Coagulopathy of Immunodermatologic Diseases The Molecular, Prognostic, and Therapeutic Implications of Crosstalk Between Coagulation, Fibrinolysis, and Inflammation in Immune-Mediated Skin Diseases
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Nebraska
- Enrollment
- 39
- Locations
- 1
- Primary Endpoint
- tPA-challenged Thromboelastography
Study Overview
Brief 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.
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Without immune-mediated dermatologic condition
Participants without an immune-mediated dermatologic condition
Intervention: Blood Draw (Diagnostic Test)
Immune-mediated condition
Participants with an immune-mediated condition
Intervention: Blood Draw (Diagnostic Test)
Outcomes
Primary Outcomes
tPA-challenged Thromboelastography
Time Frame: 2 years
Tests patients blood resistance to tPA-mediated clot lysis.
International normalized ratio
Time Frame: 2 years
International Normalized Ratio is a measure of how long it takes your blood to clot.
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.
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.
Secondary Outcomes
No secondary outcomes reported