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

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

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

Study Overview

• Status: Unknown
• Conditions: Chronic Thrombocytopenia
• Intervention / Treatment: Other: IQ assessment and visual- motor assessment; Other: EEG,brain imaging

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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • hematology clinic, pediatric hospital, Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Anticipated): September 1, 2013
• Study Completion (Anticipated): September 1, 2013

Study Registration Dates

• First Submitted: January 8, 2013
• First Submitted That Met QC Criteria: January 8, 2013
• First Posted (Estimate): January 10, 2013

Study Record Updates

• Last Update Posted (Estimate): January 10, 2013
• Last Update Submitted That Met QC Criteria: January 8, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Chronic ITP, Cerebral dysfunction
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hematologic Diseases; Blood Platelet Disorders; Hemorrhage; Intracranial Hemorrhages; Thrombocytopenia
• Other Study ID Numbers: CNS and chronic ITP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No