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Status unknownNCT01764971Updated Jan 10, 2013

Cerebral Dysfunction in Chronic ITPwith High Risk of Serious Bleeding Excluding Intracranial Hemorrhage.

An observational study in Chronic Thrombocytopenia, sponsored by Ain Shams University. Status unknown at 1 site in Egypt. Open to participants aged 4 Years to 18 Years. Per ClinicalTrials.gov, last updated 2013-01-10.

Sponsored by Ain Shams University · Observational

The sponsor has not verified this record recently (last verified Jan 2013), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
100
Ages
4 Years to 18 Years
Sex
All
01

Study summary

Intracranial hemorrhage despite being rare, several chronic ITP patients experience moderate to severe behavioral problems including learning difficulties, memory affection .These changes could be due to the presence of minute capillary dysfunction

Read the detailed description
  • First identify the presence of cognitive, behavioral and/or minimal neurological deficit in patients with chronic ITP and correlate these changes with radiological evidence of minimal CNS bleeding.
  • Second investigate the correlation between these behavioral and/or minimal neurological deficits and duration, site and severity of bleeding (a total of 200 patient of persistently low platelet count \< 20x 10 9 for at least more than one month duration).
  • The aim is to assess the behavioral changes in chronic ITP patients, and to assess the possible relation of such changes to duration and recurrence of very low platelet count as well as pattern of bleeding excluding frank intracranial hemorrhage.
02

Conditions studied

  • Chronic Thrombocytopenia

Keywords

  • Chronic ITP, Cerebral dysfunction
03

In context

Lead sponsor

Ain Shams University is the lead sponsor of 1,932 studies on the registry; 433 are open to participants now.

Of its 33 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Browse Ain Shams University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients will be recruited from those treated in Hematology Clinic, Ain Shams University.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Chronic ITP patients with persistent platelet count \< 20 x 109/L for a period more than one month.
  2. Chronic ITP with more than one attack of wet purpura and OR internal bleeding.

Exclusion criteria

Exclusion Criteria:

  1. Patients' with platelet count persistently more than 40 x 109/L.
  2. Past history of intracranial hemorrhage.
  3. Past history of known neurological or psychological deficit diagnosed before onset of ITP diagnosis
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
100 participants (estimated)
Target follow-up
6 Months
Patient registry
Yes

Groups and cohorts

  • chronic itp and cerebral dysfunction

    patients with chronic itp and had behavioral and or cognitive dysfunction

    Other: IQ assessment and visual- motor assessment · Other: EEG,brain imaging

  • chronic itp only

    chronic ITP patients without cerebral dysfunction

    Other: IQ assessment and visual- motor assessment

Interventions

  • OtherIQ assessment and visual- motor assessment

    Psychological examination and evaluation for both groups to diagnose those with behavioral and /or cognitive dysfunction.

    Also known as: Benton visual retention test (BVRT), Wechsler Intelligence Scale, Wisconsin Card Sorting test

  • OtherEEG,brain imaging

    For patients with cognitive or behavioral deficit, MRI brain and quantitative EEG will be done to identify any CNS abnormality.

    Also known as: quantitative EEG, MRI brain

06

What researchers measure

Primary outcomes

  1. cognitive, behavioral and/or minimal neurological deficit in patients with chronic ITP

    cognitive, behavioral and/or minimal neurological deficit in patients with chronic ITP and correlate these changes with radiological evidence of minimal CNS bleeding.

    Time frame: 6 month

Secondary outcomes

  1. duration, site and severity of bleeding effect of duration, site and severity of bleeding

    behavioral and/or minimal neurological deficits and duration, site and severity of bleeding

    Time frame: 6 months

07

Study locations

1 site
  • hematology clinic, pediatric hospital, Ain Shams University
    Cairo, Egypt
    • Mohsen S Elalfy, professor · Principal investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 10, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01764971
Lead sponsor
Ain Shams University
Responsible party
Mohsen Saleh Elalfy (professor of pediatrics, Ain Shams University) — Principal investigator
First posted
Jan 10, 2013
Start date
Mar 2013
Primary completion
Sep 2013 (estimated)
Completion
Sep 2013 (estimated)
Last update
Jan 10, 2013

Study contacts

yasmine I Elhenawy, lecturer
Contact
dr_yasmi@yahoo.com
0104084038
Mohsen S Elalfy, professor
principal investigator · Ain Shams University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.

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