Validation of a New Standardized Clinical Anemia Evaluati... | NCT00478582

Studies
Validation of a New Standardized Clinical Anemia Evaluation Score Using a Hb Visual Scale in Nephrological Patients

NCT00478582

Sponsor

Insel Gruppe AG, University Hospital Bern

Status

Completed

Last Update Posted

Jan 13, 2011Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Anemia

Interventions

Estimation of Hb concentrations with the HemoHue card

Countries

Switzerland

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

Status Module

Record Verification Date

Jan 2011

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

May 2007

Primary Completion Date

Dec 2007Actual

Completion Date

Dec 2007Actual

First Submitted Date

May 24, 2007

First Submission Date that Met QC Criteria

May 24, 2007

First Posted Date

May 25, 2007Estimated

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

Jan 12, 2011

Last Update Posted Date

Jan 13, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The clinical evaluation of anemia is usually done by examination of the palpebral conjontivae coloration. This appreciation remains crude and largely observer dependent, as no reference scale was successfully proposed,. A Hb visual scale allowing the assessment of the degree of clinical anemia has been developed. Its use has been validated so far in small patient groups in the following settings: blood donation, cardiac surgery, oncology and consultation of general practitioners.

The objective of the present investigation is to validate the use of a Hb visual scale for the clinical evaluation of anemia in patients with kidney disease patients

Detailed Description

Not provided

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Estimation of Hb concentrations with the HemoHue card	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Comparison of visual estimated Hb concentrations with measured Hb concentrations

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with chronich kidney disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dominik Uehlinger, Prof		Study Director
Dominik Uelinger, Prof		Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of nephrology and hypertension, University hospital of berne		Bern	Canton of Bern	3010	Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D000740	Anemia

Ancestor Terms

ID	Term
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided