Platelets or Fibrinogen as First-line Treatment for Bleeding During Pedatric Heart Surgery
NCT ID: NCT04807621
Last Updated: 2021-03-19
Study Results
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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UNKNOWN
PHASE2
40 participants
INTERVENTIONAL
2018-03-14
2022-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Platelets
Patients recieve, in the presence of significant bleeding and pathological results of ROTEM analysis, a platelet transfusion.
Platelet transfusion
Platelets (10 ml/kg body weight) is transfused.
Fibrinogen
Patients recieve, in the presence of significant bleeding and pathological results of ROTEM analysis, fibrinogen concentrate.
Fibrinogen concentrate
Fibrinogen concentrate (300 mg/kg body weight) is administered.
Interventions
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Platelet transfusion
Platelets (10 ml/kg body weight) is transfused.
Fibrinogen concentrate
Fibrinogen concentrate (300 mg/kg body weight) is administered.
Eligibility Criteria
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Inclusion Criteria
* Body weight \< 10 kg.
* Expected CPB time \> 90 minutes.
Exclusion Criteria
12 Months
ALL
No
Sponsors
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Sahlgrenska University Hospital
OTHER
Responsible Party
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Fredrik Söderlund
Consultant, Anaesthesia and Intensive Care
Locations
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Sahlgrenska University Hospital
Gothenburg, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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FS52016
Identifier Type: -
Identifier Source: org_study_id
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