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

September 7, 2019 updated by: shery nabil Hennes abdl-sayed, Assiut University

Assessing the Bleeding Severity in Type I Von Willebrand Patients Using the International Society on Thrombosis and Hemostasis Bleeding Assessment Tool ( ISTH-BAT) Questionnaire

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

Study Overview

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).

Study Type

Observational

Enrollment (Anticipated)

20

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

type 1 von willebrand egyptian patients

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
control
vWB patients
blood sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

December 1, 2019

Primary Completion (ANTICIPATED)

December 1, 2020

Study Completion (ANTICIPATED)

March 1, 2021

Study Registration Dates

First Submitted

April 12, 2019

First Submitted That Met QC Criteria

April 15, 2019

First Posted (ACTUAL)

April 16, 2019

Study Record Updates

Last Update Posted (ACTUAL)

September 10, 2019

Last Update Submitted That Met QC Criteria

September 7, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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