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

Chronic Thrombocytopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01764971
• Other study ID #: CNS and chronic ITP
• Status: Not yet recruiting
• Phase: N/A
• First received: January 8, 2013
• Last updated: January 8, 2013
• Start date: March 2013
• Est. completion date: September 2013

Study information

• Verified date: January 2013
• Source: Ain Shams University
• Contact: yasmine I Elhenawy, lecturer
• Phone: 0104084038
• Email: dr_yasmi[@]yahoo.com
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 18 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Thrombocytopenia
• Intracranial Hemorrhages
• Thrombocytopenia
• Thrombocytosis

Intervention

Other:
• IQ assessment and visual- motor assessment
Psychological examination and evaluation for both groups to diagnose those with behavioral and /or cognitive dysfunction.
• EEG,brain imaging
For patients with cognitive or behavioral deficit, MRI brain and quantitative EEG will be done to identify any CNS abnormality.

Locations

Country	Name	City	State
Egypt	hematology clinic, pediatric hospital, Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes