Fibrinogen Concentrate In Children Cardiac Surgery 2 (FiCCS2)

Filomena R B G Galas

Status and phase: Unknown; Phase 4

Conditions: C.Surgical Procedure; Cardiac; Hypofibrinogenemia; Blood Coagulation Disorders

Treatments: Drug: Fibrinogen Concentrate; Other: control

Study type: Interventional

Funder types: Other

Identifiers

NCT03884725

3864.12.120

Details and patient eligibility

About

The purporse of this study is evaluate whether fibrinogen concentrate reduces postoperative bleeding in pediatric cardiac surgery with cardiopulmonary by-pass.

Full 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. Fibrinogen concentrate (Haemocomplettan P)may reduce perioperative bleeding, requirements of blood transfusion and clinical outcomes in children undergoing cardiac surgery with pump.

Enrollment: 42 estimated patients

Sex: All

Ages: Under 10 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Cardiac surgery with pump
• Written informed consent
• Age under 28 days of life or RACHS-1 equal or greater than 3 or reoperation with age under 10 years

Exclusion criteria

• Coagulopathy (INR > 1.5)
• Low platelet count (lower than 100.000)
• Product or albumin allergy
• Active endocarditis
• Blalock-Taussig
• Heart transplant
• Anemia (hemoglobin < 10 g/dL)
• Impossibility to receive blood transfusion
• Hepatic dysfunction (total bilirubin > 1.5 mg/dL)
• Known or suspected hypersensitivity to fibrinogen concentrate
• Thrombophilia or previous thrombosis
• Participation in another study

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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42 participants in 2 patient groups, including a placebo group

fibrinogen concentrate

Active Comparator group

Description:

patients randomized to fibrinogen group receive intravenous infusion of drug prepared based on ROTEM measurement of maximum clot firmness (MCF)

Treatment:

Drug: Fibrinogen Concentrate

control

Placebo Comparator group

Description:

patients randomized to the control group will receive the infusion of 0.9% saline (SF0,9%) prepared based on ROTEM measurement of maximum clot firmness (MCF)

Treatment:

Other: control