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Phase 3
6 Months
18 Years
Not Enrolling
Hemolytic Uremic Syndrome

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Trial Information

PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study.
Patients are randomized to receive either SYNSORB Pk or placebo.

Patients receive oral SYNSORB Pk or placebo three times daily for 7 days. Patients are
followed on days 7, 14, 28, and 60 after discharge from the hospital.

Inclusion Criteria


--Disease Characteristics--

- Clinically diagnosed E. coli-associated diarrhea-associated hemolytic uremic syndrome

- Diarrheal prodrome within 7 days before onset of disease

- No HUS associated with the following: Hereditary Post-bone marrow transplantation
Streptococcus pneumoniae infection

- No prior catastrophic complications

--Patient Characteristics--

- Hematopoietic: Thrombocytopenia less than 140,000/mm3 Fragmented red blood cells

- Renal: Renal involvement (hematuria, proteinuria, or azotemia) No underlying
glomerular disease

- Other: HIV negative No pre-existing structural abnormality or dysmotility syndrome of
the gastrointestinal tract No inflammatory bowel disease (e.g., Crohn's disease,
ulcerative colitis)

Type of Study:


Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment

Principal Investigator

Howard Trachtman

Investigator Role:

Study Chair

Investigator Affiliation:

Long Island Jewish Medical Center


United States: Federal Government

Study ID:




Start Date:

July 1998

Completion Date:

Related Keywords:

  • Hemolytic Uremic Syndrome
  • E. coli infection
  • bacterial infection
  • hemolytic uremic syndrome
  • immunologic disorders and infectious disorders
  • rare disease
  • renal and genitourinary disorders
  • Hemolytic-Uremic Syndrome
  • Azotemia
  • Hemolysis



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Indiana University Cancer Center Indianapolis, Indiana  46202-5265
State University of New York Health Sciences Center - Stony Brook Stony Brook, New York  11790-7775
Boston Floating Hospital Infants and Children Boston, Massachusetts  02111
New York Medical College Valhalla, New York  10595
St. Barnabas Medical Center Livingston, New Jersey  07039
North Shore University Hospital Manhasset, New York  11030
University of Rochester Medical Center Rochester, New York  14642
Children's Hospital of Denver Denver, Colorado  80218
Children's Hospital of Pittsburgh Pittsburgh, Pennsylvania  15213
West Virginia University Hospitals Morgantown, West Virginia  26506-9300
Weill Medical College of Cornell University New York, New York  10021
Alfred I. Dupont Institute Wilmington, Delaware  19899
Maimonides Medical Center Brooklyn, New York  11219
Children's Hospital of the King's Daughters Norfolk, Virginia  23507
Long Island Jewish Medical Center New Hyde Park, New York  11040
Emory University School of Medicine Atlanta, Georgia  30322
Robert Wood Johnson Medical School New Brunswick, New Jersey  08903
Medical College of Georgia Hospital and Clinics Augusta, Georgia  30912-3620
Children's Hospital at St. Joseph's Patterson, New Jersey  07503
Jack D. Weiler Hospital of the Albert Einstein College of Medicine Bronx, New York  10461
Children's Hospital of Buffalo Buffalo, New York  14222
Ohio State University Children's Hospital Columbus, Ohio  43205-2696
University of Virginia Charlottesville, Virginia  22908
University of Wisconsin Children's Hospital Madison, Wisconsin  53792-4108