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OpenTrials
Completed

NCT Number: NCT02129907

The Purpose of the Study is to Examine Whether Iron Deficiency Anemia is Associated With Increased Production of Thrombin and Whether Correction of Anemia by Providing Iron Intravenously Causes a Significant Reduction in Production of Thrombin.

In total 50 subjects with iron deficiency anemia treated with intravenous iron are planned for inclusion in this trial. After signing an informed consent a blood sample will be obtained from each participant before iron treatment. The investigators will measure the thrombin generation in plasma assessed by the calibrated automated thrombogram (CAT). patient will go face to face interview and will be asked to answer structured questionnaire which will include information on demographics, clinical data ( fever, allergies , etc.) and comorbidities

Two weeks after completing intravenous iron administration additional blood samples will be taken: thrombin generation will be measured

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Key information

Conditions

Iron Deficiency Anemias Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Haemek medical center

Afula, 1834111, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age >18 years
  • Iron deficiency anemia that did not response to oral iron treatment and is planned to receive iron supplement intravenously.
  • Signing the informed consent

Exclusion criteria

  • chronic inflammatory disease
  • renal failure
  • Malignancy
  • Infectious disease
  • Other reason for anemia except iron deficiency anemia.
  • Pregnant women
  • Use of anti aggregating agents or anticoagulants

Treatment and study plan

Primary outcomes

  1. thrombin generation levels

    Time frame: 10 weeks

Sponsors and collaborators

Lead sponsor

HaEmek Medical Center, Israel

Other

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
May 2, 2014
Registry last updated
Dec 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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