Fibrinogen Concentrate In Children After Cardiac Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2011-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cardiac Surgical Procedures Blood Coagulation Disorders Fibrinogen Cryoprecipitate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Fibrinogen concentrate

Group Type ACTIVE_COMPARATOR

Fibrinogen concentrate

Intervention Type 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

Cryoprecipitate

Group Type ACTIVE_COMPARATOR

Cryoprecipitate

Intervention Type 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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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Haemocompletan

Eligibility Criteria

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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

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No