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

This study is not yet open for participant recruitment.
Verified January 2013 by Ain Shams University
Sponsor:
Information provided by (Responsible Party):
Mohsen Saleh Elalfy, Ain Shams University
ClinicalTrials.gov Identifier:
NCT01764971
First received: January 8, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose

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


Condition Intervention
Chronic Thrombocytopenia
 Other: IQ assessment and visual- motor assessment
Other: EEG,brain imaging

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Cerebral Dysfunction in Chronic ITP With High Risk of Serious Bleeding Excluding Intracranial Hemorrhage.

Further study details as provided by Ain Shams University:

Primary Outcome Measures:
  • cognitive, behavioral and/or minimal neurological deficit in patients with chronic ITP [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
    cognitive, behavioral and/or minimal neurological deficit in patients with chronic ITP and correlate these changes with radiological evidence of minimal CNS bleeding.


Secondary Outcome Measures:
  • duration, site and severity of bleeding effect of duration, site and severity of bleeding [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    behavioral and/or minimal neurological deficits and duration, site and severity of bleeding


Estimated Enrollment: 100
Study Start Date: March 2013
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
chronic itp and cerebral dysfunction
patients with chronic itp and had behavioral and or cognitive dysfunction
 Other: IQ assessment and visual- motor assessment
Psychological examination and evaluation for both groups to diagnose those with behavioral and /or cognitive dysfunction.
Other Names:
  • Benton visual retention test (BVRT)
  • Wechsler Intelligence Scale
  • Wisconsin Card Sorting test
Other: EEG,brain imaging
For patients with cognitive or behavioral deficit, MRI brain and quantitative EEG will be done to identify any CNS abnormality.
Other Names:
  • quantitative EEG
  • MRI brain
chronic itp only
chronic ITP patients without cerebral dysfunction
 Other: IQ assessment and visual- motor assessment
Psychological examination and evaluation for both groups to diagnose those with behavioral and /or cognitive dysfunction.
Other Names:
  • Benton visual retention test (BVRT)
  • Wechsler Intelligence Scale
  • Wisconsin Card Sorting test

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.
  Eligibility

Ages Eligible for Study:   4 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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:

  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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01764971

Contacts
Contact: yasmine I Elhenawy, lecturer 0104084038 dr_yasmi@yahoo.com

Locations
Egypt
hematology clinic, pediatric hospital, Ain Shams University Not yet recruiting
Cairo, Egypt
Principal Investigator: Mohsen S Elalfy, professor            
Sponsors and Collaborators
Ain Shams University
Investigators
Principal Investigator: Mohsen S Elalfy, professor Ain Shams University
  More Information

No publications provided

Responsible Party: Mohsen Saleh Elalfy, professor of pediatrics, Ain Shams University
ClinicalTrials.gov Identifier: NCT01764971     History of Changes
Other Study ID Numbers: CNS and chronic ITP
Study First Received: January 8, 2013
Last Updated: January 8, 2013
Health Authority: Egypt: Institutional Review Board

Keywords provided by Ain Shams University:
Chronic ITP, Cerebral dysfunction

Additional relevant MeSH terms:
Hemorrhage
Thrombocytopenia
Intracranial Hemorrhages
Pathologic Processes
Blood Platelet Disorders
Hematologic Diseases
 Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 21, 2013