Fibrinogen Concentrate In Children Cardiac Surgery 2

Phase 4

• Conditions: C.Surgical Procedure; Cardiac; Blood Coagulation Disorders; Hypofibrinogenemia
• Interventions: Other: control; Drug: Fibrinogen Concentrate

• Registration Number: NCT03884725
• Lead Sponsor: Filomena R B G Galas

Brief Summary

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 Timeline

• Status Verified: 2019-03
• Study Start: 2019-03-01
• Study First Submitted: 2019-03-18
• Study First Submitted QC: 2019-03-20
• Last Update Submitted: 2019-03-20
• Study First Posted: 2019-03-21
• Last Update Posted: 2019-03-21
• Primary Completion: 2019-06
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 42

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	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)
fibrinogen concentrate	Fibrinogen Concentrate	patients randomized to fibrinogen group receive intravenous infusion of drug prepared based on ROTEM measurement of maximum clot firmness (MCF)

Primary Outcome Measures

Name	Time	Method
The amount of postoperative bleeding	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

Name	Time	Method
The amount and type of blood transfusion	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 mortality	within 28 days after cardiac surgery	Death from all causes occurring up to 28 days after surgery.
Evaluation of the clot firmness before and after the intervention	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
Correlation between clot firmness (FIBTEM) and plasma fibrinogen	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 plasma fibrinogen before and after the intervention	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.
Length of ICU stay	within 28 days after cardiac surgery	number of days between the admission and discharge from the ICU.
Rate of infection complications	within 28 days after cardiac surgery	Infection (surgical wound infection, pneumonia, urinary tract infection and bloodstream infection), sepsis, severe sepsis and septic shock.
Rate of acute kidney injury	within 28 days after cardiac surgery	According to pediatric RIFLE, will be measured daily.
Rate of cardiac complications	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	within 28 days after cardiac surgery	Incidence of stroke
Duration of mechanical ventilation	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	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 hospital stay	within 28 days after cardiac surgery	number of days between the date of surgery and hospital discharge.

Trial Locations

Locations (1)

Incor - Heart Institute - University of Sao Paulo; 🇧🇷 Sao Paulo, Brazil