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Evaluation of Bleeding Score in Egyptian Patients With vWD Type I and Correlate it With Laboratory Parameters

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ClinicalTrials.gov Identifier: NCT03915873
Recruitment Status : Not yet recruiting
First Posted : April 16, 2019
Last Update Posted : September 10, 2019
Sponsor:
Information provided by (Responsible Party):
shery nabil Hennes abdl-sayed, Assiut University

Brief Summary:
Applying the ISTH-BAT questionnaire on Egyptian patients with type I VWD aiming to correlate the BS with the laboratory findings

Condition or disease Intervention/treatment
Von Willebrand Disease, Type 1 Diagnostic Test: The von Willebrand Antigen level

Detailed Description:
The clinical phenotype of the disease is variable and tends to be mild in type 1 vWD, whereas it shows serious bleeding manifestations in types 2 and 3. Overall, the symptoms reported in vWD include easy bruising, epistaxis, gastrointestinal bleeding, excessive menstrual bleeding, postpartum haemorrhage, and excessive bleeding after surgical operation and minor wounds.However, A distinctive bleeding history is a prerequisite for the diagnosis of any bleeding disorder and should guide further laboratory investigations In an attempt to standardize the diagnostic criteria of VWD, a bleeding questionnaire and a bleeding score were developed The combination of a standardized bleeding questionnaire and a well-defined interpretation grid (for the computation of the final (BS) has been referred to as a Bleeding Assessment Tool (BAT).

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Assessing the Bleeding Severity in Type I Von Willebrand Patients Using the International Society on Thrombosis and Hemostasis Bleeding Assessment Tool ( ISTH-BAT) Questionnaire
Estimated Study Start Date : December 1, 2019
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Group/Cohort Intervention/treatment
vWB patients Diagnostic Test: The von Willebrand Antigen level
blood sample

control



Primary Outcome Measures :
  1. the International Society on Thrombosis and Hemostasis-Bleeding Assessment Tool (ISTH-BAT) [ Time Frame: one year ]
    Questionnaire minimum score ranges from 0 to 10 whereas maximum score ranges from 20 to 30



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
type 1 von willebrand egyptian patients
Criteria

Inclusion Criteria:

  • type 1 vWD patients
  • healthy subjects with no known problem with bleeding or bruising were also recruited

Exclusion Criteria:

-

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Responsible Party: shery nabil Hennes abdl-sayed, principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03915873    
Other Study ID Numbers: BS in VWD
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: September 2019

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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 shery nabil Hennes abdl-sayed, Assiut University:
von willebrand
egyptian
questionnaire
Additional relevant MeSH terms:
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Von Willebrand Diseases
Von Willebrand Disease, Type 1
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Blood Platelet Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn