Effects of Therapeutic Plasmaexhange on Viscoelastic Tests in Non-coagulopathic Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04513249

Enrollment

Registered

2020-08-14

Start date

2017-05-10

Completion date

2017-12-30

Last updated

2020-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transfusion Related Complication

Brief summary

Therapeutic plasma exchange is widely performed in patients with autoimmune disease. The exact effects of fresh frozen plasma on coagulation in this group of patients remains unknown. In order to investigate this issue the present study monitors periprocedural coagulation status with the aid of standard coagulation tests and rotational thromboelastometry. Four thromboelastometric tests will be performed: ExTEM, InTEM, FibTEM and ApTEM. The following parameters will be recorded from each test: CT (sec), CFT (sec) and MCF (mm) one hour before and one hour after plasmaechange was performed.

Interventions

DIAGNOSTIC_TESTdynamics of coagulation parameters

the effects of fresh frozen plasma administered during a plasma exchange therapy on viscoelastic tests

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Minutes to No maximum

Healthy volunteers

Inclusion criteria

* patients undergoing therapeutic plasma exchange for autoimmune disease

Exclusion criteria

* previous coagulation disorders * anticoagulant or antiplatelet therapy within the last 7 days

Design outcomes

Primary

Measure	Time frame	Description
change in clotting time - CT (%)	one hour before compared to one hour after plasmaexchange	change in CT determined before and after plasmaexchange. A 20% change in parameter value will be considered clinically significant.

Secondary

Measure	Time frame	Description
change clot formation time - CFT (%)	one hour before compared to one hour after plasmaexchange	change in CFT determined before and after plasmaexchange. A 20% change in parameter value will be considered clinically significant.
change maximum clot firmness - MCF (%)	one hour before compared to one hour after plasmaexchange	change in MCF determined before and after plasmaexchange. A 20% change in parameter value will be considered clinically significant.

Countries

Romania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026