Microvascular Blood Flow in Sickle Cell Anemia

Summary

Sickle cell disease (SCD) is an inherited blood disorder that causes the red blood cells to change their shape from a round shape to a half-moon/crescent or sickled shape. Sickle-shaped cells can cause problems by getting stuck in blood vessels, blocking blood flow, and can cause inflammation and injury to important body parts. There are no specific treatments that improve this condition and promote blood flow hindered by sickle cell blockages. Another big challenge in managing sickle cell disease is that there are no good measures to determine changes and improvements in blood flow.

Contrast-enhanced ultrasound is a technique currently used to detect blood flow in the heart, muscles, and other organs. It is extremely sensitive and can detect blood flow in the smallest of blood vessels. It would be very useful in helping healthcare providers know whether treatment strategies are improving blood flow during sickle cell blockages.

The hypothesis is that contrast-enhanced ultrasound will be a feasible tool for determining changes in blood flow of subjects with sickle cell disease.

Conditions

• Sickle Cell Disease
• Sickle Cell Anemia

Interventions

DRUG

regadenoson infusion with contrast-enhanced ultrasound

Subjects who are not having a pain crisis receive a 24-hour infusion of regadenoson. Contrast-enhanced ultrasound will be performed four times during the 24 hour regadenoson infusion

PROCEDURE

contrast-enhanced ultrasound

Subjects who are not having a pain crisis will have contrast-enhanced ultrasound performed up to four times over a two-day period. Time points will resemble the time course used for the Regadenoson Arm, although no investigational drug will be given.

PROCEDURE

contrast-enhanced ultrasound

Contrast-enhanced ultrasound will be performed on adults with sickle cell anemia at baseline who are not having a pain crisis and performed again during a pain crisis

PROCEDURE

contrast-enhanced ultrasound

Contrast-enhanced ultrasound will be performed on healthy control subjects at baseline, on the first day of the study and 30 days later

PROCEDURE

contrast-enhanced ultrasound

Contrast-enhanced ultrasound will be performed on healthy volunteers (Technique Optimization Controls)

Sponsors & Collaborators

• Medical College of Wisconsin

  collaborator OTHER

• La Jolla Institute for Allergy & Immunology

  collaborator OTHER

• University of Illinois at Chicago

  collaborator OTHER

• Oregon Health and Science University

  collaborator OTHER

• Dana-Farber Cancer Institute

  collaborator OTHER

• Versiti

  lead OTHER

Principal Investigators

• Joshua J Field, MD, MS · Medical College of Wisconsin

• Jonathon Lindner, MD · Oregon Health and Sciences University

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2012-07-31

Primary Completion

2019-07-05

Completion

2020-11-16

Countries

• United States

Study Locations