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NCT Number: NCT07743242

Autoimmune Hemolytic Anemia and Its Clinical Implication on Antiphospholipid Syndrome

AIHA is a heterogeneous autoimmune cytopenia with variable severity and significant morbidity. APS is defined by thrombosis and/or obstetric morbidity with persistent antiphospholipid antibodies (aPL).

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Key information

Conditions

Anti Phospholipid Syndrome Antiphospholipid Syndrome Autoimmune Diseases Immune System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New Valley University

Al Khārjah, Kharga Oasis, 72511, Egypt

Location status: Recruiting

Location contact

Asmaa N Hussein, MD

CONTACT

[email protected]

01065161752

About this study

AIHA occurs in ~10-12% of APS cohorts and is associated with arterial thrombosis, cardiac valve disease, livedo reticularis, epilepsy/chorea, and a more severe APS phenotype.

APS patients hospitalized with AIHA have markedly higher venous thromboembolism (VTE) risk (OR ≈ 8.6) compared with AIHA without APS.

Hematologic APS (AIHA ± thrombocytopenia) may precede or coexist with thrombotic/obstetric APS, depending on aPL profile.

There is a need to systematically define the clinical implications (thrombosis, organ involvement, outcomes) of AIHA in APS.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged ≥18 years
  • Patients with anemia consistant with hemolysis.
  • Patient diagnosed with antiphospholipid syndrome.
  • Informed consent obtained

Exclusion criteria

  • Age less than 18 years.
  • Other causes of anemia than autoimmune hemolysis.

Treatment and study plan

Hemoglobin

Diagnostic Test

Blood sample

Coombs test

Diagnostic Test

Blood sample

Primary outcomes

  1. Number of thrombotic events in APS patients with AIHA

    Time frame: baseline

Secondary outcomes

  1. Number of thrombotic events in APS patients aithout AIHA

    Time frame: baseline

Study contacts

Contact information is provided by the study sponsor or research team.

Asmaa N Hussein, MD

CONTACT

[email protected]

01065161752

Sponsors and collaborators

Lead sponsor

New Valley University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Aug 3, 2026
Registry last updated
Aug 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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