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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05340751
Other study ID # 2015-081
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2014
Est. completion date September 1, 2014

Study information

Verified date April 2022
Source Hospital for Special Surgery, New York
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The current study investigates the effect of hypotensive anesthesia on patient hemoglobin levels during primary total knee arthroplasty. Considering that because of the tourniquet there is no blood loss during the first 60 minutes of the procedure changes in hemoglobin during the first 60 minutes should be primarily related to decrease in blood pressure and secondary to fluid loading during hypotensive anesthesia.


Description:

The specific aim of this prospective study is to collect serial hemoglobin levels intraoperatively during hypotensive anesthesia to evaluate if intraoperative intravenous fluid substitution will change hemoglobin levels during the time the tourniquet is inflated (no blood loss). The combination of vasodilation during hypotensive anesthesia and fluid substitution will result in decrease of hemoglobin levels during the tourniquet time. Tubes of 5cc to measure hemoglobin and hematocrit levels preoperatively, prior to inflation of the tourniquet, 15 minutes, 30 minutes, 45 minutes and 60 minutes after tourniquet inflation and in PACU as well as POD 1.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date September 1, 2014
Est. primary completion date September 1, 2014
Accepts healthy volunteers No
Gender All
Age group 40 Years to 80 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Blood drawn
Hemoglobin and Hematocrit Levels

Locations

Country Name City State
United States Hospital for Special Surgery New York New York

Sponsors (1)

Lead Sponsor Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary The Hemoglobin (in g/dl) Levels To investigate the effect of intraoperative fluid substitution during HEA on hemoglobin levels during and after primary TKA. up to 48 hours after surgery
Primary Hematocrit (g/dL) Levels To Investigates the effect of intraoperative fluid substitution during HEA on hematocrit levels during and after primary TKA. Up to 48 hours after surgery
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