Fibrinogen Concentrate In Children After Cardiac Surgery

Phase 2

Completed

• Conditions: Cardiac Surgical Procedures; Blood Coagulation Disorders; Fibrinogen; Cryoprecipitate
• Interventions: Drug: Fibrinogen concentrate; Drug: Cryoprecipitate

• Registration Number: NCT01187225
• Lead Sponsor: University of Sao Paulo

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 Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-08-17
• Study First Submitted QC: 2010-08-23
• Study First Posted: 2010-08-24
• Primary Completion: 2011-01
• Study Completion: 2011-11
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-02
• Last Update Posted: 2013-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

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Exclusion Criteria

• Previous coagulopathy (clinical history or INR > 1.5)
• Low platelet count (lower than 100.000)
• Product allergy
• Urgent procedures
• Active infection

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fibrinogen concentrate	Fibrinogen concentrate	-
Cryoprecipitate	Cryoprecipitate	-

Primary Outcome Measures

Name	Time	Method
Number of patients receiving any allogeneic blood products	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 Outcome Measures

Name	Time	Method
Length of ICU stay	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	Up to hospital discharge	Clinical complications since intraoperative until hospital discharge
Mechanical ventilation free-days	Up to ICU discharge	Number of days without mechanical ventilation during ICU stay
Length of hospital stay	Up to hospital discharge	Number of days since arrival at ICU until hospital discharge
Vasopressors free-days	Up to ICU discharge	Number of days without vasopressors during ICU stay
intraoperative transfusion	intraoperative period	intraoperative requirements of any blood product (red blood cells, FFP, platelet concentrate and cryoprecipitate))
postoperative blood losses	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

Trial Locations

Locations (1)

Incor - Heart Institute - University of Sao Paulo; 🇧🇷 Sao Paulo, SP, Brazil