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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.

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ClinicalTrials.gov Identifier: NCT02129907
Recruitment Status : Completed
First Posted : May 2, 2014
Last Update Posted : December 18, 2018
Sponsor:
Information provided by (Responsible Party):
Elias mazen, HaEmek Medical Center, Israel

Brief Summary:

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


Condition or disease
Iron Deficiency Anemias

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Study Type : Observational [Patient Registry]
Actual Enrollment : 82 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 10 Weeks
Official Title: 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.
Study Start Date : October 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron




Primary Outcome Measures :
  1. thrombin generation levels [ Time Frame: 10 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
men and women over age 18 suffering from iron deficiency anemia that wasnt responded to oral iron treatment or there is contraindication for oral iron therapy.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02129907


Locations
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Israel
Haemek medical center
Afula, Israel, 1834111
Sponsors and Collaborators
HaEmek Medical Center, Israel

Additional Information:

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Responsible Party: Elias mazen, prof mazen elias, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT02129907     History of Changes
Other Study ID Numbers: thrombingeneration- anemia
First Posted: May 2, 2014    Key Record Dates
Last Update Posted: December 18, 2018
Last Verified: December 2015

Keywords provided by Elias mazen, HaEmek Medical Center, Israel:
Anemias
Iron-Deficiency
thrombin

Additional relevant MeSH terms:
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Anemia
Anemia, Iron-Deficiency
Deficiency Diseases
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Malnutrition
Nutrition Disorders
Thrombin
Hemostatics
Coagulants