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

• Conditions: Chronic Thrombocytopenia
• Interventions: Other: IQ assessment and visual- motor assessment; Other: EEG,brain imaging

• Registration Number: NCT01764971
• Lead Sponsor: Ain Shams University

Brief 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

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 Timeline

• Status Verified: 2013-01
• Study First Submitted: 2013-01-08
• Study First Submitted QC: 2013-01-08
• Last Update Submitted: 2013-01-08
• Study First Posted: 2013-01-10
• Last Update Posted: 2013-01-10
• Study Start: 2013-03
• Primary Completion: 2013-09
• Study Completion: 2013-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
chronic itp and cerebral dysfunction	IQ assessment and visual- motor assessment	patients with chronic itp and had behavioral and or cognitive dysfunction
chronic itp and cerebral dysfunction	EEG,brain imaging	patients with chronic itp and had behavioral and or cognitive dysfunction
chronic itp only	IQ assessment and visual- motor assessment	chronic ITP patients without cerebral dysfunction

Primary Outcome Measures

Name	Time	Method
cognitive, behavioral and/or minimal neurological deficit in patients with chronic ITP	6 month	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

Name	Time	Method
duration, site and severity of bleeding effect of duration, site and severity of bleeding	6 months	behavioral and/or minimal neurological deficits and duration, site and severity of bleeding

Trial Locations

Locations (1)

hematology clinic, pediatric hospital, Ain Shams University; 🇪🇬 Cairo, Egypt