Bleeding in Liver TransplantationPhase 4NCT00235183
Plasma Transfusion in Liver Transplantation
A Phase 4 study testing plasma in people with Bleeding in Liver Transplantation, run by Etablissement Français du Sang at 1 site in France.
Trial summary
The aim of the study is to compare the clinical efficacy of three types of plasma secured on the viral level either by quarantine or by chemical treatment in patients undergoing liver transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bleeding in Liver Transplantation
- What is being tested?
- plasma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2005to Dec 2010
- Phase
- Phase 4
- 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
- age 18 yo and above
- consent is signed,
- liver transplantation is indicated,
- plasma is transfused
Who cannot join
- multiorgan transplantation (except combined kidney and liver transplantation)
- allergy to methylene blue.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Plasma Transfusion in Liver Transplantation : a Randomized, Double Blind, Multicenter Trial of Methylene Blue, Solvent/Detergent and Quarantined Plasma.
The aim of the study is to compare the clinical efficacy of three types of plasma secured on the viral level either by quarantine or by chemical treatment in patients undergoing liver transplantation.
Read the detailed description
Three types of plasma are transfused in bleeding patients undergoing liver transplantation:
- quarantined plasma,
- methylene blue treated plasma,
- solvent/detergent plasma. The main purpose is to show that the volume of methylene blue treated plasma consumed intraoperatively is equivalent to that of the 2 other types of plasma.
In addition, the correction of coagulation abnormalities are studied.
- Conditions
- Bleeding in Liver Transplantation
- Being tested
- plasma
- Keywords
- plasma, bleeding, liver transplantation
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plasmaOther
transfusion of more than 15 mL/Kg of plasma
| Study group | Role | What they receive |
|---|---|---|
| Quarantined FFP | Active comparator | Quarantined FFP Receives: Other: plasma |
| Methylene blue FFP | Active comparator | Methylene blue FFP Receives: Other: plasma |
| Solvent detergent FFP | Active comparator | Solvent detergent FFP Receives: Other: plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume of transfused plasma during surgery
Measured: 5 years
Secondary outcomes (2)
correction of coagulation abnormalities
Measured: 5 years
immediate and delayed adverse events
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2005 (estimated)
- Study startJun 2005
- Primary completionDec 2009
- Study completionDec 2010
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 Bleeding in Liver TransplantationStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Etablissement Français du Sang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yves Ozier, MD, PhD, Principal investigator, Hôpital Cochin, Paris, FranceEmmanuel Samain, MD, PhD, Principal investigator, hôpital Jean Minjoz, Besançon, FranceMarie - Christine Gillon, MD, Principal investigator, Hôpital Paul Brousse, Villejuif, FranceLoïc Villalon, MD, Principal investigator, Hôpital Pontchaillou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00235183
- Sponsor's protocol ID
- EFS plasma trial
- Status last verified
- Feb 2014
- First submitted
- 6 Oct 2005
- Last updated
- 17 Feb 2014
- Results posted
- No
Publications
Bartelmaos T, Chabanel A, Leger J, Villalon L, Gillon MC, Rouget C, Gomola A, Denninger MH, Tardivel R, Naegelen C, Courtois F, Bardiaux L, Giraudeau B, Ozier Y. Plasma transfusion in liver transplantation: a randomized, double-blind, multicenter clinical comparison of three virally secured plasmas. Transfusion. 2013 Jun;53(6):1335-45. doi: 10.1111/j.1537-2995.2012.03895.x. Epub 2012 Sep 24.
PubMed 22998014
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Transfusion in Liver Transplantation : a Randomized, Double Blind, Multicenter Trial of Methylene Blue, Solvent/Detergent and Quarantined Plasma.
- ClinicalTrials.gov ID
- NCT00235183
- Acronym / sponsor ID
- EFS plasma trial
- Conditions
- Bleeding in Liver Transplantation
- Keywords
- plasma, bleeding, liver transplantation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Etablissement Français du SangUniversity, hospital or other
- Study start
- Jun 2005
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 10 Oct 2005 (estimated)
- 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.
The aim of the study is to compare the clinical efficacy of three types of plasma secured on the viral level either by quarantine or by chemical treatment in patients undergoing liver transplantation.
Detailed description
Three types of plasma are transfused in bleeding patients undergoing liver transplantation:
- quarantined plasma,
- methylene blue treated plasma,
- solvent/detergent plasma. The main purpose is to show that the volume of methylene blue treated plasma consumed intraoperatively is equivalent to that of the 2 other types of plasma.
In addition, the correction of coagulation abnormalities are studied.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Quarantined FFP | Active comparator | Other: plasmaQuarantined FFP |
| Methylene blue FFP | Active comparator | Other: plasmaMethylene blue FFP |
| Solvent detergent FFP | Active comparator | Other: plasmaSolvent detergent FFP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 18 yo and above
- consent is signed,
- liver transplantation is indicated,
- plasma is transfused
Key exclusion criteria (2 listed)
- multiorgan transplantation (except combined kidney and liver transplantation)
- allergy to methylene blue.
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 |
|---|---|---|
| plasmatransfusion of more than 15 mL/Kg of plasma | Other | Methylene blue FFP, Quarantined FFP, Solvent detergent FFP |
Primary outcome
Volume of transfused plasma during surgery
Time frame: 5 years
2 secondary outcomes
correction of coagulation abnormalities
Time frame: 5 years
immediate and delayed adverse events
Time frame: 15 days
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 17 Feb 2014.
- Derived from this study: PubMed 22998014Bartelmaos T, Chabanel A, Leger J, Villalon L, Gillon MC, Rouget C, Gomola A, Denninger MH, Tardivel R, Naegelen C, Courtois F, Bardiaux L, Giraudeau B, Ozier Y. Plasma transfusion in liver transplantation: a randomized, double-blind, multicenter clinical comparison of three virally secured plasmas. Transfusion. 2013 Jun;53(6):1335-45. doi: 10.1111/j.1537-2995.2012.03895.x. Epub 2012 Sep 24.
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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.
Yves Ozier, MD, PhD principal investigator
Hôpital Cochin, Paris, France
Emmanuel Samain, MD, PhD principal investigator
hôpital Jean Minjoz, Besançon, France
Marie - Christine Gillon, MD principal investigator
Hôpital Paul Brousse, Villejuif, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing plasma in people with Bleeding in Liver Transplantation, run by Etablissement Français du Sang at 1 site in France.
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 4 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 17 Feb 2014. 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 France. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Volume of transfused plasma during surgery (time frame: 5 years). 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 NCT00235183, 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 17 Feb 2014.