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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01187225
Other study ID # 0930/09
Secondary ID
Status Completed
Phase Phase 2
First received August 17, 2010
Last updated January 2, 2013
Start date August 2010
Est. completion date November 2011

Study information

Verified date January 2013
Source University of Sao Paulo
Contact n/a
Is FDA regulated No
Health authority Brazil: Ethics Committee
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 63
Est. completion date November 2011
Est. primary completion date January 2011
Accepts healthy volunteers No
Gender Both
Age group N/A to 18 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Drug:
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
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

Locations

Country Name City State
Brazil Incor - Heart Institute - University of Sao Paulo Sao Paulo SP

Sponsors (2)

Lead Sponsor Collaborator
University of Sao Paulo CSL Behring

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. From ICU admission until hospital discharge Yes
Secondary Length of ICU stay Length of ICU stay - days since arrival at ICU until discharge Up to ICU discharge Yes
Secondary Clinical complications - renal failure, respiratory failure,sepsis, myocardial ischemia, stroke Clinical complications since intraoperative until hospital discharge Up to hospital discharge Yes
Secondary Mechanical ventilation free-days Number of days without mechanical ventilation during ICU stay Up to ICU discharge Yes
Secondary Length of hospital stay Number of days since arrival at ICU until hospital discharge Up to hospital discharge No
Secondary Vasopressors free-days Number of days without vasopressors during ICU stay Up to ICU discharge No
Secondary intraoperative transfusion intraoperative requirements of any blood product (red blood cells, FFP, platelet concentrate and cryoprecipitate)) intraoperative period Yes
Secondary postoperative blood losses postoperative blood losses determined by the weight of dressings at intraoperative and chest tube drainage 12h and 24h after ICU admission from ICU admission until hospital discharge Yes
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