Fibrinogen Concentrate In Children After Cardiac Surgery - Full Text View

Purpose

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.

Condition	Intervention	Phase
Cardiac Surgical Procedures Blood Coagulation Disorders Fibrinogen Cryoprecipitate	Drug: Fibrinogen concentrate Drug: Cryoprecipitate	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Fibrinogen Concentrate to Treat Bleeding in Children Undergoing Cardiac Surgery With Pump: a Randomised Controlled Clinical Trial

Resource links provided by NLM:

MedlinePlus related topics: Bleeding Disorders Heart Surgery

Drug Information available for: Fibrinogen

U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:

Number of patients receiving any allogeneic blood products [ Time Frame: From ICU admission until hospital discharge ] [ Designated as safety issue: Yes ]
Percentage of patients exposed to allogeneic blood products (red blood cells, FFP, platelet concentrate and cryoprecipitate) after ICU admission until hospital discharge.

Secondary Outcome Measures:

Length of ICU stay [ Time Frame: Up to ICU discharge ] [ Designated as safety issue: Yes ]
Length of ICU stay - days since arrival at ICU until discharge
Clinical complications - renal failure, respiratory failure,sepsis, myocardial ischemia, stroke [ Time Frame: Up to hospital discharge ] [ Designated as safety issue: Yes ]
Clinical complications since intraoperative until hospital discharge
Mechanical ventilation free-days [ Time Frame: Up to ICU discharge ] [ Designated as safety issue: Yes ]
Number of days without mechanical ventilation during ICU stay
Length of hospital stay [ Time Frame: Up to hospital discharge ] [ Designated as safety issue: No ]
Number of days since arrival at ICU until hospital discharge
Vasopressors free-days [ Time Frame: Up to ICU discharge ] [ Designated as safety issue: No ]
Number of days without vasopressors during ICU stay
intraoperative transfusion [ Time Frame: intraoperative period ] [ Designated as safety issue: Yes ]
intraoperative requirements of any blood product (red blood cells, FFP, platelet concentrate and cryoprecipitate))
postoperative blood losses [ Time Frame: from ICU admission until hospital discharge ] [ Designated as safety issue: Yes ]
postoperative blood losses determined by the weight of dressings at intraoperative and chest tube drainage 12h and 24h after ICU admission

Enrollment:	63
Study Start Date:	August 2010
Study Completion Date:	November 2011
Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: 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

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.

Eligibility

Ages Eligible for Study:	up to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01187225

Locations

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

Sponsors and Collaborators

University of Sao Paulo

CSL Behring

More Information

No publications provided

Responsible Party:	Ludhmila Abrahão Hajjar, Principal Investigator, University of Sao Paulo
ClinicalTrials.gov Identifier:	NCT01187225 History of Changes
Other Study ID Numbers:	0930/09
Study First Received:	August 17, 2010
Last Updated:	January 2, 2013
Health Authority:	Brazil: Ethics Committee

Keywords provided by University of Sao Paulo:

Cardiac surgical procedures
Fibrinogen
Bleeding
Cryoprecipitate

Additional relevant MeSH terms:

Blood Coagulation Disorders
Hemostatic Disorders
Hematologic Diseases

Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders

ClinicalTrials.gov processed this record on May 23, 2013

Fibrinogen Concentrate In Children After Cardiac Surgery (FiCCS)