NCT03533322

Brief Summary

Gall bladder status among children with chronic haemolytic anemia attending to Assuit University Children Hospital. Hemolysis is defined as the premature destruction of red blood cells (RBCs) (a shortened RBC life span). Anemia results when the rate of destruction exceeds the capacity of the marrow to produce RBCs. Normal RBC survival time is 110-120 days (half-life: 55-60 days), and thus, approximately 0.85% of the most senescent RBCs are removed and replaced each day. Patients with chronic haemolytic anemia are subjected to many complications of chronic haemolytic anemia e.g anemic heart failure, complications of blood transfusion as hepatitis and AIDS, hypersplenism, haemosiderosis ,among them there is incidence of gallbladder stone formation. This work aims to a) to determine the prevalence of gall bladder diseases among patient with chronic haemolytic anemia. b) to determine the risk factors of gall bladder diseases among patients with chronic haemolytic anemia.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2018

Shorter than P25 for all trials

Status
unknown

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

May 11, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 23, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

July 31, 2018

Status Verified

May 1, 2018

Enrollment Period

1 year

First QC Date

May 11, 2018

Last Update Submit

July 29, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • prevelance of gall bladder diseases in children with chronic hemolytic syndrome

    gall bladder diseases

    one year

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All patients admitted to Assiut university children Hospital 1 year study * 2.4.4 -Study tools (in detail, e.g., lab methods, instruments, steps, chemicals, …): Full clinical history including (age of onset of chronic haemolytic anemia- type of chronic haemolytic anemia -frequency of blood transfusion - use of hydroxy urea - splenectomy or not- frequency of admission) * Detailed clinical examination * Abdominal ultrasound * Plain KUB (kidney ureter bladder) x-rayif radiopaque stone. * Compelete blood count * Liver function test * C- reactive protein

You may qualify if:

  • children between 1 :18 years known to have chronic haemolytic anemia.

You may not qualify if:

  • children below 1 year and above 18 years children had past history of cholecystectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Gallbladder Diseases

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System Diseases

Study Officials

  • abelatif abdelmoez, professor

    assiut universitypediatric hospital

    PRINCIPAL INVESTIGATOR
  • shereen galal, assistprof

    assiut universitypediatric hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

shohnda nazeir, master

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Gall bladder status among children with chronic haemolytic anemia attending to Assiut University children hospital

Study Record Dates

First Submitted

May 11, 2018

First Posted

May 23, 2018

Study Start

October 1, 2018

Primary Completion

October 1, 2019

Study Completion

October 1, 2019

Last Updated

July 31, 2018

Record last verified: 2018-05