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NCT Number: NCT06037187

Coagulopathy of Immunodermatologic 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.

Recruiting

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location status: Recruiting

Location contact

Megan E Wackel, MS

CONTACT

[email protected]

402-559-3825

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

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

Primary outcomes

  1. Thromboelastography

    Time frame: 2 years

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

  2. tPA-challenged Thromboelastography

    Time frame: 2 years

    Tests patients blood resistance to tPA-mediated clot lysis.

  3. Activated partial thromboplastin time

    Time frame: 2 years

    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.

  4. International normalized ratio

    Time frame: 2 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Megan E Wackel, MS

CONTACT

[email protected]

402-559-3825

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 14, 2023
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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