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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03801135 |
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Date of registration:
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04/10/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Changes in Haemostasis After Therapeutic Plasmapheresis With Citrate Anticoagulation
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Scientific title:
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A Prospective Interventional Study to Investigate Changes in Haemostasis After Therapeutic Plasmapheresis With Citrate Anticoagulation With or Without Coagulation Factors Replacement |
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Date of first enrolment:
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October 3, 2018 |
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Target sample size:
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20 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03801135 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Slovenia
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Contacts
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Name:
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Matej Zrimsek |
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Address:
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Telephone:
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+38631789714 |
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Email:
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matej.zrimsek@kclj.si |
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Affiliation:
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Name:
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Matej Zrimsek |
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Address:
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Telephone:
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+38631789714 |
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Email:
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matej.zrimsek@kclj.si |
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Affiliation:
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Guillain-Barre Syndrome
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CIDP
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Good Pasture Syndrome
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Miller Fisher Syndrome
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Hyperviscosity Syndrome
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Humoral Rejection
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Intervention(s)
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Drug: Fibrinogen concentrate
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Other: Fresh Frozen Plasma
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Primary Outcome(s)
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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)]]
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Secondary Outcome(s)
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Effect on coagulation tests after plasmapheresis - ROTEM EXTEM
[Time Frame: Right after every plasmapheresis session, during the whole plasmapheresis treatment (usually about 2 weeks)]]
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Effect on coagulation tests after plasmapheresis - ROTEM FIBTEM
[Time Frame: Right after every plasmapheresis session, during the whole plasmapheresis treatment (usually about 2 weeks)]]
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Secondary ID(s)
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MPFhemostaza
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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