Health TrialsbyHealthPanel

Coagulopathy of Immunodermatologic Diseases

ConditionAutoimmune Bullous Dermatosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorUniversity of Nebraska

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Patients seen at University of Nebraska Medical Center diagnosed with autoimmune bullous disease and patients without a autoimmune bullous disease.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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

Treatment groups

39 Participants
are divided into 2 treatment groups
Group A: Immune-mediated condition1 intervention
Group B: Without immune-mediated dermatologic condition1 intervention

Trial outcomes

Primary outcomes

1

Thromboelastography

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

Time frame
2 years
2

tPA-challenged Thromboelastography

Tests patients blood resistance to tPA-mediated clot lysis.

Time frame
2 years
3

Activated partial thromboplastin time

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.

Time frame
2 years
4

International normalized ratio

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

Time frame
2 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Nebraska

Lead sponsor

Source ClinicalTrials.gov
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