Intravenous Gammaglobulin for Sickle Cell Pain Crises

Description

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

Interventions

  • Drug: Immune Globulin Intravenous
  • Drug: Normal saline

Specialties

  • 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

Status

Unknown

Trial ID

NCT01757418

Study Type

Interventional

Trial Phase

Phase 1/Phase 2

Enrollment Quota

94

Sponsor

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

Gender

Both

Ages

12 Years to 65 Years

Accepts Healthy Volunteers

No

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 dmanwani@montefiore.org

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