Fibrinogen Deficiency in Complex Cardiac SurgeryINDOFIBNCT07425600
Individualized Dose of Fibrinogen Following Cardiopulmonary Bypass
An observational study of Fibrinogen Deficiency in Complex Cardiac Surgery, run by Centre Hospitalier Universitaire de Saint Etienne at 2 sites in France.
Trial summary
Heart surgery is essential for many cardiovascular conditions, but it is a major operation with a significant mortality rate of around 4% in Europe. Among the main complications encountered postoperatively, hemorrhage occurs at a rate of around 8.2% for severe bleeding and 1.6% for massive bleeding. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibrinogen Deficiency in Complex Cardiac Surgery
- What is being tested?
- Blood samples for PK
- How many people
- 150 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Nov 2026to 7 Nov 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patient admitted for cardiac surgery and receiving fibrinogen administration after weaning from cardiopulmonary bypass
Who may be able to join
- Adult
- Patient undergoing cardiac surgery under cardiopulmonary bypass
- Indication for fibrinogen administration after cardiopulmonary bypass weaning
- Patient affiliated with or entitled to social security coverage
- Patient who has received informed consent about the study
Who cannot join
- Administration of fibrinogen in the context of massive transfusion
- Contraindication to the administration of the fibrinogen concentrate under study
- Constitutional afibrinogenemia, constitutional dysfibrinogenemia, or any other constitutional diseases related to hemostasis
- Pregnant women, women in labor, breastfeeding women
- Adults subject to legal protection measures (guardianship or curatorship)
- Patients with preoperative anemia < 6 g/dL
Show all 9Show fewer
- Patients with a life expectancy < 24 hours
- Patients who do not speak French
- Refusal to participate
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites
CHU de Lille
Lille, 59000
Mouhamed MOUSSA, MD, PhD, (0)320445322 ext. +33, mouhamed.moussa@chu-lille.fr
Julien TABAREAU-BEFFY, (0)362943576 ext. +33, julien.tabareau-beffy@chu-lille.fr
CHU de Saint-Etienne
Saint-Etienne, 42000
Julien LANOISELEE, MD, (0)477120388 ext. +33, julien.lanoiselee@chu-st-etienne.fr
Anaèle DESSAGNES, (0)477828556 ext. +33, anaele.dessagnes@chu-st-etienne.fr
About this study
Heart surgery is essential for many cardiovascular conditions, but it is a major operation with a significant mortality rate of around 4% in Europe. Among the main complications encountered postoperatively, hemorrhage occurs at a rate of around 8.2% for severe bleeding and 1.6% for massive bleeding.
Hemorrhagic complications are caused by hemostasis disorders attributable to extracorporeal circulation (ECC). Despite recent advances in material design, ECG activates hemostasis, leading to the consumption of various coagulation factors, including fibrinogen, as well as the absorption of fibrinogen by the various components of the circuit. Postoperative hypofibrinogenemia has multiple causes and is correlated with the risk of bleeding and the need for red blood cell transfusions in cardiac surgery under CPB, and therefore indirectly with mortality related to this procedure. The administration of fibrinogen concentrates is the standard treatment; however, the optimal dose to normalize fibrinogen levels and reduce bleeding is unknown.
Good practice recommendations in cardiac surgery suggest administering fibrinogen in cases of bleeding associated with fibrinogen levels below 2 g/L. However, the time required to obtain fibrinogen level results from the laboratory (approximately 1 hour) is not always compatible with the urgency of transfusion needs in these situations. Transfusion optimization strategies have been proposed using viscoelastic tests (ROTEM, Werfen, or Quantra, Stago, for example). The administration of fibrinogen guided by these tests has reduced the need for red blood cell transfusions; however, this strategy increases the cost attributable to fibrinogen because it favors its administration without individualizing the dose to be administered. To date, it is not possible to individualize the dose of fibrinogen to be administered based on baseline fibrinogen levels and kinetics. Developing such an administration strategy would allow for i) faster correction of hypofibrinogenemia and ii) a reduction in associated costs by administering the minimum effective dose.
- Being tested
- Blood samples for PK
- Keywords
- fibrinogen, cardiopulmonary bypass, pharmacokinetic modeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samples for PKBiological
Samples will be taken at regular intervals to characterize the kinetics of fibrinogen evolution post-transfusion. Sampling times will be at t = 0 (before transfusion), 10 minutes, H1, H3, H6, H9, H12, D1, and D2 relative to the start of fibrinogen transfusion (measurement of fibrinogen levels and viscoelastic tests), then every two days until the end of hospitalization (measurement of fibrinogen levels only).
| Study group | Role | What they receive |
|---|---|---|
| Patient receiving fibrinogen administration after weaning from cardiopulmonary bypass | Not described Receives: Biological: Blood samples for PK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterize the sources of variability in plasma fibrinogen levels in response to administration of fibrinogen concentrate after cardiac surgery with cardiopulmonary bypass.
Measurement of blood samples using the Clauss technique
Measured: During surgery (day 0) (before transfusion then at 10min, 1 hour, 3 hours, 6 hours, 9 hours, 12 hours after transfusion) then at day 1, day 2, day 4 and day 6.
Secondary outcomes (4)
Characterize the sources of variability in response to fibrinogen concentrate administration as assessed by the ROTEM viscoelastic test.
Measurement of blood samples using the ROTEM viscoelastic test
Measured: During surgery (day 0) (before transfusion then at 10min, 1 hour, 3 hours, 6 hours, 9 hours, 12 hours after transfusion) then at day 1 and day 2.
Characterize the sources of variability in response to fibrinogen concentrate administration as assessed by the Quantra viscoelastic test.
measurement of blood samples using the Quantra viscoelastic test
Measured: During surgery (day 0) (before transfusion then at 10min, 1 hour, 3 hours, 6 hours, 9 hours, 12 hours after transfusion) then at day 1 and day 2.
Characterize the correlation between fibrinogen exposure and postoperative bleeding after fibrinogen administration.
Blood loss in ml measured via surgical drains
Measured: During surgery (day 0) then at day 1 and day 2.
Study the relationship between different estimators of fibrinogen concentration.
Correlation coefficient between the different estimators of fibrinogen concentration and description using a Bland-Altman plot.
Measured: through study completion, an average of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Oct 2028 (estimated)
- Study completion7 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibrinogen Deficiency in Complex Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratoires LFB
- Responsible party
- Sponsor
- Investigators
- Julien LANOISELEE, MD, Principal investigator, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07425600
- Sponsor's protocol ID
- 23CH136
- Other IDs
- ANSM
- Acronym
- INDOFIB
- Status last verified
- Feb 2026
- First submitted
- 9 Feb 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Dose of Fibrinogen Following Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT07425600
- Acronym / sponsor ID
- INDOFIB / 23CH136
- Keywords
- fibrinogen, cardiopulmonary bypass, pharmacokinetic modeling
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Laboratoires LFB
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 7 Nov 2028 (estimated)
- First posted
- 23 Feb 2026 (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.
Heart surgery is essential for many cardiovascular conditions, but it is a major operation with a significant mortality rate of around 4% in Europe. Among the main complications encountered postoperatively, hemorrhage occurs at a rate of around 8.2% for severe bleeding and 1.6% for massive bleeding.
Hemorrhagic complications are caused by hemostasis disorders attributable to extracorporeal circulation (ECC). Despite recent advances in material design, ECG activates hemostasis, leading to the consumption of various coagulation factors, including fibrinogen, as well as the absorption of fibrinogen by the various components of the circuit. Postoperative hypofibrinogenemia has multiple causes and is correlated with the risk of bleeding and the need for red blood cell transfusions in cardiac surgery under CPB, and therefore indirectly with mortality related to this procedure. The administration of fibrinogen concentrates is the standard treatment; however, the optimal dose to normalize fibrinogen levels and reduce bleeding is unknown.
Good practice recommendations in cardiac surgery suggest administering fibrinogen in cases of bleeding associated with fibrinogen levels below 2 g/L. However, the time required to obtain fibrinogen level results from the laboratory (approximately 1 hour) is not always compatible with the urgency of transfusion needs in these situations. Transfusion optimization strategies have been proposed using viscoelastic tests (ROTEM, Werfen, or Quantra, Stago, for example). The administration of fibrinogen guided by these tests has reduced the need for red blood cell transfusions; however, this strategy increases the cost attributable to fibrinogen because it favors its administration without individualizing the dose to be administered. To date, it is not possible to individualize the dose of fibrinogen to be administered based on baseline fibrinogen levels and kinetics. Developing such an administration strategy would allow for i) faster correction of hypofibrinogenemia and ii) a reduction in associated costs by administering the minimum effective dose.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient receiving fibrinogen administration after weaning from cardiopulmonary bypass | – | Biological: Blood samples for PK |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient admitted for cardiac surgery and receiving fibrinogen administration after weaning from cardiopulmonary bypass
Key inclusion criteria (5 listed)
- Adult
- Patient undergoing cardiac surgery under cardiopulmonary bypass
- Indication for fibrinogen administration after cardiopulmonary bypass weaning
- Patient affiliated with or entitled to social security coverage
- Patient who has received informed consent about the study
Key exclusion criteria (9 listed)
- Administration of fibrinogen in the context of massive transfusion
- Contraindication to the administration of the fibrinogen concentrate under study
- Constitutional afibrinogenemia, constitutional dysfibrinogenemia, or any other constitutional diseases related to hemostasis
- Pregnant women, women in labor, breastfeeding women
- Adults subject to legal protection measures (guardianship or curatorship)
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 |
|---|---|---|
| Blood samples for PKSamples will be taken at regular intervals to characterize the kinetics of fibrinogen evolution post-transfusion. Sampling times will be at t = 0 (before transfusion), 10 minutes, H1, H3, H6, H9, H12, D1, and D2 relative to the start of fibrinogen transfusion (measurement of fibrinogen levels and viscoelastic tests), then every two days until the end of hospitalization (measurement of fibrinogen levels only). | Biological | Patient receiving fibrinogen administration after weaning from cardiopulmonary bypass |
Primary outcome
Characterize the sources of variability in plasma fibrinogen levels in response to administration of fibrinogen concentrate after cardiac surgery with cardiopulmonary bypass.
Time frame: During surgery (day 0) (before transfusion then at 10min, 1 hour, 3 hours, 6 hours, 9 hours, 12 hours after transfusion) then at day 1, day 2, day 4 and day 6.
Measurement of blood samples using the Clauss technique
4 secondary outcomes
Characterize the sources of variability in response to fibrinogen concentrate administration as assessed by the ROTEM viscoelastic test.
Time frame: During surgery (day 0) (before transfusion then at 10min, 1 hour, 3 hours, 6 hours, 9 hours, 12 hours after transfusion) then at day 1 and day 2.
Characterize the sources of variability in response to fibrinogen concentrate administration as assessed by the Quantra viscoelastic test.
Time frame: During surgery (day 0) (before transfusion then at 10min, 1 hour, 3 hours, 6 hours, 9 hours, 12 hours after transfusion) then at day 1 and day 2.
Characterize the correlation between fibrinogen exposure and postoperative bleeding after fibrinogen administration.
Time frame: During surgery (day 0) then at day 1 and day 2.
Study the relationship between different estimators of fibrinogen concentration.
Time frame: through study completion, an average of 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
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.
Julien LANOISELEE, MD principal investigator
CHU de Saint-Etienne
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibrinogen Deficiency in Complex Cardiac Surgery, run by Centre Hospitalier Universitaire de Saint Etienne at 2 sites 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 5 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: opening soon, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julien LANOISELEE, MD ((0)477120388 ext. +33, julien.lanoiselee@chu-st-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterize the sources of variability in plasma fibrinogen levels in response to administration of fibrinogen concentrate after cardiac surgery with cardiopulmonary bypass. (time frame: During surgery (day 0) (before transfusion then at 10min, 1 hour, 3 hours, 6 hours, 9 hours, 12 hours after transfusion) then at day 1, day 2, day 4 and day 6.). 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 22 Apr 2026.