Actively Recruiting
Coagulopathy of Immunodermatologic Diseases The Molecular, Prognostic, and Therapeutic Implications of Crosstalk Between Coagulation, Fibrinolysis, and Inflammation in Immune-Mediated Skin Diseases
Led by University of Nebraska · Updated on 2026-05-12
39
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the coagulation and fibrinolysis profiles in people with autoimmune skin diseases, such as bullous pemphigoid, pemphigus vulgaris, mucous membrane pemphigoid, cutaneous lupus erythematosus, and dermatomyositis. The study compares blood samples from participants with active or poorly controlled immune-mediated skin diseases and those with mild or well-controlled conditions. A control group of general dermatology outpatients without immune-mediated skin diseases or certain skin cancers will also provide samples. This observational study aims to help guide future research on how these blood profiles relate to autoimmune skin conditions. Participants will have a one-time blood draw to measure various coagulation and inflammatory markers. Tests include standard coagulation assays such as activated partial thromboplastin time (aPTT) and international normalized ratio (INR), as well as viscoelastic coagulation profiles like rotational thromboelastometry and thromboelastography, including tPA-challenged versions. Blood samples from both groups will be analyzed and compared to understand differences in coagulation and fibrinolysis related to immune-mediated skin diseases. During the study, participants will provide detailed medical history and have their blood collected once for analysis. Researchers will measure primary outcomes including thromboelastography, tPA-challenged thromboelastography, aPTT, and INR over a two-year period to track coagulation function. This study includes adult participants aged 19 and older and involves healthy volunteers as controls. The total participation involves one visit for blood sample collection and history review.
CONDITIONS
Brief Title
Coagulopathy of Immunodermatologic Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 19 years or older
- Diagnosis of immune-mediated skin disease such as bullous pemphigoid, pemphigus vulgaris, mucous membrane pemphigoid, cutaneous lupus erythematosus, or dermatomyositis (for study group)
- No diagnosis of immune-mediated skin disease (for control group)
- Receiving care from one or more of the Principal or Secondary Investigators (for study group)
You will not qualify if you...
- Unable to provide consent
- Use of P2Y12 inhibitors in the past 4 weeks
- History of internal malignancy or suspected internal/systemic malignancy at time of study
- Major surgery or trauma within 4 weeks prior to study
- Other autoimmune diseases not in remission with flare in last 12 weeks
- Unable to provide detailed medical history or insufficient history on record
- Younger than 19 years of age
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants have blood samples collected once to analyze coagulation and inflammatory markers.
1 visit (in-person)
Duration - 2 years
Participants are monitored for outcomes related to coagulation profiles over 2 years.
Visits as needed for outcome assessments
Trial Site Locations
Total: 1 location
1
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
Research Team
M
Megan E Wackel, MS
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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