Fibrinogen Concentrate In Children Cardiac Surgery 2

NCT03884725 | Unknown Phase 4

• 1 other identifier: 3864.12.120
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

Cardiac surgical procedures; Fibrinogen; Bleeding

Outcome Measures

Primary Outcomes (1)

• The amount of postoperative bleeding

  The amount of blood loss (tube drainage) in the first 6 hours of ICU admission and daily until the seventh day of ICU. Re-exploration is mandatory if the patient presente excessive bleeding not responsive to clinical measures (warming, coagulopathy correction and/or thrombocytopenia correction), associated hemodynamic instability or evidence of cardiac tamponade.

  Within 7 days after cardiac surgery

Secondary Outcomes (13)

• The amount and type of blood transfusion

  within 7 days after cardiac surgery

• Rate of acute kidney injury

  within 28 days after cardiac surgery

• Rate of cardiac complications

  within 28 days after cardiac surgery

• Rate of neurological complications

  within 28 days after cardiac surgery

• Rate of infection complications

  within 28 days after cardiac surgery

Study Arms (2)

fibrinogen concentrate

ACTIVE COMPARATOR

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

Drug: Fibrinogen Concentrate

control

PLACEBO COMPARATOR

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)

Other: control

Interventions

Fibrinogen Concentrate DRUG

Fibrinogen Concentrate is to be administered as an intravenous infusion after discontinuation of cardiopulmonary bypass and administration of protamine. Subjects are to be given Fibrinogen Concentrate at an individually determined dose based on FIBTEM MCF and body weight as follows: (15 \[mm\] - MCF \[mm\]) \* body weight \[kg\] / 140 \[mm\*kg/g\] = gram fibrinogen to be dosed as Fibrinogen Concentrate. Fibrinogen Concentrate is to be infused over 1 to 2 minutes. After Fibrinogen Concentrate infusion, bleeding treatment will follow the predefined, standardized treatment regimen.

fibrinogen concentrate

control OTHER

0.9% saline is to be administered as an intravenous infusion after discontinuation of cardiopulmonary bypass and administration of protamine. 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). 0.9% saline is to be infused over 1 to 2 minutes. After 0.9% saline infusion, bleeding treatment will follow the predefined, standardized treatment regimen.

control

Eligibility Criteria

• Age: Up to 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Filomena R B G Galas: lead

Study Sites (1)

Incor - Heart Institute - University of Sao Paulo

São Paulo, 05403000, Brazil

RECRUITING

Related Publications (1)

• Galas FR, de Almeida JP, Fukushima JT, Vincent JL, Osawa EA, Zeferino S, Camara L, Guimaraes VA, Jatene MB, Hajjar LA. Hemostatic effects of fibrinogen concentrate compared with cryoprecipitate in children after cardiac surgery: a randomized pilot trial. J Thorac Cardiovasc Surg. 2014 Oct;148(4):1647-55. doi: 10.1016/j.jtcvs.2014.04.029. Epub 2014 Apr 18.

  PMID: 24951020 RESULT

Related Links

• Bleeding, Bleeding Disorders, Heart Surgery
• Fibrinogen Concentrate

MeSH Terms

Conditions

Blood Coagulation Disorders; Afibrinogenemia; Hemorrhage

Interventions

Fibrinogen

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Blood Coagulation Disorders, Inherited; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acute-Phase Proteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Blood Coagulation Factors; Protein Precursors; Biological Factors

Study Officials

• Filomena RG Galas

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Filomena RG Galas

CONTACT

+551126615232; filomenagalas@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology at University São Paulo Medical School

Study Record Dates

• First Submitted: March 18, 2019
• First Posted: March 21, 2019
• Study Start: March 1, 2019
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: March 21, 2019

Record last verified: 2019-03

Locations

BR (1)