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

NCT01764971 | Unknown DMC

• 1 other identifier: CNS and chronic ITP
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Thrombocytopenia

Keywords

Chronic ITP, Cerebral dysfunction

Outcome Measures

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.

  6 month

Secondary Outcomes (1)

• duration, site and severity of bleeding effect of duration, site and severity of bleeding

  6 months

Study Arms (2)

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

IQ assessment and visual- motor assessment OTHER

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

chronic itp and cerebral dysfunction; chronic itp only

EEG,brain imaging OTHER

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

chronic itp and cerebral dysfunction

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

hematology clinic, pediatric hospital, Ain Shams University

Cairo, Egypt

Location

MeSH Terms

Interventions

Wechsler Scales; Wisconsin Card Sorting Test

Intervention Hierarchy (Ancestors)

Intelligence Tests; Aptitude Tests; Psychological Tests; Behavioral Disciplines and Activities; Neuropsychological Tests

Study Officials

• Mohsen S Elalfy, professor

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

yasmine I Elhenawy, lecturer

CONTACT

0104084038; dr_yasmi@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor of pediatrics

Study Record Dates

• First Submitted: January 8, 2013
• First Posted: January 10, 2013
• Study Start: March 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: January 10, 2013

Record last verified: 2013-01

Locations

EG (1)