 10% total blood volume loss.
One measurement before surgery, one after surgery is completed, and one measurement at each i-stat or 10% total blood volume loss.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Investigators

  • Principal Investigator: Hugh C Hemmings, M.D., Ph.D., Weill Medical College of Cornell University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

February 6, 2009

First Submitted That Met QC Criteria

February 9, 2009

First Posted (Estimate)

February 10, 2009

Study Record Updates

Last Update Posted (Estimate)

March 5, 2012

Last Update Submitted That Met QC Criteria

March 2, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 0811010079

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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