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Pilot Validation of a Hemodilution Technique to Estimate Blood Volume in Vivo

NCT03031600 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2017-01-26

No results posted yet for this study

Summary

The objective of this study is to determine the accuracy of estimating patient blood volume using field-expedient point-of-care measurement of hematocrit before and after hemodilution with a standardized volume of intravenous solution, in comparison to determining patient blood volume by radiodilution. A total of 33 healthy adult male subjects aged 18-35 years will undergo determination of blood volume in a fixed order: first by radiodilution, then by hemodilution. Blood volume as measured by radiodilution will be correlated with blood volume as estimated with hemodilution to assess the potential validity of hemodilution as means of estimating blood volume.

Conditions

  • Hypovolemia
  • Hypervolemia

Interventions

DIAGNOSTIC_TEST

Radiodilution via Daxor BVA-100

The BVA-100 measures the hematocrit and residual plasma radioactivity of each sample in a semi-automated process, and the residual radioactivity is compared from that of the pre-injection sample to determine plasma volume. The plasma volume and BVA-100-measured hematocrit are then used to calculate the red cell volume and actual blood volume. The BVA-100 is FDA approved for blood volume measurement in vivo, has a reported precision of ± 2.5%, and has demonstrated accuracy and specificity in blood volume assessment in clinical and research settings (Van, P.Y., et al., 2011, Borovka, M., et al., 2013).

DIAGNOSTIC_TEST

Hemodilution via hematocrit measurement

Hemodilution uses the ideal blood volume and serial hematocrit measures drawn before and after administration of a known quantity of IV fluid to estimate blood volume. Ideal blood volume is calculated using the methods described by Feldschuh and colleagues (Feldschuh, J. and Y. Enson, 1977; Feldschuh, J. and S. Katz, 2007). Hematocrit is measured using the Abbot iSTAT point of care testing device and the lab. Urine output is measured in ml. The ideal blood volume, pre and post-bolus hematocrit, fluid bolus volume, and urine output will be used to calculate estimated blood volume using a mathematical model previously described by the investigators (D'Angelo, M., et al., 2015).

Sponsors & Collaborators

  • Duke University

    collaborator OTHER

  • Henry M. Jackson Foundation for the Advancement of Military Medicine

    collaborator OTHER

  • Uniformed Services University of the Health Sciences

    lead FED

Principal Investigators

  • Kenneth A Wofford, PhD · Uniformed Services University of the Health Sciences

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-05-01
Primary Completion
2018-05-31
Completion
2018-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03031600 on ClinicalTrials.gov