NCT06708728

Brief Summary

the goal of the study is to identify the most common etiological factors and analyze the clinical presentations and laboratory findings in hospitalized patients with acquired hemolytic anemia associated with non-neoplastic diseases. And to evaluate short-term outcomes, including morbidity and mortality rates, and to determine correlations between specific etiological factors and patient outcomes in these cases.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 27, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

November 27, 2024

Status Verified

November 1, 2024

Enrollment Period

6 months

First QC Date

November 22, 2024

Last Update Submit

November 26, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • intensive care unit admission of the patients due to progression of the disease complications.

    Primary outcome will be ICU admission due to progression of the disease complications.

    through study completion, an average of 6 months

Secondary Outcomes (1)

  • mortality within duration of hospital admission

    through study completion, an average of 6 months

Interventions

blood samples for CBC parameters , peripheral blood smear, bilirubin levels and kidney function tests

Eligibility Criteria

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

patients admitted in Internal Medicine department and Intermediate care unit at sohag university hospital

You may qualify if:

  • Adults aged 18 years and older.
  • Patients diagnosed with acquired hemolytic anemia.
  • Patients must be hospitalized in the Internal Medicine department at the time of diagnosis of acquired hemolytic anemia during the study period
  • Patients (or their legal representatives) must provide informed

You may not qualify if:

  • Patients with underlying neoplastic diseases.
  • Patients with hereditary hemolytic anemia.
  • Patients or their representatives who do not consent to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Sohag University

Sohag, Egypt

Location

MeSH Terms

Conditions

Anemia, Hemolytic

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

AnemiaHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

Mahmoud I Yousef, Lecturer of Internal Medicine

CONTACT

Study Design

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

Study Record Dates

First Submitted

November 22, 2024

First Posted

November 27, 2024

Study Start

December 1, 2024

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

November 27, 2024

Record last verified: 2024-11

Locations