Intravenous Gammaglobulin for Sickle Cell Pain Crises
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- STATUS
- Recruiting
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- participants needed
- 56
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- sponsor
- Shi, Patricia, M.D.
Summary
The purpose of this study is to determine whether intravenous immune globulin is safe and 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 56 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.
Details
| Condition | Sickle Cell Anemia |
|---|---|
| Treatment | Immune Globulin Intravenous |
| Clinical Study Identifier | NCT00644865 |
| Sponsor | Shi, Patricia, M.D. |
| Last Modified on | 7 November 2020 |
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