Fibrinogen Concentrate In Children Cardiac Surgery 2 (FiCCS2)
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ClinicalTrials.gov Identifier: NCT03884725 |
Recruitment Status :
Recruiting
First Posted : March 21, 2019
Last Update Posted : March 21, 2019
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Condition or disease | Intervention/treatment | Phase |
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C.Surgical Procedure; Cardiac Blood Coagulation Disorders Hypofibrinogenemia | Drug: Fibrinogen Concentrate Other: control | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 42 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Prevention |
Official Title: | Profilatic Fibrinogen Concentrate Reduces Postoperative Bleeding in Pediatric Cardiac Surgery With Cardiopulmonary Bypass: Randomized Study |
Actual Study Start Date : | March 1, 2019 |
Estimated Primary Completion Date : | June 2019 |
Estimated Study Completion Date : | June 2019 |

Arm | Intervention/treatment |
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Active Comparator: fibrinogen concentrate
patients randomized to fibrinogen group receive intravenous infusion of drug prepared based on ROTEM measurement of maximum clot firmness (MCF)
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Drug: Fibrinogen Concentrate
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. |
Placebo Comparator: control
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)
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Other: control
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. |
- 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.
- The amount and type of blood transfusion [ Time Frame: within 7 days after cardiac surgery ]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.
- Rate of acute kidney injury [ Time Frame: within 28 days after cardiac surgery ]According to pediatric RIFLE, will be measured daily.
- Rate of cardiac complications [ Time Frame: within 28 days after cardiac surgery ]Occurrence of arrhythmias, low cardiac output, cardiogenic shock and the need of postoperative ventricular assistance
- Rate of neurological complications [ Time Frame: within 28 days after cardiac surgery ]Incidence of stroke
- Rate of infection complications [ Time Frame: within 28 days after cardiac surgery ]Infection (surgical wound infection, pneumonia, urinary tract infection and bloodstream infection), sepsis, severe sepsis and septic shock.
- Correlation between clot firmness (FIBTEM) and plasma fibrinogen [ Time Frame: After the cardiopulmonary bypass (CPB) weaning and after drug administration during the surgery. ]Relationship among the results of FIBTEM-A10 and plasma fibrinogen level will be performed at the same time
- 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 between FIBTEM-A10 that will be measured after the cardiopulmonary bypass (CPB) weaning and after drug intervention
- 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. ]Evaluation between the fibrinogen level that will be measured after the cardiopulmonary bypass (CPB) weaning, after drug intervention and in the ICU admission.
- Duration of mechanical ventilation [ Time Frame: within 28 days after cardiac surgery ]number of hours in which the patient reiman intubated between the date of surgery and discharge from the ICU
- Length of vasoactive drugs [ Time Frame: within 28 days after cardiac surgery ]number of hours in which the patient will use vasoactive drugs between the date of surgery and discharge from the ICU
- Length of ICU stay [ Time Frame: within 28 days after cardiac surgery ]number of days between the admission and discharge from the ICU.
- Length of hospital stay [ Time Frame: within 28 days after cardiac surgery ]number of days between the date of surgery and hospital discharge.
- Rate of mortality [ Time Frame: within 28 days after cardiac surgery ]Death from all causes occurring up to 28 days after surgery.

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Ages Eligible for Study: | up to 10 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- Coagulopathy (INR > 1.5)
- Low platelet count (lower than 100.000)
- Product or albumin allergy
- Active endocarditis
- Blalock-Taussig
- Heart transplant
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03884725
Contact: Filomena RG Galas | +551126615232 | filomenagalas@hotmail.com |
Brazil | |
Incor - Heart Institute - University of Sao Paulo | Recruiting |
Sao Paulo, Brazil, 05403000 | |
Contact: Filomena RG Galas +551126615232 filomenagalas@hotmail.com |
Principal Investigator: | Filomena RG Galas | University of Sao Paulo |
Publications of Results:
Responsible Party: | Filomena R B G Galas, Associate Professor of Anesthesiology at University São Paulo Medical School, Instituto do Coracao |
ClinicalTrials.gov Identifier: | NCT03884725 |
Other Study ID Numbers: |
3864.12.120 |
First Posted: | March 21, 2019 Key Record Dates |
Last Update Posted: | March 21, 2019 |
Last Verified: | March 2019 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Cardiac surgical procedures Fibrinogen Bleeding |
Hemostatic Disorders Blood Coagulation Disorders Hematologic Diseases |
Vascular Diseases Cardiovascular Diseases Hemorrhagic Disorders |