Actively Recruiting

Age: 19Years +
All Genders
Healthy Volunteers
ID06037187

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

Age: 19Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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)
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 day

Participants have blood samples collected once to analyze coagulation and inflammatory markers.

1 visit (in-person)

Long-term Monitoring

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

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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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