Fibrin Blood ClotPhase 4NCT04405518
Impact of Two Guided Transfusion Strategies on Blood Product Requirements in Liver Transplantation.
A Phase 4 study testing Fibrinogen Concentrate (Human) 1 MG [RiaSTAP] in people with Fibrin Blood Clot, run by Antoni Sabaté Pes at 3 sites in Spain.
Trial summary
It is a national multicentre clinical study, where 3 hospitals are involved: Bellvitge University Hospital, Clinic Hospital of Barcelona and Cruces Hospital of Bilbao). It is a randomized study based on the Hemoglobin value of the patient with a 1:1 ratio, parallel groups, controlled and single blind, in patients… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Fibrin Blood Clot
- What is being tested?
- Fibrinogen Concentrate (Human) 1 MG [RiaSTAP]
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 3 sitesSpain
- Study dates
- 17 Jun 2019to 31 Oct 2022
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years.
- Candidate to an orthotopic liver trasnplantation.
- Informed consent.
- Preoperative hemoglobine </= 130 g/L
Who cannot join
- Preoperative hemoglobin> 130 g / L
- Familial amyloid polyneuropathy
- Polycystosis hepatic
- Living donor liver transplant
- Uncontrolled donor after cardiac death
- Acute / subacute liver failure
Show all 10Show fewer
- Re-transplant (in the same hospital admission)
- Use of Anticoagulation drugs before transplantation.
- Age <18 years.
- Pregnancy and lactation.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Clinic Hospital
Barcelona
Cruces Hospital
Bilbao, Vizcaya
Bellvitge Universitary Hospital
L'Hospitalet de Llobregat, Barcelone, 08907
About this study
Official title: Impact of Two Thromboelastometry-guided Transfusion Strategies on Blood Product Requirements in Liver Transplantation. a Multicenter, Randomized Trial. TROMBOFIBtrial
It is a national multicentre clinical study, where 3 hospitals are involved: Bellvitge University Hospital, Clinic Hospital of Barcelona and Cruces Hospital of Bilbao). It is a randomized study based on the Hemoglobin value of the patient with a 1:1 ratio, parallel groups, controlled and single blind, in patients undergoing an orthotopic liver transplant, confirming previously that the participants fulfill all the inclusion criteria and none of exclusion.
Read the detailed description
A total of 176 patients will be included (88 per group) and each center can not include more than 40% of the sample to avoid bias.
Blood samples will be analyzed at different times of the surgical intervention by an electronic device called thromboelastogram. It evaluates the blood clot characteristics and, depending on the results, assesses the need to correct values by the administration of fibrinogen or platelets.
One of the coagulation parameter evaluated and corrected by thromboelastogram is called A10FIBTEM. In a previous study, the investigators have seen that maintaining some specific ranges in the A10FIBTEM, results in a decrease of the use of blood products. That's why the investigators have created 2 groups:
- The control group will be corrected up to a value of A10FIBTEM = 8mm.
- The intervention group will be corrected up to a value of A10FIBTEM = 11mm.
Subsequently, results between groups will be compared. The investigators have to consider that the drug used in this study (Riastap) is an authorized and commercial drug.
The main objective is to demonstrate that the administration of fibrinogen in the intervention group compared to the control group changes the administration of red blood cells pack during the liver transplant and in the first 24 hours after.
Secondary objectives consist in demonstrate that in the intervention group, there is also a change in the administration of other blood products, a change in acute renal damage, a change in hours of mechanical ventilation, no changes in thrombotic events in the hepatic graft or in the patient in the first 90 days of the liver transplant and no changes in re operations, re-transplantation, or mortality during the first 90 days of the liver transplant, compared to the control group.
- Conditions
- Fibrin Blood Clot
- Being tested
- Fibrinogen Concentrate (Human) 1 MG [RiaSTAP]
- Keywords
- fibrinogen, red blood cell pack transfusion, orthotopic liver transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibrinogen Concentrate (Human) 1 MG [RiaSTAP]Drug
The drug used in this study is Riastap, 1g (Fibrinogen). The dose administered will depend on the arm group assigned and in the results of the thromboelastogram during the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | The doses of fibrinogen will be calculated acording to the formula based on previous study (AJT2017), rounded to the higher value according to the presentation format of the drug. Study medication will be stored at the hospital pharmacy.
Formula: 8mm - A10FIBTEM registered in mm) x 1.1 = fibrinogen dose required Receives: Drug: Fibrinogen Concentrate (Human) 1 MG [RiaSTAP] |
| intervention group | Experimental | The doses of fibrinogen will be calculated acording to the formula based on previous study (AJT2017), rounded to the higher value according to the presentation format of the drug. Study medication will be stored at the hospital pharmacy.
Formula: 11mm - A10FIBTEM registered in mm) x 1.1 = fibrinogen dose required Receives: Drug: Fibrinogen Concentrate (Human) 1 MG [RiaSTAP] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the rate of red blood cell packs transfusion during procedure and in the first 24hours after between groups.
Demonstrate that the A10FIBTEM correction with the administration of fibrinogen up to an A10FIBTEM value of 11mm, change the administration of red blood cell pack during the procedure and in the first 24 hours after it, comparing to the administration of fibrinogen up to an A10FIBTEM of 8mm.
Measured: Intraoperative and the first 24 hours after surgery.
Secondary outcomes (6)
Evaluation of the rate of other blood products between groups.
Demonstrate that the A10FIBTEM correction with the administration of fibrinogen up to an A10 FIBTEM value of 11mm change the administration of platelets, frozen fresh plasma and other blood products.
Measured: Intraoperative and the first 24 hours after surgery.
Evaluation of the acute kidney injury between groups using the Kidney Disease Improving Global Outcomes scale,the minimum values is 1 and the maximum values is 3, higher scores mean a worse outcome.
Demonstrate that the A10FIBTEM correction with the administration of fibrinogen up to an A10 FIBTEM value of 11mm change the kidney injury through study completion
Measured: first week after the procedure and until 90 days after the procedure.
Evaluation of the duration of mechanical ventilation in hours between groups.
Demonstrate that the A10FIBTEM correction with the administration of fibrinogen up to an A10 FIBTEM value of 11mm change the need of mechanical ventilation through study completion (comparing the number of hours of mechanical ventilation of each group).
Measured: first week after the procedure and until 90 days after the procedure..
Number of participants with major advers cardiac events (MACE), Number of participants with, any sign of infection, Number of participants with neurological events through study completion
Demonstrate that the A10FIBTEM correction with the administration of fibrinogen up to an A10 FIBTEM value of 11mm change the Number of participants with any adverse events.
Measured: Until 90 days after the procedure.
Number of participants with thrombotic events in the hepatic graft measured by ecodoppler assessment; and the number of participants with any other thrombotic events measured by ecodoppler assessment of leg extremity or tomography axial of the lungs
Demonstrate that the A10FIBTEM correction with the administration of fibrinogen up to an A10 FIBTEM value of 11mm do not change thrombotic events in the hepatic graft or in the patient.
Measured: Until 90 days after procedure
Number of participants who require reoperation for any cause; Number of participants who require being re transplanted and number of participant who died through the study completion
Demonstrate that the A10FIBTEM correction with the administration of fibrinogen up to an A10 FIBTEM value of 11mm do not change the outcome related to reoperation, re-transplantations or mortality.
Measured: Until 90 days after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start17 Jun 2019
- Primary completion2 Nov 2021
- Study completion31 Oct 2022 (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 Fibrin Blood ClotStudies 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
- Model description
- Participants will be randomly divided into a group receiving concentrate of fibrinogen in the different phases of the liver transplant procedure, to achieve * Thromboelastometry value (A10 FIBTEM) of 11mm (study group) or * Thromboelastometry value (A10 FIBTEM) of 8mm (control group) The doses of fibrinogen will be calculated acording to the formula based on previous study (AJT2017), rounded to the higher value according to the presentation format of the drug. Study medication will be stored at the hospital pharmacy.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antoni Sabaté Pes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Antoni Sabaté Pes, Hospital Universitari de Bellvitge
- Investigators
- Marta Caballero, Principal investigator, Hospital Universitari de BellvitgeJosep Beltran, Principal investigator, Clinic Hospital, BarcelonaRosa Gutierrez, Principal investigator, Cruces Hospital, Bilbao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04405518
- Sponsor's protocol ID
- TROMBOFIBtrial
- Other IDs
- 2018-002510-13, 2018
- Status last verified
- Nov 2021
- First submitted
- 10 Oct 2019
- Last updated
- 26 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sabate A, Caballero M, Gutierrez R, Perez L, Vidal J, Llaurado S, Hereu P, Penafiel J, Blasi A. Factors associated with major complications defined by Clavien-Dindo classification 3-5 after liver transplantation: a prospective multicenter cohort study. Front Surg. 2025 Nov 14;12:1648512. doi: 10.3389/fsurg.2025.1648512. eCollection 2025.
PubMed 41321850
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Two Thromboelastometry-guided Transfusion Strategies on Blood Product Requirements in Liver Transplantation. a Multicenter, Randomized Trial. TROMBOFIBtrial
- ClinicalTrials.gov ID
- NCT04405518
- Acronym / sponsor ID
- TROMBOFIBtrial
- Conditions
- Fibrin Blood Clot
- Keywords
- fibrinogen, red blood cell pack transfusion, orthotopic liver transplantation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Antoni Sabaté PesUniversity, hospital or other
- Study start
- 17 Jun 2019 (actual)
- Primary completion
- 2 Nov 2021 (actual)
- Study completion
- 31 Oct 2022 (estimated)
- First posted
- 28 May 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.
It is a national multicentre clinical study, where 3 hospitals are involved: Bellvitge University Hospital, Clinic Hospital of Barcelona and Cruces Hospital of Bilbao). It is a randomized study based on the Hemoglobin value of the patient with a 1:1 ratio, parallel groups, controlled and single blind, in patients undergoing an orthotopic liver transplant, confirming previously that the participants fulfill all the inclusion criteria and none of exclusion.
Detailed description
A total of 176 patients will be included (88 per group) and each center can not include more than 40% of the sample to avoid bias.
Blood samples will be analyzed at different times of the surgical intervention by an electronic device called thromboelastogram. It evaluates the blood clot characteristics and, depending on the results, assesses the need to correct values by the administration of fibrinogen or platelets.
One of the coagulation parameter evaluated and corrected by thromboelastogram is called A10FIBTEM. In a previous study, the investigators have seen that maintaining some specific ranges in the A10FIBTEM, results in a decrease of the use of blood products. That's why the investigators have created 2 groups:
- The control group will be corrected up to a value of A10FIBTEM = 8mm.
- The intervention group will be corrected up to a value of A10FIBTEM = 11mm.
Subsequently, results between groups will be compared. The investigators have to consider that the drug used in this study (Riastap) is an authorized and commercial drug.
The main objective is to demonstrate that the administration of fibrinogen in the intervention group compared to the control group changes the administration of red blood cells pack during the liver transplant and in the first 24 hours after.
Secondary objectives consist in demonstrate that in the intervention group, there is also a change in the administration of other blood products, a change in acute renal damage, a change in hours of mechanical ventilation, no changes in thrombotic events in the hepatic graft or in the patient in the first 90 days of the liver transplant and no changes in re operations, re-transplantation, or mortality during the first 90 days of the liver transplant, compared to the control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly divided into a group receiving concentrate of fibrinogen in the different phases of the liver transplant procedure, to achieve * Thromboelastometry value (A10 FIBTEM) of 11mm (study group) or * Thromboelastometry value (A10 FIBTEM) of 8mm (control group) The doses of fibrinogen will be calculated acording to the formula based on previous study (AJT2017), rounded to the higher value according to the presentation format of the drug. Study medication will be stored at the hospital pharmacy.
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Drug: Fibrinogen Concentrate (Human) 1 MG [RiaSTAP]The doses of fibrinogen will be calculated acording to the formula based on previous study (AJT2017), rounded to the higher value according to the presentation format of the drug. Study medication will be stored at the hospital pharmacy. Formula: 8mm - A10FIBTEM registered in mm) x 1.1 = fibrinogen dose required |
| intervention group | Experimental | Drug: Fibrinogen Concentrate (Human) 1 MG [RiaSTAP]The doses of fibrinogen will be calculated acording to the formula based on previous study (AJT2017), rounded to the higher value according to the presentation format of the drug. Study medication will be stored at the hospital pharmacy. Formula: 11mm - A10FIBTEM registered in mm) x 1.1 = fibrinogen dose required |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years.
- Candidate to an orthotopic liver trasnplantation.
- Informed consent.
- Preoperative hemoglobine </= 130 g/L
Key exclusion criteria (10 listed)
- Preoperative hemoglobin> 130 g / L
- Familial amyloid polyneuropathy
- Polycystosis hepatic
- Living donor liver transplant
- Uncontrolled donor after cardiac death
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 Concentrate (Human) 1 MG [RiaSTAP]The drug used in this study is Riastap, 1g (Fibrinogen). The dose administered will depend on the arm group assigned and in the results of the thromboelastogram during the procedure. | Drug | Control group, intervention group |
Primary outcome
Evaluation of the rate of red blood cell packs transfusion during procedure and in the first 24hours after between groups.
Time frame: Intraoperative and the first 24 hours after surgery.
Demonstrate that the A10FIBTEM correction with the administration of fibrinogen up to an A10FIBTEM value of 11mm, change the administration of red blood cell pack during the procedure and in the first 24 hours after it, comparing to the administration of fibrinogen up to an A10FIBTEM of 8mm.
6 secondary outcomes
Evaluation of the rate of other blood products between groups.
Time frame: Intraoperative and the first 24 hours after surgery.
Evaluation of the acute kidney injury between groups using the Kidney Disease Improving Global Outcomes scale,the minimum values is 1 and the maximum values is 3, higher scores mean a worse outcome.
Time frame: first week after the procedure and until 90 days after the procedure.
Evaluation of the duration of mechanical ventilation in hours between groups.
Time frame: first week after the procedure and until 90 days after the procedure..
Number of participants with major advers cardiac events (MACE), Number of participants with, any sign of infection, Number of participants with neurological events through study completion
Time frame: Until 90 days after the procedure.
Number of participants with thrombotic events in the hepatic graft measured by ecodoppler assessment; and the number of participants with any other thrombotic events measured by ecodoppler assessment of leg extremity or tomography axial of the lungs
Time frame: Until 90 days after procedure
Number of participants who require reoperation for any cause; Number of participants who require being re transplanted and number of participant who died through the study completion
Time frame: Until 90 days after procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2021.
- Derived from this study: PubMed 41321850Sabate A, Caballero M, Gutierrez R, Perez L, Vidal J, Llaurado S, Hereu P, Penafiel J, Blasi A. Factors associated with major complications defined by Clavien-Dindo classification 3-5 after liver transplantation: a prospective multicenter cohort study. Front Surg. 2025 Nov 14;12:1648512. doi: 10.3389/fsurg.2025.1648512. eCollection 2025.
- 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.
Marta Caballero principal investigator
Hospital Universitari de Bellvitge
Josep Beltran principal investigator
Clinic Hospital, Barcelona
Rosa Gutierrez principal investigator
Cruces Hospital, Bilbao
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fibrinogen Concentrate (Human) 1 MG [RiaSTAP] in people with Fibrin Blood Clot, run by Antoni Sabaté Pes at 3 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 4 inclusion and 10 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 26 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. 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?
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?
Evaluation of the rate of red blood cell packs transfusion during procedure and in the first 24hours after between groups. (time frame: Intraoperative and the first 24 hours after surgery.). 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 NCT04405518, 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 26 Nov 2021.