RecruitingNCT06037187

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


Sponsor

University of Nebraska

Enrollment

39 participants

Start Date

May 9, 2023

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 19 Years

Inclusion Criteria3

  • 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

Exclusion Criteria7

  • 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

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Interventions

DIAGNOSTIC_TESTBlood Draw

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


Locations(1)

University of Nebraska Medical Center

Omaha, Nebraska, United States

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NCT06037187


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