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.

December 17, 2018 updated by: Elias mazen, HaEmek Medical Center, Israel

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

82

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Afula, Israel, 1834111
        • Haemek Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
thrombin generation levels
Time Frame: 10 weeks
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HaEmek Medical Center, Israel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

May 1, 2014

First Submitted That Met QC Criteria

May 1, 2014

First Posted (Estimate)

May 2, 2014

Study Record Updates

Last Update Posted (Actual)

December 19, 2018

Last Update Submitted That Met QC Criteria

December 17, 2018

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • thrombingeneration- anemia

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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