Chronic ThrombocytopeniaNCT01764971
Cerebral Dysfunction in Chronic ITPwith High Risk of Serious Bleeding Excluding Intracranial Hemorrhage.
An observational study of Chronic Thrombocytopenia, run by Ain Shams University at 1 site in Egypt.
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 Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Chronic Thrombocytopenia
- What is being tested?
- IQ assessment and visual- motor assessment and EEG,brain imaging
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2013to Sep 2013
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients will be recruited from those treated in Hematology Clinic, Ain Shams University.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site
hematology clinic, pediatric hospital, Ain Shams University
Cairo
Mohsen S Elalfy, professor
About this study
Official title: 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
Read the 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.
- Conditions
- Chronic Thrombocytopenia
- Being tested
- IQ assessment and visual- motor assessment, EEG,brain imaging
- Keywords
- Chronic ITP, Cerebral dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IQ assessment and visual- motor assessmentOther
Also called Benton visual retention test (BVRT), Wechsler Intelligence Scale, Wisconsin Card Sorting test
Psychological examination and evaluation for both groups to diagnose those with behavioral and /or cognitive dysfunction.
EEG,brain imagingOther
Also called quantitative EEG, MRI brain
For patients with cognitive or behavioral deficit, MRI brain and quantitative EEG will be done to identify any CNS abnormality.
| Study group | Role | What they receive |
|---|---|---|
| chronic itp and cerebral dysfunction | patients with chronic itp and had behavioral and or cognitive dysfunction Receives: Other: IQ assessment and visual- motor assessment; Other: EEG,brain imaging | |
| chronic itp only | chronic ITP patients without cerebral dysfunction Receives: Other: IQ assessment and visual- motor assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 month
Secondary outcomes (1)
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2013 (estimated)
- Study startMar 2013
- Primary completionSep 2013 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic ThrombocytopeniaStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohsen Saleh Elalfy, Ain Shams University
- Investigators
- Mohsen S Elalfy, professor, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01764971
- Sponsor's protocol ID
- CNS and chronic ITP
- Status last verified
- Jan 2013
- First submitted
- 8 Jan 2013
- Last updated
- 10 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Dysfunction in Chronic ITP With High Risk of Serious Bleeding Excluding Intracranial Hemorrhage.
- ClinicalTrials.gov ID
- NCT01764971
- Acronym / sponsor ID
- CNS and chronic ITP
- Conditions
- Chronic Thrombocytopenia
- Keywords
- Chronic ITP, Cerebral dysfunction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 10 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| chronic itp and cerebral dysfunction | – | Other: IQ assessment and visual- motor assessment, Other: EEG,brain imagingpatients with chronic itp and had behavioral and or cognitive dysfunction |
| chronic itp only | – | Other: IQ assessment and visual- motor assessmentchronic ITP patients without cerebral dysfunction |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients will be recruited from those treated in Hematology Clinic, Ain Shams University.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IQ assessment and visual- motor assessmentAlso: Benton visual retention test (BVRT), Wechsler Intelligence Scale, Wisconsin Card Sorting testPsychological examination and evaluation for both groups to diagnose those with behavioral and /or cognitive dysfunction. | Other | chronic itp and cerebral dysfunction, chronic itp only |
| EEG,brain imagingAlso: quantitative EEG, MRI brainFor patients with cognitive or behavioral deficit, MRI brain and quantitative EEG will be done to identify any CNS abnormality. | Other | chronic itp and cerebral dysfunction |
Primary outcome
cognitive, behavioral and/or minimal neurological deficit in patients with chronic ITP
Time frame: 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.
1 secondary outcome
duration, site and severity of bleeding effect of duration, site and severity of bleeding
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2013.
Related trials for Chronic Thrombocytopenia
RecruitingPhase 3
A Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia
Immune Thrombocytopenic Purpura (ITP)
RecruitingPhase 3
Phase 3 Study of rhTPO for Thrombocytopenia in Chronic Liver Disease Patients Undergoing Elective Invasive Procedures.
Thrombocytopenia Associated With Chronic Liver Disease
RecruitingPhase 3
A Follow-up Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia
Immune Thrombocytopenic Purpura (ITP)
RecruitingObservational study
Collection of Human Samples to Study Hairy Cell and Other Leukemias, and to Develop Recombinant Immunotoxins for Cancer Treatment
Hairy Cell Leukemia (HCL), Chronic Lymphocytic Leukemia (CLL)
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohsen S Elalfy, professor principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Thrombocytopenia, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact yasmine I Elhenawy, lecturer (0104084038, dr_yasmi@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cognitive, behavioral and/or minimal neurological deficit in patients with chronic ITP (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2013.