Cardiac Surgical Procedures Clinical Trial
— FiCCSOfficial title:
Fibrinogen Concentrate to Treat Bleeding in Children Undergoing Cardiac Surgery With Pump: a Randomised Controlled Clinical Trial
Verified date | January 2013 |
Source | University of Sao Paulo |
Contact | n/a |
Is FDA regulated | No |
Health authority | Brazil: Ethics Committee |
Study type | Interventional |
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.
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | Incor - Heart Institute - University of Sao Paulo | Sao Paulo | SP |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo | CSL Behring |
Brazil,
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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