C.Surgical Procedure; CardiacPhase 4FiCCS2NCT03884725
Fibrinogen Concentrate In Children Cardiac Surgery 2
A Phase 4 study testing Fibrinogen Concentrate in people with C.Surgical Procedure; Cardiac and Blood Coagulation Disorders, run by Filomena R B G Galas at 1 site in Brazil.
Trial summary
The purporse of this study is evaluate whether fibrinogen concentrate reduces postoperative bleeding in pediatric cardiac surgery with cardiopulmonary by-pass. Read more about this study
- Who is it for?
- Ages Up to 10 years
- Conditions the study is for
- C.Surgical Procedure; Cardiac, Blood Coagulation Disorders, Hypofibrinogenemia
- What is being tested?
- Fibrinogen Concentrate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Mar 2019to Jun 2019
- 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 Up to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Cardiac surgery with pump
- Written informed consent
- Age under 28 days of life or RACHS-1 equal or greater than 3 or reoperation with age under 10 years
Who cannot join
- Coagulopathy (INR > 1.5)
- Low platelet count (lower than 100.000)
- Product or albumin allergy
- Active endocarditis
- Blalock-Taussig
- Heart transplant
Show all 12Show fewer
- Anemia (hemoglobin < 10 g/dL)
- Impossibility to receive blood transfusion
- Hepatic dysfunction (total bilirubin > 1.5 mg/dL)
- Known or suspected hypersensitivity to fibrinogen concentrate
- Thrombophilia or previous thrombosis
- Participation in another study
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Incor - Heart Institute - University of Sao Paulo
São Paulo, 05403000
Filomena RG Galas, +551126615232, filomenagalas@hotmail.com
About this study
Official title: Profilatic Fibrinogen Concentrate Reduces Postoperative Bleeding in Pediatric Cardiac Surgery With Cardiopulmonary Bypass: Randomized Study
The purporse of this study is evaluate whether fibrinogen concentrate reduces postoperative bleeding in pediatric cardiac surgery with cardiopulmonary by-pass.
Read the detailed description
Cardiac surgery in children may be associated with excessive perioperative bleeding. Perioperative excessive bleeding is associated with need of transfusion with allogeneic blood products such as red blood cells, fresh frozen plasma, platelet pools, and cryoprecipitate. Furthermore, bleeding may result in re-exploration, which is associated with increased morbidity and mortality.Recent studies have shown that patients and children undergoing cardiac surgery with pump often experience a significant drop in their levels and function of fibrinogen, and it would be in part responsible for the bleeding. Fibrinogen concentrate (Haemocomplettan P)may reduce perioperative bleeding, requirements of blood transfusion and clinical outcomes in children undergoing cardiac surgery with pump.
- Being tested
- Fibrinogen Concentrate, control
- Keywords
- Cardiac surgical procedures, Fibrinogen, Bleeding
- Medical subject headings
- Blood Coagulation Disorders, Afibrinogenemia, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibrinogen ConcentrateDrug
Fibrinogen Concentrate is to be administered as an intravenous infusion after discontinuation of cardiopulmonary bypass and administration of protamine. Subjects are to be given Fibrinogen Concentrate at an individually determined dose based on FIBTEM MCF and body weight as follows: (15 [mm] - MCF [mm]) * body weight [kg] / 140 [mm*kg/g] = gram fibrinogen to be dosed as Fibrinogen Concentrate. Fibrinogen Concentrate is to be infused over 1 to 2 minutes. After Fibrinogen Concentrate infusion, bleeding treatment will follow the predefined, standardized treatment regimen.
controlOther
0.9% saline is to be administered as an intravenous infusion after discontinuation of cardiopulmonary bypass and administration of protamine. Patients randomized to the control group will receive the infusion of 0.9% saline (SF0,9%) prepared based on ROTEM measurement of maximum clot firmness (MCF). 0.9% saline is to be infused over 1 to 2 minutes. After 0.9% saline infusion, bleeding treatment will follow the predefined, standardized treatment regimen.
| Study group | Role | What they receive |
|---|---|---|
| fibrinogen concentrate | Active comparator | patients randomized to fibrinogen group receive intravenous infusion of drug prepared based on ROTEM measurement of maximum clot firmness (MCF) Receives: Drug: Fibrinogen Concentrate |
| control | Placebo comparator | patients randomized to the control group will receive the infusion of 0.9% saline (SF0,9%) prepared based on ROTEM measurement of maximum clot firmness (MCF) Receives: Other: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
The amount of postoperative bleeding
The amount of blood loss (tube drainage) in the first 6 hours of ICU admission and daily until the seventh day of ICU. Re-exploration is mandatory if the patient presente excessive bleeding not responsive to clinical measures (warming, coagulopathy correction and/or thrombocytopenia correction), associated hemodynamic instability or evidence of cardiac tamponade.
Measured: Within 7 days after cardiac surgery
Secondary outcomes (13)
The amount and type of blood transfusion
The amount and type of intraoperative blood transfusion within the first 6 hours of ICU admission and daily up to the seventh day of ICU.
Measured: within 7 days after cardiac surgery
Rate of acute kidney injury
According to pediatric RIFLE, will be measured daily.
Measured: within 28 days after cardiac surgery
Rate of cardiac complications
Occurrence of arrhythmias, low cardiac output, cardiogenic shock and the need of postoperative ventricular assistance
Measured: within 28 days after cardiac surgery
Rate of neurological complications
Incidence of stroke
Measured: within 28 days after cardiac surgery
Rate of infection complications
Infection (surgical wound infection, pneumonia, urinary tract infection and bloodstream infection), sepsis, severe sepsis and septic shock.
Measured: within 28 days after cardiac surgery
Correlation between clot firmness (FIBTEM) and plasma fibrinogen
Relationship among the results of FIBTEM-A10 and plasma fibrinogen level will be performed at the same time
Measured: After the cardiopulmonary bypass (CPB) weaning and after drug administration during the surgery.
Evaluation of the clot firmness before and after the intervention
Evaluation between FIBTEM-A10 that will be measured after the cardiopulmonary bypass (CPB) weaning and after drug intervention
Measured: After the cardiopulmonary bypass (CPB) weaning and after drug administration during the surgery.
Evaluation of plasma fibrinogen before and after the intervention
Evaluation between the fibrinogen level that will be measured after the cardiopulmonary bypass (CPB) weaning, after drug intervention and in the ICU admission.
Measured: After the cardiopulmonary bypass (CPB) weaning, after drug administration during the surgery and in ICU admission.
Duration of mechanical ventilation
number of hours in which the patient reiman intubated between the date of surgery and discharge from the ICU
Measured: within 28 days after cardiac surgery
Length of vasoactive drugs
number of hours in which the patient will use vasoactive drugs between the date of surgery and discharge from the ICU
Measured: within 28 days after cardiac surgery
Length of ICU stay
number of days between the admission and discharge from the ICU.
Measured: within 28 days after cardiac surgery
Length of hospital stay
number of days between the date of surgery and hospital discharge.
Measured: within 28 days after cardiac surgery
Rate of mortality
Death from all causes occurring up to 28 days after surgery.
Measured: within 28 days after cardiac surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start1 Mar 2019
- Primary completionJun 2019 (estimated)
- Study completionJun 2019 (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 C.Surgical Procedure; CardiacStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Filomena R B G Galas
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Filomena R B G Galas, Instituto do Coracao
- Investigators
- Filomena RG Galas, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03884725
- Sponsor's protocol ID
- 3864.12.120
- Acronym
- FiCCS2
- Status last verified
- Mar 2019
- First submitted
- 18 Mar 2019
- Last updated
- 21 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Galas FR, de Almeida JP, Fukushima JT, Vincent JL, Osawa EA, Zeferino S, Camara L, Guimaraes VA, Jatene MB, Hajjar LA. Hemostatic effects of fibrinogen concentrate compared with cryoprecipitate in children after cardiac surgery: a randomized pilot trial. J Thorac Cardiovasc Surg. 2014 Oct;148(4):1647-55. doi: 10.1016/j.jtcvs.2014.04.029. Epub 2014 Apr 18.
PubMed 24951020
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Profilatic Fibrinogen Concentrate Reduces Postoperative Bleeding in Pediatric Cardiac Surgery With Cardiopulmonary Bypass: Randomized Study
- ClinicalTrials.gov ID
- NCT03884725
- Acronym / sponsor ID
- FiCCS2 / 3864.12.120
- Keywords
- Cardiac surgical procedures, Fibrinogen, Bleeding
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Filomena R B G GalasOther government
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 21 Mar 2019 (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.
The purporse of this study is evaluate whether fibrinogen concentrate reduces postoperative bleeding in pediatric cardiac surgery with cardiopulmonary by-pass.
Detailed description
Cardiac surgery in children may be associated with excessive perioperative bleeding. Perioperative excessive bleeding is associated with need of transfusion with allogeneic blood products such as red blood cells, fresh frozen plasma, platelet pools, and cryoprecipitate. Furthermore, bleeding may result in re-exploration, which is associated with increased morbidity and mortality.Recent studies have shown that patients and children undergoing cardiac surgery with pump often experience a significant drop in their levels and function of fibrinogen, and it would be in part responsible for the bleeding. Fibrinogen concentrate (Haemocomplettan P)may reduce perioperative bleeding, requirements of blood transfusion and clinical outcomes in children undergoing cardiac surgery with pump.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fibrinogen concentrate | Active comparator | Drug: Fibrinogen Concentratepatients randomized to fibrinogen group receive intravenous infusion of drug prepared based on ROTEM measurement of maximum clot firmness (MCF) |
| control | Placebo comparator | Other: controlpatients randomized to the control group will receive the infusion of 0.9% saline (SF0,9%) prepared based on ROTEM measurement of maximum clot firmness (MCF) |
Who may qualify
- Ages
- Up to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Cardiac surgery with pump
- Written informed consent
- Age under 28 days of life or RACHS-1 equal or greater than 3 or reoperation with age under 10 years
Key exclusion criteria (12 listed)
- Coagulopathy (INR > 1.5)
- Low platelet count (lower than 100.000)
- Product or albumin allergy
- Active endocarditis
- Blalock-Taussig
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 ConcentrateFibrinogen Concentrate is to be administered as an intravenous infusion after discontinuation of cardiopulmonary bypass and administration of protamine. Subjects are to be given Fibrinogen Concentrate at an individually determined dose based on FIBTEM MCF and body weight as follows: (15 [mm] - MCF [mm]) * body weight [kg] / 140 [mm*kg/g] = gram fibrinogen to be dosed as Fibrinogen Concentrate. Fibrinogen Concentrate is to be infused over 1 to 2 minutes. After Fibrinogen Concentrate infusion, bleeding treatment will follow the predefined, standardized treatment regimen. | Drug | fibrinogen concentrate |
| control0.9% saline is to be administered as an intravenous infusion after discontinuation of cardiopulmonary bypass and administration of protamine. Patients randomized to the control group will receive the infusion of 0.9% saline (SF0,9%) prepared based on ROTEM measurement of maximum clot firmness (MCF). 0.9% saline is to be infused over 1 to 2 minutes. After 0.9% saline infusion, bleeding treatment will follow the predefined, standardized treatment regimen. | Other | control |
Primary outcome
The amount of postoperative bleeding
Time frame: Within 7 days after cardiac surgery
The amount of blood loss (tube drainage) in the first 6 hours of ICU admission and daily until the seventh day of ICU. Re-exploration is mandatory if the patient presente excessive bleeding not responsive to clinical measures (warming, coagulopathy correction and/or thrombocytopenia correction), associated hemodynamic instability or evidence of cardiac tamponade.
13 secondary outcomes
The amount and type of blood transfusion
Time frame: within 7 days after cardiac surgery
Rate of acute kidney injury
Time frame: within 28 days after cardiac surgery
Rate of cardiac complications
Time frame: within 28 days after cardiac surgery
Rate of neurological complications
Time frame: within 28 days after cardiac surgery
Rate of infection complications
Time frame: within 28 days after cardiac surgery
Correlation between clot firmness (FIBTEM) and plasma fibrinogen
Time frame: After the cardiopulmonary bypass (CPB) weaning and after drug administration during the surgery.
Evaluation of the clot firmness before and after the intervention
Time frame: After the cardiopulmonary bypass (CPB) weaning and after drug administration during the surgery.
Evaluation of plasma fibrinogen before and after the intervention
Time frame: After the cardiopulmonary bypass (CPB) weaning, after drug administration during the surgery and in ICU admission.
Duration of mechanical ventilation
Time frame: within 28 days after cardiac surgery
Length of vasoactive drugs
Time frame: within 28 days after cardiac surgery
Length of ICU stay
Time frame: within 28 days after cardiac surgery
Length of hospital stay
Time frame: within 28 days after cardiac surgery
Rate of mortality
Time frame: within 28 days after cardiac surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2019.
- Results publication: PubMed 24951020Galas FR, de Almeida JP, Fukushima JT, Vincent JL, Osawa EA, Zeferino S, Camara L, Guimaraes VA, Jatene MB, Hajjar LA. Hemostatic effects of fibrinogen concentrate compared with cryoprecipitate in children after cardiac surgery: a randomized pilot trial. J Thorac Cardiovasc Surg. 2014 Oct;148(4):1647-55. doi: 10.1016/j.jtcvs.2014.04.029. Epub 2014 Apr 18.
- Bleeding, Bleeding Disorders, Heart SurgeryLink provided by the sponsor.
- Fibrinogen ConcentrateLink provided by the sponsor.
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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.
Filomena RG Galas principal investigator
University of Sao Paulo
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 Fibrinogen Concentrate in people with C.Surgical Procedure; Cardiac and Blood Coagulation Disorders, run by Filomena R B G Galas at 1 site in Brazil.
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 3 inclusion and 12 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 21 Mar 2019. 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 Brazil. 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 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?
Contact Filomena RG Galas (+551126615232, filomenagalas@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The amount of postoperative bleeding (time frame: Within 7 days after cardiac 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 NCT03884725, 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 21 Mar 2019.