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.

NCT02129907 | Completed DMC

• 1 other identifier: thrombingeneration- anemia
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 1

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

Conditions

Iron Deficiency Anemias

Keywords

Anemias; Iron-Deficiency; thrombin

Outcome Measures

Primary Outcomes (1)

• thrombin generation levels

  10 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead

Study Sites (1)

Haemek medical center

Afula, 1834111, Israel

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Anemia

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof mazen elias

Study Record Dates

• First Submitted: May 1, 2014
• First Posted: May 2, 2014
• Study Start: October 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 19, 2018

Record last verified: 2015-12

Locations

IL (1)