An observational study in Transfusion Related Complication, sponsored by Institutul Clinic Fundeni. Completed at 1 site in Romania. Open to participants aged 18 Minutes and older. Per ClinicalTrials.gov, last updated 2020-08-14.
Sponsored by Institutul Clinic Fundeni · Observational
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.
Institutul Clinic Fundeni is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
consecutive patients undergoing therapeutic plasmaechange for autoimmune disease
Exclusion Criteria:
the effects of fresh frozen plasma administered during a plasma exchange therapy on viscoelastic tests
change in clotting time - CT (%)
change in CT determined before and after plasmaexchange. A 20% change in parameter value will be considered clinically significant.
Time frame: one hour before compared to one hour after plasmaexchange
change clot formation time - CFT (%)
change in CFT determined before and after plasmaexchange. A 20% change in parameter value will be considered clinically significant.
Time frame: one hour before compared to one hour after plasmaexchange
change maximum clot firmness - MCF (%)
change in MCF determined before and after plasmaexchange. A 20% change in parameter value will be considered clinically significant.
Time frame: one hour before compared to one hour after plasmaexchange
Plan to share: No
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This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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Institutul Clinic Fundeni