Clinical trial NCT01187225: Fibrinogen Concentrate In Children After Cardiac Surgery
Official title: Fibrinogen Concentrate to Treat Bleeding in Children Undergoing Cardiac Surgery With Pump: a Randomised Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cardiac Surgical Procedures
Blood Coagulation Disorders
Fibrinogen
Cryoprecipitate
Keywords: Cardiac surgical procedures
Fibrinogen
Bleeding
Cryoprecipitate
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: CSL Behring
First posted: 2010-08-24
Enrollment: 63
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of patients receiving any allogeneic blood products
timeFrame: From ICU admission until hospital discharge
Secondary outcomes:
measure: Length of ICU stay
timeFrame: Up to ICU discharge
measure: Clinical complications - renal failure, respiratory failure,sepsis, myocardial ischemia, stroke
timeFrame: Up to hospital discharge
measure: Mechanical ventilation free-days
timeFrame: Up to ICU discharge
measure: Length of hospital stay
timeFrame: Up to hospital discharge
measure: Vasopressors free-days
timeFrame: Up to ICU discharge
measure: intraoperative transfusion
timeFrame: intraoperative period
measure: postoperative blood losses
timeFrame: from ICU admission until hospital discharge
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Incor - Heart Institute - University of Sao Paulo
state: SP
Study officials:
References: