Intravenous Gammaglobulin for Sickle Cell Pain Crises



Status:Completed
Conditions:Anemia
Therapuetic Areas:Hematology
Healthy:No
Age Range:Any
Updated:11/18/2012
Start Date:November 2008
End Date:October 2012
Contact:Patricia A Shi, MD
Email:patricia.shi@mssm.edu
Phone:212-241-9237

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Treatment of Sickle Cell Vaso-Occlusive Crises With High-Dose Intravenous Gammaglobulin


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.


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.

Inclusion Criteria:

- Documented diagnosis of sickle cell disease (SS or S-β thalassemia genotype)

- Age 8-65 years

- Uncomplicated acute pain episode requiring hospital admission and parenteral
narcotics

Exclusion Criteria:

- Increased stroke risk as assessed by transcranial Doppler or magnetic resonance
imaging (all subjects undergo testing)

- Concomitant acute process, including fever > 38.5° C with clinical suspicion of
infection

- Increased ALT > 2X ULN

- Serum creatinine ≥1.3 mg/dL, >300 mg/dL protein in spot urinalysis, or known
condition associated with renal dysfunction

- Hb > 10 g/dL and Hct > 30%

- IgA deficiency or known allergy to gamma globulin

- Pregnancy or breastfeeding

- Vaccination with a live attenuated virus in the preceding 6 weeks

- Documented history of illicit (eg. heroin, cocaine) drug abuse or drug-seeking
behavior

- Current participation in another investigational drug study

- Previous participation in this study within last 3 months

- Current treatment with chronic transfusion
We found this trial at
2
sites
3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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1 Gustave L Levy Pl # 504
New York, New York 10029
 (212) 241-6500
Mount Sinai School of Medicine Icahn School of Medicine at Mount Sinai is proud to...
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New York, NY
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