Use of ROTEM for Multi-level Spine Surgery

Weill Cornell Medicine (WCM)

Status: Completed

Conditions: Coagulation

Study type: Observational

Funder types: Other

Identifiers

NCT00839995

0811010079

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

41 participants in 1 patient group

Patients undergoing multi-level spine surgery