NCT01187225

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

August 17, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 24, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

January 4, 2013

Status Verified

January 1, 2013

Enrollment Period

5 months

First QC Date

August 17, 2010

Last Update Submit

January 2, 2013

Conditions

Cardiac Surgical ProceduresBlood Coagulation DisordersFibrinogenCryoprecipitate

Keywords

Cardiac surgical proceduresFibrinogenBleedingCryoprecipitate

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (7)

  • Length of ICU stay

    Up to ICU discharge

  • Clinical complications - renal failure, respiratory failure,sepsis, myocardial ischemia, stroke

    Up to hospital discharge

  • Mechanical ventilation free-days

    Up to ICU discharge

  • Length of hospital stay

    Up to hospital discharge

  • Vasopressors free-days

    Up to ICU discharge

  • +2 more secondary outcomes

Study Arms (2)

Fibrinogen concentrate

ACTIVE COMPARATOR
Drug: Fibrinogen concentrate

Cryoprecipitate

ACTIVE COMPARATOR
Drug: Cryoprecipitate

Interventions

Fibrinogen concentrateDRUG

In this arm, children (\< 18 year-old)undergoing cardiac surgery with pump will receive fibrinogen concentrate (60 mg/Kg) if they present clinically significant bleeding associated to low levels of fibrinogen (\< 1g/L) or TEG \< 7 mm

Also known as: Haemocompletan
Fibrinogen concentrate
CryoprecipitateDRUG

In this arm, children (\< 18 year-old)undergoing cardiac surgery with pump will receive cryoprecipiate (10 ml/Kg) if they present clinically significant bleeding associated to low levels of fibrinogen (\< 1g/L) or TEG \< 7 mm

Cryoprecipitate

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Previous coagulopathy (clinical history or INR \> 1.5)
  • Low platelet count (lower than 100.000)
  • Product allergy
  • Urgent procedures
  • Active infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Incor - Heart Institute - University of Sao Paulo

São Paulo, São Paulo, 05403000, Brazil

Location

MeSH Terms

Conditions

Blood Coagulation DisordersHemorrhage

Interventions

Fibrinogencryoprecipitate coagulum

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acute-Phase ProteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsBlood Coagulation FactorsProtein PrecursorsBiological Factors

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 17, 2010

First Posted

August 24, 2010

Study Start

August 1, 2010

Primary Completion

January 1, 2011

Study Completion

November 1, 2011

Last Updated

January 4, 2013

Record last verified: 2013-01

Locations

BR(1)