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Intravenous Gammaglobulin for Sickle Cell Pain Crises

2014-08-27 03:31:53 | BioPortfolio

Summary

The purpose of this study is to determine whether intravenous immune globulin is effective in the acute treatment of pain crises in sickle cell disease.

Description

This is a randomized, double-blind, placebo-controlled, dose-escalation Phase I-II trial to study the safety and efficacy of a single dose of IVIG compared to normal saline placebo administered to patients with sickle cell anemia admitted to the hospital with an uncomplicated acute pain episode. A total of 52 subjects will be enrolled. The hypothesis is that IVIG will act quickly to reduce vaso-occlusion and thus pain scores, narcotic use, and length of hospitalization. The physiological effects of IVIG in patients with sickle cell disease will also be evaluated by measuring the adhesion receptors involved in leukocyte adherence to endothelium and red blood cell-leukocyte interactions, microcirculatory blood flow, and serum markers of hemolysis.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Conditions

Sickle Cell Anemia

Intervention

Immune Globulin Intravenous

Location

Mount Sinai School of Medicine
New York
New York
United States
10029

Status

Recruiting

Source

Shi, Patricia, M.D.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:31:53-0400

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