NCT04139265

Brief Summary

Transferrin saturation coefficient and ferritinemia in diagnosis of iron deficiency

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 6, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

October 23, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 25, 2019

Completed
Last Updated

October 25, 2019

Status Verified

October 1, 2019

Enrollment Period

4 months

First QC Date

October 23, 2019

Last Update Submit

October 23, 2019

Conditions

Iron-deficiencyInternal MedicineTransferrinFerritinemia

Outcome Measures

Primary Outcomes (1)

  • Agreement between Transferrin Saturation Coefficient (TSC) and ferritinemia dosage

    The overall agreement, assessed by kappa Cohen

    Day one

Secondary Outcomes (3)

  • Prevalence of iron deficiency with and without anaemia

    Day one

  • Prevalence of etiologies of iron deficiency

    Day one

  • Prevalence of iron deficiency in patients with anticoagulant and platelet aggregation inhibitor

    Day one

Study Arms (1)

Hospitalized patients aged 65 and over

\- Patients aged 65 and over hospitalized in the department of Internal Medicine and Geriatry

Diagnostic Test: biologic analysis (ferritinemia, transferrin saturation coefficient)

Interventions

biologic analysis (ferritinemia, transferrin saturation coefficient)DIAGNOSTIC_TEST

Each patient will follow a blood test in order to compare between ferritinemia and transferrin saturation coefficient in iron deficiency diagnosis

Hospitalized patients aged 65 and over

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Elderly people hospitalized in the internal medicine and geriatry service

You may qualify if:

  • ≥ 65 years old
  • Patient hospitalized in the internal medicine and geriatry service
  • Patient affiliated with a social security scheme
  • Patient signed an Informed consent

You may not qualify if:

  • Risk benefit balance not in favor of iron deficiency check-up
  • Patient in palliative care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint-Philibert hospital

Lomme, Nord, 59462, France

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Anemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Hélène Bulckaen, MD

    Groupement des Hôpitaux de l'Institut Catholique de Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2019

First Posted

October 25, 2019

Study Start

June 6, 2019

Primary Completion

September 30, 2019

Study Completion

September 30, 2019

Last Updated

October 25, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)