Use of ROTEM for Multi-level Spine Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hugh Hemmings, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00839995
First received: February 6, 2009
Last updated: March 2, 2012
Last verified: February 2012
  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 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. ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
Mannucci PM, Levi M. Prevention and treatment of major blood loss. N Engl J Med 2007; 356(22):2301-2311
Hänecke P, Klouchea M. Thrombelastography today: practicability and analytical power. Transfus Med Hemother 2007; 34:421-428
Luddington RJ. Thrombelastography/thromboelastometry. Clin Lab Haematol 2005; 27(2):81-90

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
Study First Received: February 6, 2009
Last Updated: March 2, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 18, 2014