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Fibrinogen Concentrate In Children After Cardiac Surgery (FiCCS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01187225
Recruitment Status : Completed
First Posted : August 24, 2010
Last Update Posted : January 4, 2013
Sponsor:
Collaborator:
CSL Behring
Information provided by (Responsible Party):
Ludhmila Abrahão Hajjar, University of Sao Paulo

Tracking Information
First Submitted Date  ICMJE August 17, 2010
First Posted Date  ICMJE August 24, 2010
Last Update Posted Date January 4, 2013
Study Start Date  ICMJE August 2010
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 2, 2013)
Number of patients receiving any allogeneic blood products [ Time Frame: From ICU admission until hospital discharge ]
Percentage of patients exposed to allogeneic blood products (red blood cells, FFP, platelet concentrate and cryoprecipitate) after ICU admission until hospital discharge.
Original Primary Outcome Measures  ICMJE
 (submitted: August 23, 2010)
Number of patients not receiving any allogeneic blood products [ Time Frame: From intraoperative until hospital discharge ]
Proportion of subjects that receive no allogeneic blood products (neither red blood cells, fresh frozen plasma nor platelets)from surgery until the hospital discharge
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 2, 2013)
  • Length of ICU stay [ Time Frame: Up to ICU discharge ]
    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 ]
    Clinical complications since intraoperative until hospital discharge
  • Mechanical ventilation free-days [ Time Frame: Up to ICU discharge ]
    Number of days without mechanical ventilation during ICU stay
  • Length of hospital stay [ Time Frame: Up to hospital discharge ]
    Number of days since arrival at ICU until hospital discharge
  • Vasopressors free-days [ Time Frame: Up to ICU discharge ]
    Number of days without vasopressors during ICU stay
  • intraoperative transfusion [ Time Frame: intraoperative period ]
    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 ]
    postoperative blood losses determined by the weight of dressings at intraoperative and chest tube drainage 12h and 24h after ICU admission
Original Secondary Outcome Measures  ICMJE
 (submitted: August 23, 2010)
  • Length of ICU stay [ Time Frame: Up to ICU discharge ]
    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 ]
    Clinical complications since intraoperative until hospital discharge
  • Requirements of transfusion [ Time Frame: Up to hospital discharge ]
    Number of transfused blood products during hospital stay
  • Mechanical ventilation free-days [ Time Frame: Up to ICU discharge ]
    Number of days without mechanical ventilation during ICU stay
  • Length of hospital stay [ Time Frame: Up to hospital discharge ]
    Number of days since arrival at ICU until hospital discharge
  • Vasopressors free-days [ Time Frame: Up to ICU discharge ]
    Number of days without vasopressors during ICU stay
  • Perioperative bleeding [ Time Frame: Within 72 hours ]
    Bleeding in intraoperative room and during 72 hours of ICU stay
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fibrinogen Concentrate In Children After Cardiac Surgery
Official Title  ICMJE Fibrinogen Concentrate to Treat Bleeding in Children Undergoing Cardiac Surgery With Pump: a Randomised Controlled Clinical Trial
Brief 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Cardiac Surgical Procedures
  • Blood Coagulation Disorders
  • Fibrinogen
  • Cryoprecipitate
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Active Comparator: Fibrinogen concentrate
    Intervention: Drug: Fibrinogen concentrate
  • Active Comparator: Cryoprecipitate
    Intervention: Drug: Cryoprecipitate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 17, 2012)
63
Original Estimated Enrollment  ICMJE
 (submitted: August 23, 2010)
80
Actual Study Completion Date  ICMJE November 2011
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01187225
Other Study ID Numbers  ICMJE 0930/09
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ludhmila Abrahão Hajjar, University of Sao Paulo
Study Sponsor  ICMJE University of Sao Paulo
Collaborators  ICMJE CSL Behring
Investigators  ICMJE Not Provided
PRS Account University of Sao Paulo
Verification Date January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP