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 @ 2:49 PM
Ignite Modification Date:
2025-12-24 @ 2:49 PM
NCT ID:
NCT01300559
Eligibility Criteria:
Inclusion Criteria:
* Age: 18 years and older
* Sex: Both males and females will be included
* Patient has a Body Mass Index (BMI) \<40
* Patient is willing and able to cooperate
* Patient is in stable health and cleared for surgery
* Patient is a candidate for elective multilevel posterior lumbar compression and fusion spinal surgery at least two or greater lumbar level involvement
* Patient has completed the Informed Consent Form
Exclusion Criteria:
* Patient is unable or unwilling to comply with the entire study protocol
* Patient has a previously diagnosed coagulopathy
* Patient has preoperative hemoglobin \<11 g/dL
* Patient has a Prothrombin Time and International Normalized Ratio (PT/INR) \>1.3
* Patient has a Partial Thromboplastin Time (PTT) \>40
* Patient has a platelet count \<100k
* Patients will also be excluded if taking non-aspirin medications producing a bleeding diathesis undetectable by screening labs such as clopidogrel or ticlopidine within seven days of surgery or valproic acid (associated with thrombocytopenia)
* Trauma patients are excluded
* Patient is a poor compliance risk, i.e., history of ethanol, drug abuse
* Severe cardiac disorder requiring special fluid management protocols
* Patients with acute myocardial infarction and/or acute angina
* Patient is on Plavix or other long term anti-coagulation including aspirin (ASA) or other nonsteroidal antiinflammatory drugs (NSAIDs) may be included provided their medications are discontinued a minimum of 7 days prior to surgery
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01300559
Study Brief:
Protocol Section:
NCT01300559