Fibrinogen Concentrate In Children After Cardiac Surgery (FiCCS)

Fibrinogen Concentrate to Treat Bleeding in Children Undergoing Cardiac Surgery With Pump: a Randomised Controlled Clinical Trial

The purpose of this study is to evaluate prospectively whether concentrate fibrinogen reduces blood losses, transfusion requirements and occurrence of clinical complications compared to cryoprecipitate in children after cardiac surgery with pump.

Study Overview

• Status: Completed
• Conditions: Blood Coagulation Disorders; Cardiac Surgical Procedures; Fibrinogen; Cryoprecipitate
• Intervention / Treatment: Drug: Fibrinogen concentrate; Drug: Cryoprecipitate

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. In most centre world-wide, it is common practice to treat bleeding in these patients with cryoprecipitate in order to substitute fibrinogen. Fibrinogen concentrate (Haemocomplettan P)may reduce perioperative bleeding, requirements of blood transfusion and clinical outcomes in children undergoing cardiac surgery with pump, compared to cryoprecipitate.

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Phase 2

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Sao Paulo, SP, Brazil, 05403000
      • Incor - Heart Institute - University of Sao Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Cardiac surgery with pump
• Age until 18 years
• Written informed consent
• Clinically important bleeding in intraoperative
• Fibrinogen lower than 1 g/L or TEG < 7 mm

Exclusion Criteria:

• Previous coagulopathy (clinical history or INR > 1.5)
• Low platelet count (lower than 100.000)
• Product allergy
• Urgent procedures
• Active infection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fibrinogen concentrate	Drug: Fibrinogen concentrate; In this arm, children (< 18 year-old)undergoing cardiac surgery with pump will receive fibrinogen concentrate (60 mg/Kg) if they present clinically significant bleeding associated to low levels of fibrinogen (< 1g/L) or TEG < 7 mm; Other Names: Haemocompletan
Active Comparator: Cryoprecipitate	Drug: Cryoprecipitate; In this arm, children (< 18 year-old)undergoing cardiac surgery with pump will receive cryoprecipiate (10 ml/Kg) if they present clinically significant bleeding associated to low levels of fibrinogen (< 1g/L) or TEG < 7 mm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients receiving any allogeneic blood products	Percentage of patients exposed to allogeneic blood products (red blood cells, FFP, platelet concentrate and cryoprecipitate) after ICU admission until hospital discharge.	From ICU admission until hospital discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of ICU stay	Length of ICU stay - days since arrival at ICU until discharge	Up to ICU discharge
Clinical complications - renal failure, respiratory failure,sepsis, myocardial ischemia, stroke	Clinical complications since intraoperative until hospital discharge	Up to hospital discharge
Mechanical ventilation free-days	Number of days without mechanical ventilation during ICU stay	Up to ICU discharge
Length of hospital stay	Number of days since arrival at ICU until hospital discharge	Up to hospital discharge
Vasopressors free-days	Number of days without vasopressors during ICU stay	Up to ICU discharge
intraoperative transfusion	intraoperative requirements of any blood product (red blood cells, FFP, platelet concentrate and cryoprecipitate))	intraoperative period
postoperative blood losses	postoperative blood losses determined by the weight of dressings at intraoperative and chest tube drainage 12h and 24h after ICU admission	from ICU admission until hospital discharge

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Collaborators: CSL Behring

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: August 17, 2010
• First Submitted That Met QC Criteria: August 23, 2010
• First Posted (Estimate): August 24, 2010

Study Record Updates

• Last Update Posted (Estimate): January 4, 2013
• Last Update Submitted That Met QC Criteria: January 2, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Bleeding; Fibrinogen; Cryoprecipitate; Cardiac surgical procedures
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Blood Coagulation Disorders
• Other Study ID Numbers: 0930/09