Fibrinogen Concentrate In Children After Cardiac Surgery

Cardiac Surgical Procedures Clinical Trial

— FiCCS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01187225
• Other study ID #: 0930/09
• Status: Completed
• Phase: Phase 2
• First received: August 17, 2010
• Last updated: January 2, 2013
• Start date: August 2010
• Est. completion date: November 2011

Study information

• Verified date: January 2013
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: November 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Cardiac Surgical Procedures
• Cryoprecipitate
• Fibrinogen
• Hemostatic Disorders

Intervention

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
• 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

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	CSL Behring

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Length of ICU stay	Length of ICU stay - days since arrival at ICU until discharge	Up to ICU discharge	Yes
Secondary	Clinical complications - renal failure, respiratory failure,sepsis, myocardial ischemia, stroke	Clinical complications since intraoperative until hospital discharge	Up to hospital discharge	Yes
Secondary	Mechanical ventilation free-days	Number of days without mechanical ventilation during ICU stay	Up to ICU discharge	Yes
Secondary	Length of hospital stay	Number of days since arrival at ICU until hospital discharge	Up to hospital discharge	No
Secondary	Vasopressors free-days	Number of days without vasopressors during ICU stay	Up to ICU discharge	No
Secondary	intraoperative transfusion	intraoperative requirements of any blood product (red blood cells, FFP, platelet concentrate and cryoprecipitate))	intraoperative period	Yes
Secondary	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	Yes