ClinicalTrials.gov record NCT07743242

Autoimmune Hemolytic Anemia and Its Clinical Implication on Antiphospholipid Syndrome

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Aug 22, 2026

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.

Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.

Age18 years old and older

SexAll

LocationEgypt

AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This interventional diagnostic study enrolls adults with antiphospholipid syndrome to examine autoimmune hemolytic anemia (AIHA). Participants have blood tests (hemoglobin and Coombs) and are grouped as with or without AIHA to compare the number of thrombotic events at baseline. The study is recorded as randomized, single-group, and not masked.

What it is studying. The study aims to define the clinical implications of AIHA in people who have antiphospholipid syndrome (APS). Specifically, it looks at whether AIHA is associated with more thrombotic events and other organ involvement or outcomes in APS patients by performing diagnostic blood tests and comparing groups with and without AIHA.

What the researchers hope to learn. To systematically define the clinical implications of AIHA in APS, including its association with thrombosis, organ involvement, and outcomes; to quantify thrombotic event counts in APS patients with and without AIHA.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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).

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Diagnostic test: Hemoglobin
Coombs test

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

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.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants will give blood samples so researchers can do a hemoglobin test and a Coombs test. The study will use those test results to identify people with autoimmune hemolytic anemia (AIHA) and those without, and will record the number of thrombotic events at baseline. The registry record does not provide details about visit schedules, follow-up, or other procedures.

How the study is structured. This is an interventional (diagnostic) study. According to the record, participants are assigned using randomization, the intervention model is listed as single-group, and there is no masking. All participants have blood drawn for hemoglobin and a Coombs (direct antiglobulin) test. The study compares people identified with AIHA to those without AIHA and records the number of thrombotic events at baseline.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

The registry lists this study under Anti Phospholipid Syndrome. Does it apply to my diagnosis?
The listed sites are in Egypt. Is any of them reachable for me, and does the study help with travel?
Which of the eligibility criteria would need to be checked with tests before I could join?

More on autoimmune hemolytic anemia

Clinical trials49 trials listed for autoimmune hemolytic anemiaEvery trial the registry lists for autoimmune hemolytic anemia, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in autoimmune hemolytic anemia researchLatest monthly update: September 2026. Includes: Negative DAT cases. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start: Jun 5, 2026
Primary completion: Nov 30, 2027 (estimated)
Study completion: Apr 15, 2028 (estimated)
Target enrollment: 230 participants (estimated)
Last updated on registry: Aug 10, 2026
Data verified: Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor: New Valley University
Principal investigator: Asmaa Nady Hussein, Lecturer of Internal Medicine
New Valley University

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Asmaa N Hussein, MD 📞 01065161752 ✉ asmaanady_1010@med.nvu.edu.eg

Participating sites (1)

New Valley UniversityRecruiting
Al Khārjah, Kharga Oasis, 72511 · Egypt
- Asmaa N Hussein, MD · 01065161752 · asmaanady_1010@med.nvu.edu.eg

Terms used on this page · explanations by MedicalUpdates.ai

Informed consent: The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
Inclusion Criteria: The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria: The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this website; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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