Humoral RejectionNCT03801135
Changes in Haemostasis After Therapeutic Plasmapheresis With Citrate Anticoagulation
A study testing Fibrinogen concentrate and Fresh Frozen Plasma in people with Humoral Rejection and Guillain-Barre Syndrome, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
Plasma exchange procedures remove procoagulant and anticoagulant factors. Every procedure increases the risk of bleeding and repeated procedures increase the risk of bleeding mostly because lower fibrinogen levels. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Humoral Rejection, Guillain-Barre Syndrome, Miller Fisher Syndrome
- What is being tested?
- Fibrinogen concentrate and Fresh Frozen Plasma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSlovenia
- Study dates
- 3 Oct 2018to 24 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Every patient who will need repeated plasmapheresis treatment in UKC Ljubljana
Who cannot join
- pregnancy
- coagulation disorders
- Hypertriglyceridemia-induced acute pancreatitis
- hepatic disorders
Trial locations and contacts
1 site in 1 country.
Slovenia1 site, 1 recruiting
- Recruiting
University Medical Centre Ljubljana
Ljubljana, Gorenjska, 1000
Matej Zrimsek, +38631789714, matej.zrimsek@kclj.si
About this study
Official title: A Prospective Interventional Study to Investigate Changes in Haemostasis After Therapeutic Plasmapheresis With Citrate Anticoagulation With or Without Coagulation Factors Replacement
Plasma exchange procedures remove procoagulant and anticoagulant factors. Every procedure increases the risk of bleeding and repeated procedures increase the risk of bleeding mostly because lower fibrinogen levels. The aim of study is to define coagulation status of patient after plasmapheresis with different laboratory tests and to investigate the possibility of fibrinogen concentrate replacement for the correction of induced coagulation disorder.
- Conditions
- Humoral Rejection, Guillain-Barre Syndrome, Miller Fisher Syndrome, CIDP, Good Pasture Syndrome, Hyperviscosity Syndrome
- Being tested
- Fibrinogen concentrate, Fresh Frozen Plasma
- Keywords
- Fibrinogen concentrate, Fresh frozen plasma, ROTEM, Fibrinogen, Overall coagulation potential
- Medical subject headings
- Guillain-Barre Syndrome, Miller Fisher Syndrome, Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, Anti-Glomerular Basement Membrane Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibrinogen concentrateDrug
Also called Haemocomplettan
Haemocomplettan will be infused after plasma exchange procedure
Fresh Frozen PlasmaOther
Fresh frozen plasma will be part of replacement fluid
| Study group | Role | What they receive |
|---|---|---|
| Electrolyte&Albumin Group | No intervention | One calculated plasma volume will be replaced with a mixture of electrolyte replacement solution and albumin. |
| Fibrinogen Treatment Group | Experimental | One calculated plasma volume will be replaced with a mixture of electrolyte replacement solution and albumin. Fibrinogen concentrate will be infused afterwards. Receives: Drug: Fibrinogen concentrate |
| FFP Treatment Group | Active comparator | One calculated plasma volume will be replaced with a mixture of electrolyte replacement solution, albumin and fresh frozen plasma. Receives: Other: Fresh Frozen Plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of plasmapheresis replacement fluid type on fibrinogen level
Change of fibrinogen level after plasmapheresis treatment depending on replacement fluid type
Measured: Right after every plasmapheresis session, during the whole plasmapheresis treatment (usually about 2 weeks)]
Secondary outcomes (2)
Effect on coagulation tests after plasmapheresis - ROTEM EXTEM
ROTEM (EXTEM MCF) change after plasmapheresis treatment depending on replacement fluid type
Measured: Right after every plasmapheresis session, during the whole plasmapheresis treatment (usually about 2 weeks)]
Effect on coagulation tests after plasmapheresis - ROTEM FIBTEM
ROTEM (FIBTEM MCF) change after plasmapheresis treatment depending on replacement fluid type
Measured: Right after every plasmapheresis session, during the whole plasmapheresis treatment (usually about 2 weeks)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2019
- Study start3 Oct 2018
- Primary completion1 Sep 2019 (estimated)
- Study completion24 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Humoral RejectionStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matej Zrimsek, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03801135
- Sponsor's protocol ID
- MPFhemostaza
- Status last verified
- Jan 2019
- First submitted
- 4 Oct 2018
- Last updated
- 11 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zrimsek M, Gubensek J, Marn Pernat A. A Pilot Study on the Replacement of Fibrinogen with Fibrinogen Concentrates During Therapeutic Plasma Exchange with Mild to Moderate Bleeding Risk-A Comparison with Fresh Frozen Plasma and Albumin Replacement. J Clin Med. 2024 Dec 16;13(24):7662. doi: 10.3390/jcm13247662.
PubMed 39768590
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Interventional Study to Investigate Changes in Haemostasis After Therapeutic Plasmapheresis With Citrate Anticoagulation With or Without Coagulation Factors Replacement
- ClinicalTrials.gov ID
- NCT03801135
- Acronym / sponsor ID
- MPFhemostaza
- Conditions
- Humoral Rejection, Guillain-Barre Syndrome, Miller Fisher Syndrome, CIDP, Good Pasture Syndrome, Hyperviscosity Syndrome
- Keywords
- Fibrinogen concentrate, Fresh frozen plasma, ROTEM, Fibrinogen, Overall coagulation potential
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 3 Oct 2018 (actual)
- Primary completion
- 1 Sep 2019 (estimated)
- Study completion
- 24 Sep 2019 (estimated)
- First posted
- 11 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Plasma exchange procedures remove procoagulant and anticoagulant factors. Every procedure increases the risk of bleeding and repeated procedures increase the risk of bleeding mostly because lower fibrinogen levels. The aim of study is to define coagulation status of patient after plasmapheresis with different laboratory tests and to investigate the possibility of fibrinogen concentrate replacement for the correction of induced coagulation disorder.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Electrolyte&Albumin Group | No intervention | –One calculated plasma volume will be replaced with a mixture of electrolyte replacement solution and albumin. |
| Fibrinogen Treatment Group | Experimental | Drug: Fibrinogen concentrateOne calculated plasma volume will be replaced with a mixture of electrolyte replacement solution and albumin. Fibrinogen concentrate will be infused afterwards. |
| FFP Treatment Group | Active comparator | Other: Fresh Frozen PlasmaOne calculated plasma volume will be replaced with a mixture of electrolyte replacement solution, albumin and fresh frozen plasma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Every patient who will need repeated plasmapheresis treatment in UKC Ljubljana
Key exclusion criteria (4 listed)
- pregnancy
- coagulation disorders
- Hypertriglyceridemia-induced acute pancreatitis
- hepatic disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fibrinogen concentrateAlso: HaemocomplettanHaemocomplettan will be infused after plasma exchange procedure | Drug | Fibrinogen Treatment Group |
| Fresh Frozen PlasmaFresh frozen plasma will be part of replacement fluid | Other | FFP Treatment Group |
Primary outcome
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)]
Change of fibrinogen level after plasmapheresis treatment depending on replacement fluid type
2 secondary outcomes
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)]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2019.
- Derived from this study: PubMed 39768590Zrimsek M, Gubensek J, Marn Pernat A. A Pilot Study on the Replacement of Fibrinogen with Fibrinogen Concentrates During Therapeutic Plasma Exchange with Mild to Moderate Bleeding Risk-A Comparison with Fresh Frozen Plasma and Albumin Replacement. J Clin Med. 2024 Dec 16;13(24):7662. doi: 10.3390/jcm13247662.
- Individual participant dataSharing planned: Undecided
Related trials for Humoral Rejection
RecruitingObservational study
Tissue Study on the Chronic Active Humoral Rejection (cAMR) Population of Kidney Transplantation
Kidney Transplant
Not yet recruitingObservational study
Study of Alloimmune Response in Humoral Rejection After Kidney Transplantation
Kidney Transplantation, Kidney Allograft Biopsy
Not yet recruitingObservational study
Study of the Pathogenicity and Humoral Immune Response Induced by BK Virus in Lung Transplant Recipients
Renal-urinary Impairment, Graft Rejection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fibrinogen concentrate and Fresh Frozen Plasma in people with Humoral Rejection and Guillain-Barre Syndrome, run by University Medical Centre Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matej Zrimsek (+38631789714, matej.zrimsek@kclj.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03801135, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2019.