Clinical Trials Logo
  1. Home
  2. Transfusion Related Complication
  3. NCT04513249
  4. Details
NCT04513249 Clinical Trial

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

Transfusion Related Complication Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04513249
Other study ID # FFP
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 10, 2017
Est. completion date December 30, 2017

Study information
Verified date August 2020
Source Institutul Clinic Fundeni
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 25
Est. completion date December 30, 2017
Est. primary completion date December 30, 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• dynamics of coagulation parameters
the effects of fresh frozen plasma administered during a plasma exchange therapy on viscoelastic tests

Locations
Country Name City State
Romania Fundeni Clinical Institute Bucharest

Sponsors (1)
Lead Sponsor Collaborator
Institutul Clinic Fundeni

Country where clinical trial is conducted

Romania, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 change clot formation time - CFT (%) 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
Secondary change maximum clot firmness - MCF (%) 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
See also
  Status Clinical Trial Phase
Recruiting NCT05699005 - Individualized or Conventional Transfusion Strategies During Peripheral VA-ECMO Phase 1
Recruiting NCT06403163 - Transfusion Surveillance in Anaesthesia
Not yet recruiting NCT02587845 - Use of Transexamic Acid in Hip Replacement Phase 3
Completed NCT03365999 - Oral Tranexamic Acid vs. Oral Aminocaproic Acid to Reduce Blood Loss and Transfusion After Total Knee Replacement. Phase 2
Completed NCT03784794 - Patient Blood Management for Massive Obstetric Hemorrhage N/A
Not yet recruiting NCT02139995 - West-China Transfusion Score for Critically-ill Patients Phase 3
Not yet recruiting NCT03934112 - Impact of Transfusional Practice on the Morbidity and Mortality of Patients in Intensive Care Unit
Completed NCT03394274 - Restrictive Versus Liberal Transfusion, Major Surgeries N/A
Not yet recruiting NCT06399536 - Individualized ANH for Non-cardiac Surgery N/A
Withdrawn NCT04388722 - Monitoring Noninvasively for Infusion and Transfusion Optimization N/A
Completed NCT03476005 - Proficiency Based Training to Investigate WBIT N/A
Recruiting NCT03999229 - S-Nitrosylation (SNO) Therapy During Autologous Blood Transfusion Phase 1
Not yet recruiting NCT04413721 - Effects of Packed Red Blood Cell Storage Duration on Pediatric Living Donor Liver Transplantation N/A
Recruiting NCT02461264 - Transfusion Strategy in Hematological Intensive Care Unit Phase 3
Terminated NCT01915654 - Impact of RBC Transfusion Less Than 14 Days on Morbidity and Mortality in Cardiac Surgical Patients N/A
Not yet recruiting NCT05696210 - Evaluation of the 1-year Prognosis of Patients Under Veno-arterial Extracorporeal Membrane Oxygenation for Cardiogenic Shock With Blood Transfusion Requirement
Completed NCT04286984 - Implementation of a Patient Blood Management Program in Gastric Cancer Surgery
Completed NCT03764813 - Cord Blood Transfusion In Preterm Neonates (CB-TrIP)
Withdrawn NCT04383756 - Utilization of Donor Whole Blood for Blood Transfusion in Deceased Donor Liver Transplantation Early Phase 1
Completed NCT03815773 - PRospective Multicenter Observational Study on Transfusion Practice in Vv-ECMO Patients: The PROTECMO Study