Coagulopathy of Immunodermatologic Diseases

Conditions

• Autoimmune Bullous Dermatosis

Eligibility Criteria

Sex

ALL

Age

19 Years - N/A

Healthy Volunteers

Accepted

Interventions

• 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

Study Details

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.

Key Dates

Start date

May 9, 2023

Status verified

Aug 2025

Primary completion

Aug 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

39 participants (estimated)

Arms

• Arm: Immune-mediated condition
  Participants with an immune-mediated condition
• Arm: Without immune-mediated dermatologic condition
  Participants without an immune-mediated dermatologic condition

Primary Outcome Measure

Thromboelastography [ Time Frame: 2 years ]

Central Contacts

• Megan E Wackel, MS
  402-559-3825
  [email protected]

Locations (1)

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