Use of ROTEM for Multi-level Spine Surgery
Completed
- Conditions
- Coagulation
- Registration Number
- NCT00839995
- Lead Sponsor
- Weill Medical College of Cornell University
- 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 ROTEM® and routine coagulation tests with each other and with blood loss and transfusion therapies used.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 41
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Coagulation profiles. One measurement before surgery, one after surgery is completed, and one measurement at each i-stat or 10% total blood volume loss.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Weill Cornell Medical College
🇺🇸New York, New York, United States