Coagulopathy of Immunodermatologic Diseases

Recruiting

• Conditions: Autoimmune Bullous Dermatosis
• Interventions: Diagnostic Test: Blood Draw

• Registration Number: NCT06037187
• Lead Sponsor: University of Nebraska

Brief Summary

This study will examine the coagulation and fibrinolysis profiles of those with autoimmune skin diseases. Blood samples will be collected from participants with active/poorly controlled immune-mediated skin diseases and mild/latent/well-controlled immune-mediated skin diseases. A one-time sample from 15 general dermatology outpatients who do not have a known or suspected diagnosis of bullous diseases, immune-mediated dermatologic condition, or cutaneous malignancy will also be collected to serve as control. Blood samples from both participant populations will be analyzed for coagulation and inflammatory markers and compared. The results of this study may help inform future studies on the utility of analyzing coagulation and fibrinolysis profiles of patients with autoimmune skin diseases.

Detailed Description

The purpose of this study is to examine the coagulation and fibrinolysis profiles of those with autoimmune skin diseases. This will be accomplished by collecting blood samples from participants with both active/poorly controlled immune-mediated skin diseases and mild/latent/well-controlled immune-mediated skin diseases. A one-time sample will be collected from 15 general dermatology outpatients who do not have a known or suspected diagnosis of bullous diseases, immune-mediated dermatologic condition, or cutaneous malignancy to serve as the control population. Blood samples from both participant populations will be analyzed for coagulation and inflammatory markers and compared. The results of this study may help inform future studies on the utility of analyzing coagulation and fibrinolysis profiles of patients with autoimmune skin diseases.

Study Timeline

• Study Start: 2023-05-09
• Study First Submitted: 2023-08-29
• Study First Submitted QC: 2023-09-07
• Study First Posted: 2023-09-14
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-15
• Primary Completion: 2025-08
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

1. For the study group: diagnosis of immune-mediated skin disease including but not limited to bullous pemphigoid, pemphigus vulgaris, mucous membrane pemphigoid, cutaneous lupus erythematosus, dermatomyositis
2. For control group: no diagnosis of immune-mediated skin
3. For study group: receiving care from one or more of the Principal or Secondary Investigators

Exclusion Criteria

1. Unfit to provide consent
2. P2Y12 inhibitor use in the past 4 weeks
3. History of internal malignancy prior to enrolling in the study or suspected internal/systemic malignancy during time of the study (i.e. will not exclude pre-malignant or local, early stage cutaneous malignancies)
4. Major surgery within 4 weeks of the study or trauma (e.g., accident-causing bone fracture) within 4 weeks of the study
5. Other autoimmune diseases not in remission defined as flare in the last 12 weeks
6. If patient is unable to provide detailed history and if we do not have sufficient history on record.
7. Less than 19 years of age

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Without immune-mediated dermatologic condition	Blood Draw	Participants without an immune-mediated dermatologic condition
Immune-mediated condition	Blood Draw	Participants with an immune-mediated condition

Primary Outcome Measures

Name	Time	Method
tPA-challenged Thromboelastography	2 years	Tests patients blood resistance to tPA-mediated clot lysis.
International normalized ratio	2 years	International Normalized Ratio is a measure of how long it takes your blood to clot.
Thromboelastography	2 years	Thromboelastography is a viscoelastic hemostatic assay that measures the global viscoelastic properties of whole blood clot formation under low shear stress.
Activated partial thromboplastin time	2 years	Activated partial thromboplastin time measures the length of time (in seconds) that it takes for clotting to occur when specific reagents are added to plasma.

Trial Locations

Locations (1)

University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States