Coagulopathy of Immunodermatologic Diseases

Coagulopathy of Immunodermatologic Diseases The Molecular, Prognostic, and Therapeutic Implications of Crosstalk Between Coagulation, Fibrinolysis, and Inflammation in Immune-Mediated Skin Diseases

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.

Study Overview

• Status: Recruiting
• Conditions: Autoimmune Bullous Dermatosis
• Intervention / Treatment: Diagnostic test: Blood Draw

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 Type: Observational
• Enrollment (Estimated): 39

Contacts and Locations

• Study Contact: Name: Megan E Wackel, MS; Phone Number: 402-559-3825; Email: megan.wackel@unmc.edu

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • Recruiting
      • University of Nebraska Medical Center
      • Contact: Megan E Wackel, MS; Phone Number: 402-559-3825; Email: megan.wackel@unmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Immune-mediated condition; Participants with an immune-mediated condition	Diagnostic test: Blood Draw; Standard coagulation assays (aPTT, INR, ACT), viscoelastic coagulation profiles (rotational thromboelastometry (ROTEM)/thromboelastography (TEG), tPA-challenged ROTEM/TEG), and molecular profiling
Without immune-mediated dermatologic condition; Participants without an immune-mediated dermatologic condition	Diagnostic test: Blood Draw; Standard coagulation assays (aPTT, INR, ACT), viscoelastic coagulation profiles (rotational thromboelastometry (ROTEM)/thromboelastography (TEG), tPA-challenged ROTEM/TEG), and molecular profiling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Nebraska
• Investigators: Principal Investigator: Erin X Barrett, MD, University of Nebraska

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: August 29, 2023
• First Submitted That Met QC Criteria: September 7, 2023
• First Posted (Actual): September 14, 2023

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Vesiculobullous; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Blood Specimen Collection
• Other Study ID Numbers: 0016-23-EP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No