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

NCT04513249 | Completed

• 1 other identifier: FFP
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Transfusion Related Complication

Outcome Measures

Primary Outcomes (1)

• change in clotting time - CT (%)

  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 Outcomes (2)

• change clot formation time - CFT (%)

  one hour before compared to one hour after plasmaexchange

• change maximum clot firmness - MCF (%)

  one hour before compared to one hour after plasmaexchange

Interventions

dynamics of coagulation parameters DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Minutes+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

consecutive patients undergoing therapeutic plasmaechange for autoimmune disease

You may qualify if:

• patients undergoing therapeutic plasma exchange for autoimmune disease

You may not qualify if:

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

Sponsors & Collaborators

• Institutul Clinic Fundeni: lead

Study Sites (1)

Fundeni Clinical Institute

Bucharest, 022328, Romania

Location

Study Officials

• Dana Tomescu, Prof

  Fundeni Clinical Institute

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: August 11, 2020
• First Posted: August 14, 2020
• Study Start: May 10, 2017
• Primary Completion: December 30, 2017
• Study Completion: December 30, 2017
• Last Updated: August 14, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)