NCT03269292

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 31, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2021

Completed
Last Updated

April 14, 2021

Status Verified

April 1, 2021

Enrollment Period

3.3 years

First QC Date

August 28, 2017

Last Update Submit

April 11, 2021

Conditions

Autoimmune Hemolytic Anemia

Outcome Measures

Primary Outcomes (2)

  • Change from baseline in hemoglobin

    Efficacy endpoint assesment

    three week from baseline

  • frequency of drug-related side effects

    safety endpoint

    three week from base line

Secondary Outcomes (1)

  • Dose of steroid treatment

    at 3 weeks, three months, six month, one year from baseline

Study Arms (1)

warm autoimmune hemolytic anemia

corticosteroid either oral form or intravenous followed by oral

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients above 18 years or more diagnosed AIHA at Assiut university hospital

You may qualify if:

  • patients diagnosed warm auto Immune hemolytic anemia primary or secondary(CLL, Lymphoma, rheumatoid arthritis
  • , SLE,Drug-induced )

You may not qualify if:

  • All types of congenital hemolytic anemia
  • Microangiopathic hemolytic anemia ( Thrombotic thrombocytopenic purpura (TTP) , Hemolytic-uremic syndrome (HUS) , Disseminated intravascular coagulation (DIC) )
  • Alloimmune hemolytic anemia
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University Hospital

Asyut, Egypt

Location

Related Publications (7)

  • Packman CH. The Clinical Pictures of Autoimmune Hemolytic Anemia. Transfus Med Hemother. 2015 Sep;42(5):317-24. doi: 10.1159/000440656. Epub 2015 Sep 11.

    PMID: 26696800RESULT

  • Dhingra KK, Jain D, Mandal S, Khurana N, Singh T, Gupta N. Evans syndrome: a study of six cases with review of literature. Hematology. 2008 Dec;13(6):356-60. doi: 10.1179/102453308X343518.

    PMID: 19055865RESULT

  • Garratty G. Immune hemolytic anemia associated with negative routine serology. Semin Hematol. 2005 Jul;42(3):156-64. doi: 10.1053/j.seminhematol.2005.04.005.

    PMID: 16041665RESULT

  • Kamesaki T, Oyamada T, Omine M, Ozawa K, Kajii E. Cut-off value of red-blood-cell-bound IgG for the diagnosis of Coombs-negative autoimmune hemolytic anemia. Am J Hematol. 2009 Feb;84(2):98-101. doi: 10.1002/ajh.21336.

    PMID: 19105232RESULT

  • Zanella A, Barcellini W. Treatment of autoimmune hemolytic anemias. Haematologica. 2014 Oct;99(10):1547-54. doi: 10.3324/haematol.2014.114561.

    PMID: 25271314RESULT

  • Michel M. [Characteristics of warm autoimmune hemolytic anemia and Evans syndrome in adults]. Presse Med. 2008 Sep;37(9):1309-18. doi: 10.1016/j.lpm.2008.01.026. Epub 2008 Jul 17. French.

    PMID: 18644324RESULT

  • Salama A. Treatment Options for Primary Autoimmune Hemolytic Anemia: A Short Comprehensive Review. Transfus Med Hemother. 2015 Sep;42(5):294-301. doi: 10.1159/000438731. Epub 2015 Aug 10.

    PMID: 26696797RESULT

MeSH Terms

Conditions

Anemia, Hemolytic, Autoimmune

Condition Hierarchy (Ancestors)

Anemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Essam Abdel Monem El-beih, professor

    Assiut University

    STUDY DIRECTOR

  • wael ahmed abbas, professor

    Assiut University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 28, 2017

First Posted

August 31, 2017

Study Start

October 1, 2017

Primary Completion

January 24, 2021

Study Completion

January 24, 2021

Last Updated

April 14, 2021

Record last verified: 2021-04

Locations

EG(1)