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One Year Hospital Data Patients With AIHA in Assiut University Hospital - Clinical Hematology Unit

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ClinicalTrials.gov Identifier: NCT03269292
Recruitment Status : Unknown
Verified August 2017 by Ehab A. Abdelmenam, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : August 31, 2017
Last Update Posted : August 31, 2017
Sponsor:
Information provided by (Responsible Party):
Ehab A. Abdelmenam, Assiut University

Brief Summary:
Autoimmune hemolytic anemia is characterized by shortened red blood cell survival and a positive Coombs test. The responsible autoantibodies may be either warm reactive or cold reactive. The rate of hemolysis and the severity of the anemia may vary from mild to severe and life-threatening. Diagnosis is made in the laboratory by the findings of anemia, reticulocytosis, a positive Coombs test, and specific serologic tests. The prognosis is generally good but renal failure and death sometimes occur, especially in cases mediated by drugs.

Condition or disease
Autoimmune Hemolytic Anemia

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: One Year Hospital Data Patients With Autoimmune Hemolytic Anaemia in Assiut University Hospital - Clinical Hematology Unit
Estimated Study Start Date : October 1, 2017
Estimated Primary Completion Date : September 1, 2018
Estimated Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. total number of adverse events [ Time Frame: 6 months from baseline ]
    the primary safety endpoints of the study are the incidence and the severity of treatment emergent adverse events following administration of steroids ,cyclophosphamide , rituximab

  2. Change from baseline in hemoglobin [ Time Frame: 6 months from baseline ]
    Efficacy endpoint assesment


Secondary Outcome Measures :
  1. Dose of steroid treatment [ Time Frame: 5 day , 20 days , 40 days , 61 days , 63 days , 6 months after steroids inclusion ]
    effect of cyclophosphamide , rituximab administration on steroid dose



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients above 18 years and under 75 years diagnosed AIHA in assiut university hospital
Criteria

Inclusion Criteria:

patients diagnosed auto Immune hemolytic anaemia primary or secondary(CLL, Lymphoma , rheumatoid arthritis

, SLE ,Drug induced ) from 10/2017 to 10/18

Exclusion Criteria:

  1. All types of congenital hemolytic anaemia
  2. Microangiopathic hemolytic anaemia ( Thrombotic thrombocytopenic purpura (TTP) , Hemolytic-uremic syndrome (HUS) , Disseminated intravascular coagulation (DIC) )
  3. Alloimmune hemolytic anaemia
  4. pregnancy

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): NCT03269292


Contacts
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Contact: ehab ahmed abdel menam 201141587651 ehabahmed200@gmail.com

Sponsors and Collaborators
Assiut University
Investigators
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Study Director: Essam Abdel Monem El-beih, profeesor Assiut University
Principal Investigator: wael ahmed abbas, profeesor Assiut University

Publications of Results:
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Responsible Party: Ehab A. Abdelmenam, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03269292     History of Changes
Other Study ID Numbers: AIHA in assiut
First Posted: August 31, 2017    Key Record Dates
Last Update Posted: August 31, 2017
Last Verified: August 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anemia
Anemia, Hemolytic
Anemia, Hemolytic, Autoimmune
Hemolysis
Hematologic Diseases
Pathologic Processes
Autoimmune Diseases
Immune System Diseases