Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:05 PM
Ignite Modification Date:
2025-12-24 @ 2:05 PM
NCT ID:
NCT00839995
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00839995
Study Brief:
Protocol Section:
NCT00839995