Transfusion Related ComplicationNCT04513249
Effects of Therapeutic Plasmaexhange on Viscoelastic Tests in Non-coagulopathic Patients
An observational study of Transfusion Related Complication, run by Institutul Clinic Fundeni at 1 site in Romania.
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. Read more about this study
- Who is it for?
- Ages 18 minutes and older
- Conditions the study is for
- Transfusion Related Complication
- What is being tested?
- dynamics of coagulation parameters
- How many people
- 25 participants
- Where
- 1 siteRomania
- Study dates
- 10 May 2017to 30 Dec 2017
- Phase
- Observational
- 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 minutes and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: consecutive patients undergoing therapeutic plasmaechange for autoimmune disease
Who may be able to join
- patients undergoing therapeutic plasma exchange for autoimmune disease
Who cannot join
- previous coagulation disorders
- anticoagulant or antiplatelet therapy within the last 7 days
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Transfusion Related Complication
- Being tested
- dynamics of coagulation parameters
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dynamics of coagulation parametersDiagnostic test
the effects of fresh frozen plasma administered during a plasma exchange therapy on viscoelastic tests
What is being measured
The primary outcome is the main question the study is designed to answer.
change in clotting time - CT (%)
change in CT determined before and after plasmaexchange. A 20% change in parameter value will be considered clinically significant.
Measured: one hour before compared to one hour after plasmaexchange
Secondary outcomes (2)
change clot formation time - CFT (%)
change in CFT determined before and after plasmaexchange. A 20% change in parameter value will be considered clinically significant.
Measured: 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.
Measured: one hour before compared to one hour after plasmaexchange
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2020
- Study start10 May 2017
- Primary completion30 Dec 2017
- Study completion30 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transfusion Related ComplicationStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institutul Clinic Fundeni
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Popescu Mihai, Institutul Clinic Fundeni
- Investigators
- Dana Tomescu, Prof, Study chair, Fundeni Clinical Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04513249
- Sponsor's protocol ID
- FFP
- Status last verified
- Aug 2020
- First submitted
- 11 Aug 2020
- Last updated
- 14 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Therapeutic Plasmaexhange on Viscoelastic Tests in Non-coagulopathic Patients
- ClinicalTrials.gov ID
- NCT04513249
- Acronym / sponsor ID
- FFP
- Conditions
- Transfusion Related Complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Institutul Clinic FundeniUniversity, hospital or other
- Study start
- 10 May 2017 (actual)
- Primary completion
- 30 Dec 2017 (actual)
- Study completion
- 30 Dec 2017 (actual)
- First posted
- 14 Aug 2020 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 minutes and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- consecutive patients undergoing therapeutic plasmaechange for autoimmune disease
Key inclusion criteria (1 listed)
- patients undergoing therapeutic plasma exchange for autoimmune disease
Key exclusion criteria (2 listed)
- previous coagulation disorders
- anticoagulant or antiplatelet therapy within the last 7 days
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 |
|---|---|---|
| dynamics of coagulation parametersthe effects of fresh frozen plasma administered during a plasma exchange therapy on viscoelastic tests | Diagnostic test | – |
Primary outcome
change in clotting time - CT (%)
Time frame: one hour before compared to one hour after plasmaexchange
change in CT determined before and after plasmaexchange. A 20% change in parameter value will be considered clinically significant.
2 secondary outcomes
change clot formation time - CFT (%)
Time frame: one hour before compared to one hour after plasmaexchange
change maximum clot firmness - MCF (%)
Time frame: one hour before compared to one hour after plasmaexchange
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2020.
- Individual participant dataSharing planned: No
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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.
Dana Tomescu, Prof study chair
Fundeni Clinical Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transfusion Related Complication, run by Institutul Clinic Fundeni at 1 site in Romania.
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 2 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: finished, as of the sponsor's last update on 14 Aug 2020. 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 Romania. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in clotting time - CT (%) (time frame: one hour before compared to one hour after plasmaexchange). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Aug 2020.