Characterization of Bleeding Disorders in EDS | NCT05434728

Studies
Characterization of Bleeding Disorders in EDS

NCT05434728

Sponsor

University Health Network, Toronto

Status

Unknown status

Last Update Posted

May 9, 2023Actual

Enrollment

45Estimated

Phase

Not provided

Conditions

Ehlers-Danlos Syndrome
EDS
Classical Ehlers-Danlos Syndrome
Classical EDS (cEDS)
Hypermobile Ehlers-Danlos Syndrome
Hypermobile EDS (hEDS)
Vascular Ehlers-Danlos Syndrome
Vascular EDS (vEDS)

Interventions

20 ml venous blood collection

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2022Actual

Primary Completion Date

Dec 1, 2023Estimated

Completion Date

Feb 1, 2024Estimated

First Submitted Date

Jun 17, 2022

First Submission Date that Met QC Criteria

Jun 22, 2022

First Posted Date

Jun 28, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 8, 2023

Last Update Posted Date

May 9, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nimish Mittal, Medical Director - GoodHope EDS Clinic, Toronto General Hospital, University Health Network, TorontoPrincipal Investigator

Lead Sponsor

University Health Network, TorontoOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Ehlers-Danlos Syndrome (EDS) is a disease that weakens the connective tissues (i.e. tendons and ligaments) in the human body. EDS can make the joints loose and alter skin and wound healing. It can also weaken blood vessels and organs. Many EDS patients are referred for investigation of bleeding symptoms. Although most patients will have mild symptoms such as bruising, many will experience significant bleeding that can be life-threatening. The physiological reason behind this has not been identified and therefore, treating this is challenging. In addition, patients with EDS frequently require major surgery due to complications from their connective tissue disease. These surgery carries a significant risk of catastrophic bleeding which is further magnified in this group of patients. The specific reason of clinical bleeding in patients with EDS is likely multifactorial, including skin and blood vessel fragility leading to increased bruising and poor wound healing, coagulopathies related to factor deficiency, acquired vonWillebrand disease (VWD), and notable platelet dysfunction.

Despite compelling preliminary evidence, there is limited data on the diagnosis and management of platelet dysfunction in EDS patients. Therefore, in this study we will characterize hemostasis, the medical term which refers to the process of stopping blood flow, across the three most common subtypes of EDS.we will also determine the burden of illness of pathologic bleeding in patients with Ehlers-Danlos Syndrome (EDS) using validated patient reported tools.

Detailed Description

Not provided

Conditions Module

Conditions

Ehlers-Danlos Syndrome
EDS
Classical Ehlers-Danlos Syndrome
Classical EDS (cEDS)
Hypermobile Ehlers-Danlos Syndrome
Hypermobile EDS (hEDS)
Vascular Ehlers-Danlos Syndrome
Vascular EDS (vEDS)

Keywords

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

45Estimated

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
Hypermobile EDS	Individuals with a confirmed diagnosis of hypermobile EDS	Other: 20 ml venous blood collection
Classical EDS	Individuals with a confirmed diagnosis of classical EDS	Other: 20 ml venous blood collection
Vascular EDS	Individuals with a confirmed diagnosis of vascular EDS	Other: 20 ml venous blood collection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
20 ml venous blood collection	Other	participant blood sample will be divided between sample EDTA sample tubes for thrombin generation testing and viscoelastic (ROTEM) testing of impaired hemostasis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The prevalence of platelet dysfunction among patients with a known diagnosis of EDS		6 months

Secondary Outcomes

Measure	Description	Time Frame
The severity of platelet dysfunction (as characterized by the percentage of non-functional platelets) in patients with EDS		6 months
The prevalence and severity of impaired thrombin generation as assessed through thrombin generation testing in patients with EDS

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Any adult (≥ 18 years) patient with a known diagnosis of Ehlers Danlos Syndrome (Subtypes Classical, Hypermobile, or Vascular) as per the 2017 International Classification of Ehlers Danlos Syndrome.

Exclusion Criteria:

Subtypes of Ehlers Danlos Syndrome which are not Classical, Hypermobile, or Vascular.
Unable or unwilling to consent for the study

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Any adult (≥ 18 years) patient with a known diagnosis of Ehlers Danlos Syndrome (Subtypes Classical, Hypermobile, or Vascular) as per the 2017 International Classification of Ehlers Danlos Syndrome.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nimish Mittal, MBBS, MD	University Health Network - University of Toronto	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
GoodHope EDS - Toronto General Hospital		Toronto	Ontario	M5G 2C4	Canada

Condition Browse Module

MeSH Terms

ID	Term
D004535	Ehlers-Danlos Syndrome
C536194	Ehlers-Danlos syndrome type 1
C536196	Ehlers-Danlos syndrome type 3
D000094623	Ehlers-Danlos Syndrome, Type IV

Ancestor Terms

ID	Term
D020141	Hemostatic Disorders
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D006474	Hemorrhagic Disorders

Browse Leaves

Not provided

Browse Branches

Not provided