Coagulopathy of Immunodermatologic Diseases

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

39 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-09

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Autoimmune Bullous Dermatosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Immune-mediated condition

Participants with an immune-mediated condition

Blood Draw

Intervention Type DIAGNOSTIC_TEST

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

Without immune-mediated dermatologic condition

Participants without an immune-mediated dermatologic condition

Blood Draw

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Blood Draw

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. 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
2. For control group: no diagnosis of immune-mediated skin
3. For study group: receiving care from one or more of the Principal or Secondary Investigators

Exclusion Criteria

1. Unfit to provide consent
2. P2Y12 inhibitor use in the past 4 weeks
3. 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)
4. Major surgery within 4 weeks of the study or trauma (e.g., accident-causing bone fracture) within 4 weeks of the study
5. Other autoimmune diseases not in remission defined as flare in the last 12 weeks
6. If patient is unable to provide detailed history and if we do not have sufficient history on record.
7. Less than 19 years of age

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes