Skip to main content
OpenTrials
Completed

NCT Number: NCT02148809

Blood Volume Analysis of Total Hip Arthroplasty Patients Under Hypotensive Anesthesia

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital for Special Surgery

New York, 10021, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

1mL of I-131 Human Serum Albumin is injected prior to the measurements

Radiation

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
May 28, 2014
Registry last updated
Jun 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.