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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00839995
First Posted: February 10, 2009
Last Update Posted: March 5, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hugh Hemmings, Weill Medical College of Cornell University
  Purpose
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.

Condition
Coagulation

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Prospective Observational Study to Evaluate Perioperative Coagulation Profiles Using Rotational Thromboelastometry (ROTEM®) in Patients Undergoing Multi-level Spine Surgery

Further study details as provided by Hugh Hemmings, Weill Medical College of Cornell University:

Primary Outcome Measures:
  • 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. ]

Biospecimen Retention:   Samples With DNA
a small sample of blood will be obtained from a pre-existing arterial line.

Enrollment: 41
Study Start Date: February 2009
Study Completion Date: December 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients undergoing multi-level spine surgery

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Large metropolitan hospital.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00839995


Locations
United States, New York
Weill Cornell Medical College
New York, New York, United States, 10065
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Hugh C Hemmings, M.D., Ph.D. Weill Medical College of Cornell University
  More Information

Publications:

Responsible Party: Hugh Hemmings, Vice Chair of Research, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00839995     History of Changes
Other Study ID Numbers: 0811010079
First Submitted: February 6, 2009
First Posted: February 10, 2009
Last Update Posted: March 5, 2012
Last Verified: February 2012

Keywords provided by Hugh Hemmings, Weill Medical College of Cornell University:
To determine the efficacy of ROTEM on assessing coagulation profiles.