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 @ 11:48 PM
Ignite Modification Date:
2025-12-24 @ 11:48 PM
NCT ID:
NCT05340751
Eligibility Criteria:
Inclusion Criteria:
* Non- inflammatory degenerative joint disease of the knee
* Patients scheduled for unilateral primary total Knee arthroplasty
* Age between 40 and 80 years
* Hypotensive spinal-epidural anesthesia with systolic BP \< 95 and diastolic BP \< 65.
* Adequate intraoperative fluid loading: a minimum of 1500 ml IV fluids should be infused during procedure: at least 300 cc/15 minutes.
Exclusion Criteria:
* Blood coagulopathies resulting in a hypocoagulable state (hemophilia, von Willebrand disease, etc.)
* Blood coagulopathies resulting in a hypercoagulable state (factor V leiden, antithrombin III deficiency, protein C deficiency, protein S deficiency)
* Patients on anti-coagulants (coumadin, plavix, pradaxa, heparin)
* Congestive Heart Failure (at least one medication to treat congestive heart failure)
* Coronary artery disease (s/p bypass, stent or AMI)
* Kidney insufficiency (creatinine \> 1.5)
* Aortic or mitral valve disease
* Pulmonary hypertension
* Revision Knee Surgery
* Inadequate intravenous fluid substitution during the procedure 1.5L during 60 minutes.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT05340751
Study Brief:
Protocol Section:
NCT05340751