Indices of Severity and Prognosis for Sickle Cell Disease | NCT00005467

Studies
Indices of Severity and Prognosis for Sickle Cell Disease

NCT00005467

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Status

Completed

Last Update Posted

Feb 18, 2016Estimated

Enrollment

Not provided

Phase

Not provided

Conditions

Anemia, Sickle Cell
Blood Disease

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01HL042498	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

May 2000

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1990

Primary Completion Date

Not provided

Completion Date

Dec 1992Actual

First Submitted Date

May 25, 2000

First Submission Date that Met QC Criteria

May 25, 2000

First Posted Date

May 26, 2000Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 17, 2016

Last Update Posted Date

Feb 18, 2016Estimated

Description Module

Brief 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.

Detailed 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Eligibility Module

Eligibility Criteria

No eligibility criteria

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

100 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
8311173	Background	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.

ID	Term
D000755	Anemia, Sickle Cell
D006402	Hematologic Diseases

ID	Term
D000745	Anemia, Hemolytic, Congenital
D000743	Anemia, Hemolytic
D000740	Anemia
D006425	Hemic and Lymphatic Diseases