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Blood Volume Analysis of Total Hip Arthroplasty Patients Under Hypotensive Anesthesia

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ClinicalTrials.gov Identifier: NCT02148809
Recruitment Status : Completed
First Posted : May 28, 2014
Results First Posted : June 14, 2017
Last Update Posted : June 14, 2017
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

Study Description
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Brief Summary:

Hypotensive Anesthesia is a type of regional anesthesia performed routinely at our hospital. This type of anesthesia reduces the average arterial pressure. Benefits include reduced bleeding and lower risk of blood clots.

The purpose of this study is to determine the effect of intravenous fluids administered with hypotensive anesthesia on your blood volume. With this parameter we will be able to understand how much of your blood is lost because of bleeding and how much of the drop is related to dilution.

Study hypothesis: Hemodilution associated with intravenous fluid substitution during hypotensive anesthesia results in decreased postoperative hemoglobin (Hb) levels


Condition or disease Intervention/treatment Phase
Blood Volume Analysis Radiation: 1mL of I-131 Human Serum Albumin is injected prior to the measurements Not Applicable

Detailed Description:
Recent technology allows the measurement of patients' total blood volume with 98% accuracy within 90 minutes or less. This is key to understanding the effect of hypotensive anesthesia on patients undergoing total hip arthroplasty. The drop in blood pressure enhances the dilutional effect of intravenous fluid given during the procedure. Increases in TBV could result in decreases of postoperative hemoglobin. Understanding the effect of hypotensive anesthesia on postoperative hemoglobin levels and TBV will enhance our understanding of postoperative blood management and transfusion triggers.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Blood Volume Analysis of Total Hip Arthroplasty Patients Under Hypotensive Anesthesia
Actual Study Start Date : May 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Blood Volume Analysis, Fluid
Preop I-131 is given and the BVA is performed, 6 hours after surgery the same procedure will be done to compare the TBV at both points
 Radiation: 1mL of I-131 Human Serum Albumin is injected prior to the measurements


Outcome Measures
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Primary Outcome Measures :
  1. Change in Total Blood Volume [ Time Frame: preoperatively and 6 hours postoperatively ]
    The primary outcome is the change in total blood volume (TBV) during the first 6 hours after primary THA utilizing hypotensive anesthesia. Preoperative TBV will be compared to values 6 hours postoperatively.


Other Outcome Measures:
  1. Change IN Plasma Volume PV [ Time Frame: preoperative and 6 hours postoperatively ]

    An indicator dilution technique was used to measure the blood volume, plasma volume and red cell blood volume. Approved by the Food and Drug Administration in 1998, the BVA-100 blood volume analyzer (Daxor Corp.) is a semi-automated system for blood volume analysis. Prepared standards and injectates were used. The injectate consists of 31I-labeled HSA (370- 1,295 kBq [10-30 mCi]) in saline.

    Measurement was performed directly before surgery in the holding area and 6 hours after surgery.

    Each time, before injection of the tracer a baseline sample was taken. After injection of the tracer via standard i.v. line, the first sample was drawn from an arterial line after 12 minutes waiting time. Afterwards every 6 minutes a sample was taken. In a whole 5 samples were sent for analysis to Daxor® Corp.. Each sample is counted in duplicate.



Eligibility Criteria
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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Non- inflammatory degenerative joint disease of the hip
  • Patients scheduled for unilateral primary total hip arthroplasty
  • Age between 50 and 75 years
  • Hypotensive Spinal-epidural anesthesia with systolic BP < 95 and diastolic BP < 65.
  • Adequate intraoperative fluid loading: a minimum of 3 L within 6 hours of surgery

Exclusion Criteria:

  • Pregnant women or nursing mothers.
  • Women of childbearing potential not using adequate birth control methods
  • Known hypersensitivity to I-131 albumin or any other component of the Volumex injection kit
  • 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 Hip Surgery
  • Inadequate intravenous fluid substitution within the first 6 hrs (<3 liters)
  • Inadequate hypotensive anesthesia (mean arterial pressure above 65 for more than 33% of the surgical time
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02148809


Locations
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United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
Sponsors and Collaborators
Hospital for Special Surgery, New York
More Information
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Publications:

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Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT02148809    
Other Study ID Numbers: IRB # 13193
First Posted: May 28, 2014    Key Record Dates
Results First Posted: June 14, 2017
Last Update Posted: June 14, 2017
Last Verified: May 2017