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Fibrinogen Concentrate In Children After Cardiac Surgery (FiCCS)

Primary Purpose

Cardiac Surgical Procedures, Blood Coagulation Disorders, Fibrinogen

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Fibrinogen concentrate
Cryoprecipitate
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Surgical Procedures focused on measuring Cardiac surgical procedures, Fibrinogen, Bleeding, Cryoprecipitate

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Incor - Heart Institute - University of Sao Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Fibrinogen concentrate

Cryoprecipitate

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
August 17, 2010
Last Updated
January 2, 2013
Sponsor
University of Sao Paulo
Collaborators
CSL Behring
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1. Study Identification

Unique Protocol Identification Number
NCT01187225
Brief Title
Fibrinogen Concentrate In Children After Cardiac Surgery
Acronym
FiCCS
Official Title
Fibrinogen Concentrate to Treat Bleeding in Children Undergoing Cardiac Surgery With Pump: a Randomised Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
CSL Behring

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Surgical Procedures, Blood Coagulation Disorders, Fibrinogen, Cryoprecipitate
Keywords
Cardiac surgical procedures, Fibrinogen, Bleeding, Cryoprecipitate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fibrinogen concentrate
Arm Type
Active Comparator
Arm Title
Cryoprecipitate
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Fibrinogen concentrate
Other Intervention Name(s)
Haemocompletan
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Cryoprecipitate
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of patients receiving any allogeneic blood products
Description
Percentage of patients exposed to allogeneic blood products (red blood cells, FFP, platelet concentrate and cryoprecipitate) after ICU admission until hospital discharge.
Time Frame
From ICU admission until hospital discharge
Secondary Outcome Measure Information:
Title
Length of ICU stay
Description
Length of ICU stay - days since arrival at ICU until discharge
Time Frame
Up to ICU discharge
Title
Clinical complications - renal failure, respiratory failure,sepsis, myocardial ischemia, stroke
Description
Clinical complications since intraoperative until hospital discharge
Time Frame
Up to hospital discharge
Title
Mechanical ventilation free-days
Description
Number of days without mechanical ventilation during ICU stay
Time Frame
Up to ICU discharge
Title
Length of hospital stay
Description
Number of days since arrival at ICU until hospital discharge
Time Frame
Up to hospital discharge
Title
Vasopressors free-days
Description
Number of days without vasopressors during ICU stay
Time Frame
Up to ICU discharge
Title
intraoperative transfusion
Description
intraoperative requirements of any blood product (red blood cells, FFP, platelet concentrate and cryoprecipitate))
Time Frame
intraoperative period
Title
postoperative blood losses
Description
postoperative blood losses determined by the weight of dressings at intraoperative and chest tube drainage 12h and 24h after ICU admission
Time Frame
from ICU admission until hospital discharge

10. Eligibility

Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Incor - Heart Institute - University of Sao Paulo
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05403000
Country
Brazil

12. IPD Sharing Statement

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Fibrinogen Concentrate In Children After Cardiac Surgery

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