Status:

COMPLETED

Use of ROTEM for Multi-level Spine Surgery

Lead Sponsor:

Weill Medical College of Cornell University

Conditions:

Coagulation

Eligibility:

All Genders

18-80 years

Brief Summary

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 R...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

February 1 2009

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

December 1 2011

Estimated Enrollment :

41 Patients enrolled

Trial Details

Trial ID

NCT00839995

Start Date

February 1 2009

End Date

December 1 2011

Last Update

March 5 2012

Active Locations (1)

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1

Weill Cornell Medical College

New York, New York, United States, 10065