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

• Sponsor: Institutul Clinic Fundeni (Other)
• Overall Status: Completed
• CT.gov ID: NCT04513249
• Collaborator: (none)
• Enrollment: 25
• Location: 1
• Actual Duration (Months): 7.7
• Patients Per Site Per Month: 3.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Transfusion Related Complication	Diagnostic Test: dynamics of coagulation parameters

Study Design

• Study Type: Observational
• Actual Enrollment: 25 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Effects of Therapeutic Plasmaexhange on Viscoelastic Tests in Non-coagulopathic Patients
• Actual Study Start Date: May 10, 2017
• Actual Primary Completion Date: Dec 30, 2017
• Actual Study Completion Date: Dec 30, 2017

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Minutes and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• patients undergoing therapeutic plasma exchange for autoimmune disease

Exclusion Criteria:

• previous coagulation disorders

• anticoagulant or antiplatelet therapy within the last 7 days

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fundeni Clinical Institute	Bucharest		Romania	022328

Sponsors and Collaborators

• Institutul Clinic Fundeni

Investigators

• Study Chair: Dana Tomescu, Prof, Fundeni Clinical Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Popescu Mihai, Clinical Professor, Institutul Clinic Fundeni
• ClinicalTrials.gov Identifier: NCT04513249
• Other Study ID Numbers: FFP
• First Posted: Aug 14, 2020
• Last Update Posted: Aug 14, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Aug 14, 2020