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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
History of Changes

February 6, 2009
March 2, 2012
February 2009
December 2010   (final data collection date for primary outcome measure)
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 ]
Coagulation profiles. [ Time Frame: One measurement before surgery, one after surgery is completed, and at one measurement at each i-stat. ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00839995 on ClinicalTrials.gov Archive Site
Not Provided
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Use of ROTEM for Multi-level Spine Surgery
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.
Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

a small sample of blood will be obtained from a pre-existing arterial line.
Non-Probability Sample

Large metropolitan hospital.
Coagulation
Not Provided
Patients undergoing multi-level spine surgery

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
41
December 2011
December 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00839995
0811010079
No
Hugh Hemmings, Weill Medical College of Cornell University
Weill Medical College of Cornell University
Not Provided
Principal Investigator: Hugh C Hemmings, M.D., Ph.D. Weill Medical College of Cornell University
Weill Medical College of Cornell University
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP