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Cross-sectional Study on Prevalence of Coagulation Factors Deficiency in Assiut University Children Hospital (coagdef)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03273998
Recruitment Status : Unknown
Verified September 2017 by YHAlattar, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : September 6, 2017
Last Update Posted : September 12, 2017
Sponsor:
Information provided by (Responsible Party):
YHAlattar, Assiut University

Brief Summary:
Blood coagulation is a complex mechanism that is required for the rapid establishment of a stable fibrin clot. A series of interdependent enzyme-mediated reactions translate the molecular signals that initiate blood coagulation into the formation of the fibrin clot. Congenital coagulopathies result when there is a deficiency of protein co factors and enzymes implicated in blood coagulation

Condition or disease
Coagulation Factor Deficiency

Show Show detailed description

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Cross-sectional Study on Prevalence of Coagulation Factors Deficiency in Children Attending Assiut University Children Hospital ( a One Year Study)
Estimated Study Start Date : April 1, 2018
Estimated Primary Completion Date : April 1, 2019
Estimated Study Completion Date : April 1, 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. prevalence of children with coagulation factors deficiency in Assiut University Children Hospital measured by coagulation factor deficiency checklist [ Time Frame: 1year ]
    data collected in sheet measuring type and level of deficient factor and measuring clotting tests(e.g. pt ,aptt)


Secondary Outcome Measures :
  1. evaluation of inheritance of coagulation fa tors deficiency through the checklist measuring other affected family members [ Time Frame: 1year ]
    number of family members having coag factors deficiency , their age ,sex

  2. evaluation of infectious disease by measuring hepatitis c virus and human immunodeficiency virus [ Time Frame: one year ]
    hepatitis c virus and human immunodeficiency virus testing



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
children with coagulation factors deficiency in Assiut University Children Hospital
Criteria

Inclusion Criteria:

  • All patients with congenital bleeding disorders secondary to coagulation factor deficiency and attending in Assiut University Children Hospital will be included in the study

Exclusion Criteria:

  • Patients with:

Acquired bleeding disorders Thrombasthenia thrombocytopenia


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03273998


Contacts
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Contact: Khalid Ibrahim El-Sayeh, Professor 01005484357 elsayh23@yahoo.com
Contact: Mohamed Amir Othman, Ass prof 01005689353 m_amir_riad@aun.edu.eg

Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: yomna alattar, resident Assiut University

Publications of Results:
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Responsible Party: YHAlattar, principle investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03273998    
Other Study ID Numbers: Coag Def
First Posted: September 6, 2017    Key Record Dates
Last Update Posted: September 12, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by YHAlattar, Assiut University:
coagulation
bleeding