NCT00338234

Brief Summary

Anemia in intensive care and post-operative patients is due to both blood loss (leading to iron loss) and inflammation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
153

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2006

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

June 16, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 20, 2006

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

May 6, 2008

Status Verified

April 1, 2007

Enrollment Period

1.5 years

First QC Date

June 16, 2006

Last Update Submit

May 5, 2008

Conditions

AnemiaIntensive CareCardiac Surgery

Keywords

anemiaintensive carecardiac surgeryiron metabolismhepcidin

Outcome Measures

Primary Outcomes (1)

  • Functional iron deficiency

    during the study

Secondary Outcomes (1)

  • fatigue assessed by the MFI20 score for cardiac surgery patients

    at one day,at seven days and at 28 days

Study Arms (2)

Cardiac surgery

Successive cardiac surgery patients

Surgical ICU

Successive patients admitted to the surgical ICU for more than 7 days, and experiencing anemia

Eligibility Criteria

Age20 Years - 88 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

* For the surgery :population 20 yers to 88 years old * For the reanimation : population to the 41 years to 85 years old

You may qualify if:

  • Anemia (haemoglobin \< 10 g/dL)
  • Hospitalization in ICU for an expected duration of 7 days or more
  • Or, day one post cardiac surgery

You may not qualify if:

  • Chronic anemia (Hb \< 9 g/dL for more than one month before hospitalization)
  • Iron metabolism disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

APHP, hopital Bichat

Paris, 75018, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood serum

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • sigismond lasocki, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

  • Carole Beaumont, PhD

    Institut National de la Santé Et de la Recherche Médicale, France

    STUDY CHAIR

  • Isabelle Boutron, MD

    Institut National de la Santé Et de la Recherche Médicale, France

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 16, 2006

First Posted

June 20, 2006

Study Start

June 1, 2006

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

May 6, 2008

Record last verified: 2007-04

Locations

FR(1)