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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03915873
Recruitment Status : Not yet recruiting
First Posted : April 16, 2019
Last Update Posted : September 10, 2019
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


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

Information from the National Library of Medicine

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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

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 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
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