Intravenous Gammaglobulin for Sickle Cell Pain Crises


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.

Study Start Date

November 2008

Estimated Completion Date

July 2020


  • Drug: Immune Globulin Intravenous
  • Drug: Normal saline


  • Internal Medicine: Hematology/Oncology,Pain Management
  • Oncology: Anemia/Polycythemia,Pain Management/Palliative Care
  • Pain Management: Oncology

MeSH Terms

  • Normal saline
  • Sickle Cell Disease

Study ID

Albert Einstein College of Medicine of Yeshiva University -- 7R01FD003447-03



Trial ID


Study Type


Trial Phase

Phase 1/Phase 2

Enrollment Quota



Albert Einstein College of Medicine of Yeshiva University

Inclusion Criteria

  • Documented diagnosis of sickle cell disease (SS or S-? thalassemia genotype)
  • Age 12-65 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%
  • Known 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
  • Current treatment with chronic transfusion
  • Prior thromboses or current estrogen use




12 Years to 65 Years

Accepts Healthy Volunteers


Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
Montefiore Medical Center - Bronx, New York 40.3 miles Deepa G Manwani MD 718-741-2342 provides clinical trial listings in an easy to view format. All clinical trial information is pulled directly from This website does not guarantee acceptance into any clinical trial, and is not responsible for adverse events that may be incurred from a clinical trial.