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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
Sponsor:
Information provided by (Responsible Party):
Filomena R B G Galas, Instituto do Coracao

Study Description
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Brief Summary:
The purporse of this study is evaluate whether fibrinogen concentrate reduces postoperative bleeding in pediatric cardiac surgery with cardiopulmonary by-pass.

Condition or disease Intervention/treatment Phase
C.Surgical Procedure; Cardiac Blood Coagulation Disorders Hypofibrinogenemia Drug: Fibrinogen Concentrate Other: control Phase 4

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
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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

Resource links provided by the National Library of Medicine

Drug Information available for: Fibrinogen

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: fibrinogen concentrate
patients randomized to fibrinogen group receive intravenous infusion of drug prepared based on ROTEM measurement of maximum clot firmness (MCF)
 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)
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Rate of acute kidney injury [ Time Frame: within 28 days after cardiac surgery ]
    According to pediatric RIFLE, will be measured daily.

  3. 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

  4. Rate of neurological complications [ Time Frame: within 28 days after cardiac surgery ]
    Incidence of stroke

  5. 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.

  6. 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

  7. 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

  8. 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.

  9. 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

  10. 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

  11. Length of ICU stay [ Time Frame: within 28 days after cardiac surgery ]
    number of days between the admission and discharge from the ICU.

  12. Length of hospital stay [ Time Frame: within 28 days after cardiac surgery ]
    number of days between the date of surgery and hospital discharge.

  13. Rate of mortality [ Time Frame: within 28 days after cardiac surgery ]
    Death from all causes occurring up to 28 days after surgery.


Eligibility Criteria
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Ages Eligible for Study:   up to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Filomena RG Galas +551126615232 filomenagalas@hotmail.com

Locations
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Brazil
Incor - Heart Institute - University of Sao Paulo Recruiting
Sao Paulo, Brazil, 05403000
Contact: Filomena RG Galas    +551126615232    filomenagalas@hotmail.com   
Sponsors and Collaborators
Filomena R B G Galas
Investigators
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Principal Investigator: Filomena RG Galas University of Sao Paulo
More Information
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Additional Information:

Publications of Results:

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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Filomena R B G Galas, Instituto do Coracao:
Cardiac surgical procedures
Fibrinogen
Bleeding
Additional relevant MeSH terms:
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Hemostatic Disorders
Blood Coagulation Disorders
Hematologic Diseases
 Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders