Coagulopathy of Immunodermatologic Diseases

NCT06037187 | Recruiting

• 1 other identifier: 0016-23-EP
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Autoimmune Bullous Dermatosis

Outcome Measures

Primary Outcomes (4)

• Thromboelastography

  Thromboelastography is a viscoelastic hemostatic assay that measures the global viscoelastic properties of whole blood clot formation under low shear stress.

  2 years

• tPA-challenged Thromboelastography

  Tests patients blood resistance to tPA-mediated clot lysis.

  2 years

• Activated partial thromboplastin time

  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.

  2 years

• International normalized ratio

  International Normalized Ratio is a measure of how long it takes your blood to clot.

  2 years

Study Arms (2)

Immune-mediated condition

Participants with an immune-mediated condition

Diagnostic Test: Blood Draw

Without immune-mediated dermatologic condition

Participants without an immune-mediated dermatologic condition

Diagnostic Test: Blood Draw

Interventions

Blood Draw DIAGNOSTIC_TEST

Standard coagulation assays (aPTT, INR, ACT), viscoelastic coagulation profiles (rotational thromboelastometry (ROTEM)/thromboelastography (TEG), tPA-challenged ROTEM/TEG), and molecular profiling

Immune-mediated condition; Without immune-mediated dermatologic condition

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients seen at University of Nebraska Medical Center diagnosed with autoimmune bullous disease and patients without a autoimmune bullous disease.

You may qualify if:

• 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
• For control group: no diagnosis of immune-mediated skin
• For study group: receiving care from one or more of the Principal or Secondary Investigators

You may not qualify if:

• Unfit to provide consent
• P2Y12 inhibitor use in the past 4 weeks
• 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)
• Major surgery within 4 weeks of the study or trauma (e.g., accident-causing bone fracture) within 4 weeks of the study
• Other autoimmune diseases not in remission defined as flare in the last 12 weeks
• If patient is unable to provide detailed history and if we do not have sufficient history on record.
• Less than 19 years of age

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

RECRUITING

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Erin X Barrett, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Megan E Wackel, MS

CONTACT

402-559-3825; megan.wackel@unmc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: September 14, 2023
• Study Start: May 9, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 12, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)