Use of ROTEM for Multi-level Spine Surgery (ROTEM)
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ClinicalTrials.gov Identifier: NCT00839995
Recruitment Status :
First Posted : February 10, 2009
Last Update Posted : March 5, 2012
Weill Medical College of Cornell University
Information provided by (Responsible Party):
Hugh Hemmings, Weill Medical College of Cornell University
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.
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Ages Eligible for Study:
18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Large metropolitan hospital.
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
Known pre-existing hemostatic abnormality
Known clopidogrel use within 10 days prior to surgery
Known warfarin use within 5 days prior to surgery
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