Ignite Creation Date:
2024-05-06 @ 4:02 PM
Last Modification Date:
2024-10-26 @ 2:02 PM
Study NCT ID:
NCT04849338
Status:
UNKNOWN
Last Update Posted:
2021-04-19
First Post:
2021-04-14
Brief Title:
The Role of Standardized Bleeding Score in Diagnosis of Pediatric Von Willebrands Disease
Sponsor:
Sohag University
Organization:
Sohag University
Study Overview
Official Title:
The Role of Standardized Bleeding Score in Diagnosis of Pediatric Von Willebrands Disease
Status:
UNKNOWN
Status Verified Date:
2021-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Von Willebrands disease VWD is the most common inherited bleeding disorder It arises from a deficiency in the quality or quantity of von Willebrand factor VWF a multimeric protein that is required for platelet adhesion Typical patients present with mucocutaneous bleeding symptoms because of reduced circulating von Willebrand factor VWF In this study we will use the ISTHSSC BLEEDING assessment tool as a standardized questionnaire and a proposal for a new bleeding score for inherited bleeding disorders
Detailed Description:
Von Willebrands disease VWD is the most common inherited bleeding disorder It arises from a deficiency in the quality or quantity of von Willebrand factor VWF a multimeric protein that is required for platelet adhesion Typical patients present with mucocutaneous bleeding symptoms because of reduced circulating von Willebrand factor VWF A predictive bleeding score could reveal individuals who may benefit from repetitive testing and those for whom repetitive testing is unlikely to be of benefit In 2005 Rodeghiero et al developed a standardized questionnaire for the evaluation of haemorrhagic symptoms referred to hereafter as the Vicenza score Their retrospective analysis found that 3 haemorrhagic symptoms or bleeding scores of 3 in men and 5 in women was very specific 986 for VWD although less sensitive 691 These investigators later reported in a larger population that higher bleeding scores were associated with increasing likelihood of VWD and bleeding after surgery or tooth extraction Neither of these studies prospectively surveyed paediatric populations As a result of their shorter life experience children have fewer exposures to bleeding challenges such as dental extractions surgeries menarche and childbirth In 2009 Bowman et al administered a modified Vicenza bleeding score to a naive primary care paediatric population and determined a bleeding score 2 was abnormal Using this definition their bleeding score had a high negative predictive value 099 and could accurately distinguish between children with and without VWD In this study we will use the ISTHSSC BLEEDING assessment tool as a standardized questionnaire and a proposal for a new bleeding score for inherited bleeding disorders For each specific bleeding symptom the ISTHSSC joint working group proposed minimal criteria in order to classify a symptom as significant and thus receive a score of 1 or more Symptoms included in this questionnaire are epistaxis cutaneous bleeding minor cutaneous wound oral cavity bleeding hematemesis melena and hematochezia hematuria tooth extraction surgical bleeding menorrhagia postpartum bleeding muscle hematomas or hemoarthrosis and CNS bleeding
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None