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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03801135
Date of registration: 04/10/2018
Prospective Registration: Yes
Primary sponsor: University Medical Centre Ljubljana
Public title: Changes in Haemostasis After Therapeutic Plasmapheresis With Citrate Anticoagulation
Scientific title: A Prospective Interventional Study to Investigate Changes in Haemostasis After Therapeutic Plasmapheresis With Citrate Anticoagulation With or Without Coagulation Factors Replacement
Date of first enrolment: October 3, 2018
Target sample size: 20
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT03801135
Study type:  Interventional
Study design:  Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).  
Phase:  N/A
Countries of recruitment
Slovenia
Contacts
Name:     Matej Zrimsek
Address: 
Telephone: +38631789714
Email: matej.zrimsek@kclj.si
Affiliation: 
Name:     Matej Zrimsek
Address: 
Telephone: +38631789714
Email: matej.zrimsek@kclj.si
Affiliation: 
Key inclusion & exclusion criteria

Inclusion Criteria:

- Every patient who will need repeated plasmapheresis treatment in UKC Ljubljana

Exclusion Criteria:

- pregnancy

- coagulation disorders

- Hypertriglyceridemia-induced acute pancreatitis

- hepatic disorders



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
CIDP
Good Pasture Syndrome
Guillain-Barre Syndrome
Humoral Rejection
Hyperviscosity Syndrome
Miller Fisher Syndrome
Intervention(s)
Drug: Fibrinogen concentrate
Other: Fresh Frozen Plasma
Primary Outcome(s)
Effect of plasmapheresis replacement fluid type on fibrinogen level [Time Frame: Right after every plasmapheresis session, during the whole plasmapheresis treatment (usually about 2 weeks)]]
Secondary Outcome(s)
Effect on coagulation tests after plasmapheresis - ROTEM EXTEM [Time Frame: Right after every plasmapheresis session, during the whole plasmapheresis treatment (usually about 2 weeks)]]
Effect on coagulation tests after plasmapheresis - ROTEM FIBTEM [Time Frame: Right after every plasmapheresis session, during the whole plasmapheresis treatment (usually about 2 weeks)]]
Secondary ID(s)
MPFhemostaza
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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