Management of Childhood Pancytopenia | NCT03521947

Studies
Management of Childhood Pancytopenia

NCT03521947

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

May 11, 2018Actual

Enrollment

25Estimated

Phase

Not provided

Conditions

Pancytopenia

Interventions

Complete blood picture

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2018Estimated

Primary Completion Date

Jun 1, 2019Estimated

Completion Date

Dec 1, 2019Estimated

First Submitted Date

Apr 17, 2018

First Submission Date that Met QC Criteria

May 9, 2018

First Posted Date

May 11, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 9, 2018

Last Update Posted Date

May 11, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Asmaa Otify, Resident doctor of pediatrics, Assiut UniversityPrincipal Investigator

Lead Sponsor

Assiut UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Pancytopenia is an important hematologic Problem.it is a decrease in all three cellular elements of peripheral blood leading to aneamia, leucopenia and thrombocytopenia.

Detailed Description

Pancytopenia usually presents with symptoms of bone marrow failure such as pallor, dysnea, brusing and increased tendency to infections.

The incidence of various disorders causing pancytopenia varies according to Geographical distribution and genetic mutations. It can result from :

Failure of production of hematopoietic progenitors in bone marrow as in aplastic aneamia.
Bone marrow infiltration by malignant cells as in acute leukemia.
Antibodies mediated bone marrow suppression as in systemic lupus.
Ineffective hematopoiesis and dysplasia as in nutrition deficiency.
Peripheral sequestration of blood cells in over active reticuloendothelial system as in hypersplenism.

Pancytopenia is not a disease entity but a triad of findings that may result from primary or secondary bone marrow involvement.

Bone marrow aspiration and biopsy evaluation along with clinical correlation are important to evaluate the causes of pancytopenia and plan further investigations and treatment.

Pancytopenia can result from damage to bone marrow evidanced by low reticulocyte count, or increased destruction of the peripheral blood with increased reticulocyte count.

Bone marrow examination is a simple and safe invasive procedure for evaluating the causes of pancytopenia.

The hypoplastic marrow which occurs in 2% of pediatrics acute lymphoblastic leukemia may be misdiagnosed as aplastic aneamia.

Studies done have shown leukemia to be the second most common cause of pancytopenia in pediatrics, marginally behind aplastic aneamia.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

25Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
One group of children below 18 years old			Diagnostic Test: Complete blood picture

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Complete blood picture	Diagnostic Test	Iaboratory investigation	One group of children below 18 years old

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Availability	Bone marrow examination for all cases [evaluate the causes of pancytopenia and plan further investigations and treatment.]	One year

Secondary Outcomes

Measure	Description	Time Frame
Modification	Guidelines for management of pancytopenia modified or not? [Strategy of blood elements transfusion in treatment]	One year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All childrens and adolescents suffering from pancytopenia attending heamatology unit of pediatric department Assiut University Hospital will be included.

Exclusion Criteria:

childrens and adolescents suffering from pancytopenia due to malignancy.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Weeks

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Childrens and adolescents from age one month up to 18 years old suffering from pancytopenia.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ahmed Gadelrab Askr, Professor	Contact	01114064050		ahmed.mohamed35@med.au.edu.eg

Overall Officials

Not provided

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation
	Background	Hayat,A.S, Khan,A.H,GH and Shaikh, N . (2014). Pancytopenia :study for clinical features and Etiological pattern at a tertiary care settings in Abbottabad.The professional medical journal, 21,060-065.
25992344	Background	Raja S, Suman FR, Scott JX, Latha MS, Rajenderan A, Ethican A. Pancytopenia - (?) An obstacle in the diagnosis and outcome of pediatric acute lymphoblastic leukemia. South Asian J Cancer. 2015 Apr-Jun;4(2):68-71. doi: 10.4103/2278-330X.155648.
25584228

ID	Term
D000095542	Cytopenia
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases