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NCT00005467 Clinical Trial

Indices of Severity and Prognosis for Sickle Cell Disease

Anemia, Sickle Cell Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00005467
Other study ID # 4912
Secondary ID R01HL042498
Status Completed
Phase N/A
First received May 25, 2000
Last updated February 17, 2016
Start date January 1990
Est. completion date December 1992

Study information
Verified date May 2000
Source National Heart, Lung, and Blood Institute (NHLBI)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

To develop a clinical severity index that could prospectively identify sickle cell disease patients who were at high risk for a turbulent clinical course and a poor prognosis.

Description:

DESIGN NARRATIVE:

Using the database, univariate analysis showed that factors associated with the occurrence of cerebrovascular accident (51 patients) included hematocrit, rate of change of pocked red cell count, and polymer fraction at 40 percent oxygen saturation (PF40). Only low hematocrit was predictive of death in the pediatric cohort. There were 45 disease-related deaths.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date December 1992
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group N/A to 100 Years
Eligibility No eligibility criteria

Study Design

N/A

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

References & Publications (1)

Bray GL, Muenz L, Makris N, Lessin LS. Assessing clinical severity in children with sickle cell disease. Preliminary results from a cooperative study. Am J Pediatr Hematol Oncol. 1994 Feb;16(1):50-4. — View Citation

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