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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03884725
Other study ID # 3864.12.120
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date March 1, 2019
Est. completion date June 2019

Study information

Verified date March 2019
Source Instituto do Coracao
Contact Filomena RG Galas
Phone +551126615232
Email filomenagalas@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 42
Est. completion date June 2019
Est. primary completion date June 2019
Accepts healthy volunteers No
Gender All
Age group N/A to 10 Years
Eligibility 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

Study Design


Intervention

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.
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.

Locations

Country Name City State
Brazil Incor - Heart Institute - University of Sao Paulo Sao Paulo

Sponsors (1)

Lead Sponsor Collaborator
Filomena R B G Galas

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

Galas FR, de Almeida JP, Fukushima JT, Vincent JL, Osawa EA, Zeferino S, Câmara L, Guimarães VA, Jatene MB, Hajjar LA. Hemostatic effects of fibrinogen concentrate compared with cryoprecipitate in children after cardiac surgery: a randomized pilot trial. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Within 7 days after cardiac surgery
Secondary 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. within 7 days after cardiac surgery
Secondary Rate of acute kidney injury According to pediatric RIFLE, will be measured daily. within 28 days after cardiac surgery
Secondary Rate of cardiac complications Occurrence of arrhythmias, low cardiac output, cardiogenic shock and the need of postoperative ventricular assistance within 28 days after cardiac surgery
Secondary Rate of neurological complications Incidence of stroke within 28 days after cardiac surgery
Secondary Rate of infection complications Infection (surgical wound infection, pneumonia, urinary tract infection and bloodstream infection), sepsis, severe sepsis and septic shock. within 28 days after cardiac surgery
Secondary 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 After the cardiopulmonary bypass (CPB) weaning and after drug administration during the surgery.
Secondary 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 After the cardiopulmonary bypass (CPB) weaning and after drug administration during the surgery.
Secondary 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. After the cardiopulmonary bypass (CPB) weaning, after drug administration during the surgery and in ICU admission.
Secondary Duration of mechanical ventilation number of hours in which the patient reiman intubated between the date of surgery and discharge from the ICU within 28 days after cardiac surgery
Secondary 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 within 28 days after cardiac surgery
Secondary Length of ICU stay number of days between the admission and discharge from the ICU. within 28 days after cardiac surgery
Secondary Length of hospital stay number of days between the date of surgery and hospital discharge. within 28 days after cardiac surgery
Secondary Rate of mortality Death from all causes occurring up to 28 days after surgery. within 28 days after cardiac surgery
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