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

August 12, 2020 updated by: Popescu Mihai, Institutul Clinic Fundeni
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Romania
      • Bucharest, Romania, 022328
        • Fundeni Clinical Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 minutes and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

consecutive patients undergoing therapeutic plasmaechange for autoimmune disease

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in clotting time - CT (%)
Time Frame: 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.
one hour before compared to one hour after plasmaexchange

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change clot formation time - CFT (%)
Time Frame: 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.
one hour before compared to one hour after plasmaexchange
change maximum clot firmness - MCF (%)
Time Frame: 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.
one hour before compared to one hour after plasmaexchange

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institutul Clinic Fundeni

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2017

Primary Completion (Actual)

December 30, 2017

Study Completion (Actual)

December 30, 2017

Study Registration Dates

First Submitted

August 11, 2020

First Submitted That Met QC Criteria

August 12, 2020

First Posted (Actual)

August 14, 2020

Study Record Updates

Last Update Posted (Actual)

August 14, 2020

Last Update Submitted That Met QC Criteria

August 12, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • FFP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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