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

Completed

• Conditions: Transfusion Related Complication

• Registration Number: NCT04513249
• Lead Sponsor: Institutul Clinic Fundeni

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-10
• Primary Completion: 2017-12-30
• Study Completion: 2017-12-30
• Status Verified: 2020-08
• Study First Submitted: 2020-08-11
• Study First Submitted QC: 2020-08-12
• Last Update Submitted: 2020-08-12
• Study First Posted: 2020-08-14
• Last Update Posted: 2020-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• patients undergoing therapeutic plasma exchange for autoimmune disease

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Fundeni Clinical Institute; 🇷🇴 Bucharest, Romania