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Fibrinogen Concentrate In Children After Cardiac Surgery (FiCCS)

U

University of Sao Paulo

Status and phase

Completed
Phase 2

Conditions

Fibrinogen
Cryoprecipitate
Cardiac Surgical Procedures
Blood Coagulation Disorders

Treatments

Drug: Fibrinogen concentrate
Drug: Cryoprecipitate

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01187225
0930/09

Details and patient eligibility

About

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.

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. 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.

Enrollment

63 patients

Sex

All

Ages

Under 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

63 participants in 2 patient groups

Fibrinogen concentrate
Active Comparator group
Treatment:
Drug: Fibrinogen concentrate
Cryoprecipitate
Active Comparator group
Treatment:
Drug: Cryoprecipitate

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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