Study of Acquired Hemolytic Anemia in Adult Hospitalized... | NCT06708728

Studies
Study of Acquired Hemolytic Anemia in Adult Hospitalized Patients

NCT06708728

Sponsor

Sohag University

Status

Not yet recruiting

Last Update Posted

Nov 27, 2024Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Hemolytic Anemia

Interventions

blood samples

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2024Estimated

Primary Completion Date

Jun 2025Estimated

Completion Date

Jun 2025Estimated

First Submitted Date

Nov 22, 2024

First Submission Date that Met QC Criteria

Nov 26, 2024

First Posted Date

Nov 27, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 26, 2024

Last Update Posted Date

Nov 27, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
blood samples	Other	blood samples for CBC parameters , peripheral blood smear, bilirubin levels and kidney function tests

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
mortality within duration of hospital admission	Secondary outcome will be mortality within duration of hospital admission	through study completion, an average of 6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ahmed E Mahmoud	Contact	02 01145943157		ahmed.elsayed95@med.sohag.edu.eg
Mahmoud I Yousef, Lecturer of Internal Medicine	Contact	02 0106 596 4083

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine Sohag University		Sohag			Egypt

Condition Browse Module

MeSH Terms

ID	Term
D000743	Anemia, Hemolytic

Ancestor Terms

ID	Term
D000740	Anemia
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided