The Effect of Hypotensive Anesthesia on Hemoglobin Levels During Total Knee Arthroplasty

NCT05340751 | Completed Results

• 1 other identifier: 2015-081
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anesthesia

Keywords

Blood management; Blood transfusion; Hemoglobin; Hypotensive Anesthesia; Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Anesthesia

hemoglobin

Diagnostic Test: Blood drawn

Interventions

Blood drawn DIAGNOSTIC_TEST

Hemoglobin and Hematocrit Levels

Anesthesia

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients scheduled for primary total knee arthroplasty who meet the qualifications will be consented prior to the surgery.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Results Point of Contact

• Title: Dr. Friedrich Boettner
• Organization: Hospital for Special Surgery

BoettnerF@hss.edu

2127742127

Study Officials

• Friedrich Boettner, MD

  Associate Professor of Orthopaedic Surgery

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2018
• First Posted: April 22, 2022
• Study Start: January 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: January 26, 2023
• Results First Posted: January 26, 2023

Record last verified: 2022-04

Locations

US (1)