Intraoperative BleedingPhase 3FibstudLTNCT01539057
The Efficacy of the Administration of Fibrinogen in Liver Transplantation
A Phase 3 study testing Fibrinogen and Saline in people with Intraoperative Bleeding, run by Hospital Universitari de Bellvitge at 4 sites in Spain.
Trial summary
Objective: To evaluate the efficacy of preoperative administration of fibrinogen in liver transplantation by maintaining a preoperative plasma level equal to 2.9 g / L compared with placebo, reflecting a reduction in the number of RBC units transfused during the procedure. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Intraoperative Bleeding
- What is being tested?
- Fibrinogen and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 4 sitesSpain
- Study dates
- Jul 2012to Jan 2015
- Phase
- Phase 3
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients candidates for liver transplantation
- Patients with a value of pre-transplant plasma fibrinogen less than 2.9 g / L.
Who cannot join
- Patients with a value of fibrinogen in the 24 hours prior to the intervention than 2.9 g / L.
- Known history of thromboembolic events in 30 days
- Known or suspected pregnancy
- Previous randomization in this trial
- Known or suspected allergy to trial products or related products
- Known presence of congenital bleeding disorder. Patients treated with aspirin, warfarin
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- The following indications for transplantation: familial polyneuropathy, acute liver failure, biliary cirrhosis and sclerosing cholangitis, Budd-Chiari syndrome
- Heart beating donors and living donor
- Patient reluctant to participate in the trial
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
Hospital Universitari de Bellvitge
Barcelona, Barcelona, 08907
Hospital de Cruces
Bilbao, Vizcaya
Hospital Virgen de la Arrixaca
Murcia, Murcia
Hospital Virgen del Rocio
Seville, Sevilla
About this study
Official title: A Multicenter, Placebo Controlled Study to Evaluate the Efficacy of the Administration of Fibrinogen on Blood Product Requirements in Liver Transplantation
Objective:
- To evaluate the efficacy of preoperative administration of fibrinogen in liver transplantation by maintaining a preoperative plasma level equal to 2.9 g / L compared with placebo, reflecting a reduction in the number of RBC units transfused during the procedure.
- To determine the influence of fibrinogen administration on mortality and survival of liver graft evaluated one year after the procedure.
- To determine the safety of fibrinogen administration recording thrombotic complications evaluated during hospitalization or at least 30 days postoperatively.
Read the detailed description
Methods: A multicenter, randomized, double-blind, placebo-controlled study. One hundred thirty two patients (132) will randomly be assigned to:
Treatment group, Fibrinogen administration; doses of fibrinogen: 1 g for an increase in the plasmatic value of fibrinogen of 0.29 g / L to obtain a value of 2.9 g / L.
Placebo group, to whom the same dose volume of saline will be administered.
Determinations of haematocrit, electrolytes and kidney function tests and coagulation and haemostasis and thrombelastography test are made at all stages of the proceeding. A standard protocol for intraoperative management will be applied. Blood loss, administration of blood products, fluid therapy, presence of reperfusion syndrome, operative complications and mortality and survival will be registered. Patients will be followed for one year after transplantation.
- Conditions
- Intraoperative Bleeding
- Being tested
- Fibrinogen, Saline
- Keywords
- Liver, Surgery, hemostasis, coagulation, Fibrinogen
- Medical subject headings
- Blood Loss, Surgical, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FibrinogenDrug
Also called Haemocomplettan, RiaSTAP
The dose of fibrinogen should be calculated at 1 g of fibrinogen in order to obtain an increase in plasma fibrinogen value of 0.29 g / L to reach a final value of 2.9 g / L.
Fibrinogen ampoules powder prepared with water dilution and located in a serum at a concentration of 2g/100 ml, which will be administered by intravenous infusion for 10 minutes.
Administration before surgery starts
SalineDrug
Also called physiologic serum
the same dose in volume of water dilution will be administered. The potential dose of fibrinogen required to obtain a final plasmatic reading of 2.9 g / L. will be computed. A serum will contain the corresponding ml of water dilution. Administered before surgery starts
| Study group | Role | What they receive |
|---|---|---|
| Intravenous Fibrinogen | Experimental | Fibrinogen will be administered until an expected plasmatic value of 2.9 g / L is achieved. Receives: Drug: Fibrinogen |
| Saline Serum | Placebo comparator | the same dose in volume of saline dilution will be administered. The potential dose of fibrinogen required to obtain a final plasmatic reading of 2.9 g / L. will be computed. A serum will contain the corresponding ml of saline dilution Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients requiring transfusion of packed red blood cells during the procedure
record of number of red blood cell packeds transfused during the surgical procedure
Measured: intraoperative
Secondary outcomes (3)
Percentage of patients requiring blood products other than red cell concentrates
- Number of packed red cells transfused during surgery
- Number of units of fresh frozen plasma transfused during surgery
- Number of platelet units transfused during surgery
- Grams of fibrinogen administered during surgery
Measured: intraoperative
Operative outcome
- Operative mortality
- Liver graft survival
- Thrombotic complications of all types and causes
Measured: 4 weeks
liver transplantation outcome
Follow-up of graft survival and patient mortality one year after liver transplantation.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2012 (estimated)
- Study startJul 2012
- Primary completionSep 2013
- Study completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Intraoperative BleedingStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari de Bellvitge
- Sponsor type
- University, hospital or other
- Collaborators
- Spanish Clinical Research Network - SCReN
- Responsible party
- Principal investigator, Antoni Sabate, Hospital Universitari de Bellvitge
- Investigators
- Antoni Sabate, MD, Study director, Hospital Universitari Bellvitge.IDIBELL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01539057
- Sponsor's protocol ID
- Promotor Code 1553-H-459
- Other IDs
- 2010-024584-41
- Acronym
- FibstudLT
- Status last verified
- Dec 2014
- First submitted
- 2 Feb 2012
- Last updated
- 4 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Perez L, Sabate A, Gutierrez R, Caballero M, Pujol R, Llaurado S, Penafiel J, Hereu P, Blasi A. Risk factors associated with blood transfusion in liver transplantation. Sci Rep. 2024 Aug 16;14(1):19022. doi: 10.1038/s41598-024-70078-2.
PubMed 39152310Caballero M, Sabate A, Perez L, Vidal J, Reverter E, Gutierrez R, Crespo G, Penafiel J, Blasi A. Factors associated with mechanical ventilation longer than 24 h after liver transplantation in patients at risk for bleeding. BMC Anesthesiol. 2023 Nov 2;23(1):356. doi: 10.1186/s12871-023-02321-8.
PubMed 37919695Blasi A, Sabate A, Beltran J, Costa M, Reyes R, Torres F. Correlation between plasma fibrinogen and FIBTEM thromboelastometry during liver transplantation: a comprehensive assessment. Vox Sang. 2017 Nov;112(8):788-795. doi: 10.1111/vox.12598. Epub 2017 Oct 8.
PubMed 28990201Sabate A, Gutierrez R, Beltran J, Mellado P, Blasi A, Acosta F, Costa M, Reyes R, Torres F. Impact of Preemptive Fibrinogen Concentrate on Transfusion Requirements in Liver Transplantation: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial. Am J Transplant. 2016 Aug;16(8):2421-9. doi: 10.1111/ajt.13752. Epub 2016 Mar 17.
PubMed 26880105
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Placebo Controlled Study to Evaluate the Efficacy of the Administration of Fibrinogen on Blood Product Requirements in Liver Transplantation
- ClinicalTrials.gov ID
- NCT01539057
- Acronym / sponsor ID
- FibstudLT / Promotor Code 1553-H-459
- Conditions
- Intraoperative Bleeding
- Keywords
- Liver, Surgery, hemostasis, coagulation, Fibrinogen
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Hospital Universitari de BellvitgeUniversity, hospital or other
- Collaborators
- Spanish Clinical Research Network - SCReN
- Study start
- Jul 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Jan 2015 (estimated)
- First posted
- 27 Feb 2012 (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.
Objective:
- To evaluate the efficacy of preoperative administration of fibrinogen in liver transplantation by maintaining a preoperative plasma level equal to 2.9 g / L compared with placebo, reflecting a reduction in the number of RBC units transfused during the procedure.
- To determine the influence of fibrinogen administration on mortality and survival of liver graft evaluated one year after the procedure.
- To determine the safety of fibrinogen administration recording thrombotic complications evaluated during hospitalization or at least 30 days postoperatively.
Detailed description
Methods: A multicenter, randomized, double-blind, placebo-controlled study. One hundred thirty two patients (132) will randomly be assigned to:
Treatment group, Fibrinogen administration; doses of fibrinogen: 1 g for an increase in the plasmatic value of fibrinogen of 0.29 g / L to obtain a value of 2.9 g / L.
Placebo group, to whom the same dose volume of saline will be administered.
Determinations of haematocrit, electrolytes and kidney function tests and coagulation and haemostasis and thrombelastography test are made at all stages of the proceeding. A standard protocol for intraoperative management will be applied. Blood loss, administration of blood products, fluid therapy, presence of reperfusion syndrome, operative complications and mortality and survival will be registered. Patients will be followed for one year after transplantation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous Fibrinogen | Experimental | Drug: FibrinogenFibrinogen will be administered until an expected plasmatic value of 2.9 g / L is achieved. |
| Saline Serum | Placebo comparator | Drug: Salinethe same dose in volume of saline dilution will be administered. The potential dose of fibrinogen required to obtain a final plasmatic reading of 2.9 g / L. will be computed. A serum will contain the corresponding ml of saline dilution |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients candidates for liver transplantation
- Patients with a value of pre-transplant plasma fibrinogen less than 2.9 g / L.
Key exclusion criteria (9 listed)
- Patients with a value of fibrinogen in the 24 hours prior to the intervention than 2.9 g / L.
- Known history of thromboembolic events in 30 days
- Known or suspected pregnancy
- Previous randomization in this trial
- Known or suspected allergy to trial products or related products
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 |
|---|---|---|
| FibrinogenAlso: Haemocomplettan, RiaSTAPThe dose of fibrinogen should be calculated at 1 g of fibrinogen in order to obtain an increase in plasma fibrinogen value of 0.29 g / L to reach a final value of 2.9 g / L. Fibrinogen ampoules powder prepared with water dilution and located in a serum at a concentration of 2g/100 ml, which will be administered by intravenous infusion for 10 minutes. Administration before surgery starts | Drug | Intravenous Fibrinogen |
| SalineAlso: physiologic serumthe same dose in volume of water dilution will be administered. The potential dose of fibrinogen required to obtain a final plasmatic reading of 2.9 g / L. will be computed. A serum will contain the corresponding ml of water dilution. Administered before surgery starts | Drug | Saline Serum |
Primary outcome
Percentage of patients requiring transfusion of packed red blood cells during the procedure
Time frame: intraoperative
record of number of red blood cell packeds transfused during the surgical procedure
3 secondary outcomes
Percentage of patients requiring blood products other than red cell concentrates
Time frame: intraoperative
Operative outcome
Time frame: 4 weeks
liver transplantation outcome
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2014.
- Derived from this study: PubMed 39152310Perez L, Sabate A, Gutierrez R, Caballero M, Pujol R, Llaurado S, Penafiel J, Hereu P, Blasi A. Risk factors associated with blood transfusion in liver transplantation. Sci Rep. 2024 Aug 16;14(1):19022. doi: 10.1038/s41598-024-70078-2.
- Derived from this study: PubMed 37919695Caballero M, Sabate A, Perez L, Vidal J, Reverter E, Gutierrez R, Crespo G, Penafiel J, Blasi A. Factors associated with mechanical ventilation longer than 24 h after liver transplantation in patients at risk for bleeding. BMC Anesthesiol. 2023 Nov 2;23(1):356. doi: 10.1186/s12871-023-02321-8.
- Derived from this study: PubMed 28990201Blasi A, Sabate A, Beltran J, Costa M, Reyes R, Torres F. Correlation between plasma fibrinogen and FIBTEM thromboelastometry during liver transplantation: a comprehensive assessment. Vox Sang. 2017 Nov;112(8):788-795. doi: 10.1111/vox.12598. Epub 2017 Oct 8.
- Derived from this study: PubMed 26880105Sabate A, Gutierrez R, Beltran J, Mellado P, Blasi A, Acosta F, Costa M, Reyes R, Torres F. Impact of Preemptive Fibrinogen Concentrate on Transfusion Requirements in Liver Transplantation: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial. Am J Transplant. 2016 Aug;16(8):2421-9. doi: 10.1111/ajt.13752. Epub 2016 Mar 17.
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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.
Antoni Sabate, MD study director
Hospital Universitari Bellvitge.IDIBELL
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fibrinogen and Saline in people with Intraoperative Bleeding, run by Hospital Universitari de Bellvitge at 4 sites in Spain.
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 2 inclusion and 9 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 4 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Percentage of patients requiring transfusion of packed red blood cells during the procedure (time frame: intraoperative). 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 NCT01539057, which also lists 4 linked publications.
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 4 Dec 2014.