Skip to main content
OpenTrials
Completed

NCT Number: NCT01187225

Fibrinogen Concentrate In Children After Cardiac Surgery

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cardiac Surgical Procedures Blood Coagulation Disorders Cryoprecipitate Fibrinogen Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Incor - Heart Institute - University of Sao Paulo

São Paulo, 05403000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fibrinogen concentrate

Drug

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

Cryoprecipitate

Drug

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 outcomes

  1. 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.

Secondary outcomes

  1. Length of ICU stay

    Time frame: Up to ICU discharge

    Length of ICU stay - days since arrival at ICU until discharge

  2. Clinical complications - renal failure, respiratory failure,sepsis, myocardial ischemia, stroke

    Time frame: Up to hospital discharge

    Clinical complications since intraoperative until hospital discharge

  3. Mechanical ventilation free-days

    Time frame: Up to ICU discharge

    Number of days without mechanical ventilation during ICU stay

  4. Length of hospital stay

    Time frame: Up to hospital discharge

    Number of days since arrival at ICU until hospital discharge

  5. Vasopressors free-days

    Time frame: Up to ICU discharge

    Number of days without vasopressors during ICU stay

  6. intraoperative transfusion

    Time frame: intraoperative period

    intraoperative requirements of any blood product (red blood cells, FFP, platelet concentrate and cryoprecipitate))

  7. 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

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • CSL Behring

Registry information

Official study title

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

Acronym: FiCCS

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Aug 24, 2010
Registry last updated
Jan 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.