Cardiac Surgical ProceduresPhase 2FiCCSNCT01187225
Fibrinogen Concentrate In Children After Cardiac Surgery
A Phase 2 study testing Fibrinogen concentrate and Cryoprecipitate in people with Cardiac Surgical Procedures and Blood Coagulation Disorders, run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Cardiac Surgical Procedures, Blood Coagulation Disorders, Fibrinogen
- What is being tested?
- Fibrinogen concentrate and Cryoprecipitate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2010to Nov 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Previous coagulopathy (clinical history or INR > 1.5)
- Low platelet count (lower than 100.000)
- Product allergy
- Urgent procedures
- Active infection
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Incor - Heart Institute - University of Sao Paulo
São Paulo, São Paulo, 05403000
About this study
Official title: Fibrinogen Concentrate to Treat Bleeding in Children Undergoing Cardiac Surgery With Pump: a Randomised Controlled Clinical Trial
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.
Read the detailed 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.
- Being tested
- Fibrinogen concentrate, Cryoprecipitate
- Keywords
- Cardiac surgical procedures, Fibrinogen, Bleeding, Cryoprecipitate
- Medical subject headings
- Blood Coagulation Disorders, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibrinogen concentrateDrug
Also called Haemocompletan
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
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
| Study group | Role | What they receive |
|---|---|---|
| Fibrinogen concentrate | Active comparator | Not described Receives: Drug: Fibrinogen concentrate |
| Cryoprecipitate | Active comparator | Not described Receives: Drug: Cryoprecipitate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From ICU admission until hospital discharge
Secondary outcomes (7)
Length of ICU stay
Length of ICU stay - days since arrival at ICU until discharge
Measured: Up to ICU discharge
Clinical complications - renal failure, respiratory failure,sepsis, myocardial ischemia, stroke
Clinical complications since intraoperative until hospital discharge
Measured: Up to hospital discharge
Mechanical ventilation free-days
Number of days without mechanical ventilation during ICU stay
Measured: Up to ICU discharge
Length of hospital stay
Number of days since arrival at ICU until hospital discharge
Measured: Up to hospital discharge
Vasopressors free-days
Number of days without vasopressors during ICU stay
Measured: Up to ICU discharge
intraoperative transfusion
intraoperative requirements of any blood product (red blood cells, FFP, platelet concentrate and cryoprecipitate))
Measured: intraoperative period
postoperative blood losses
postoperative blood losses determined by the weight of dressings at intraoperative and chest tube drainage 12h and 24h after ICU admission
Measured: from ICU admission until hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionJan 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Surgical ProceduresStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- CSL Behring
- Responsible party
- Principal investigator, Ludhmila Abrahão Hajjar, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01187225
- Sponsor's protocol ID
- 0930/09
- Acronym
- FiCCS
- Status last verified
- Jan 2013
- First submitted
- 17 Aug 2010
- Last updated
- 4 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fibrinogen Concentrate to Treat Bleeding in Children Undergoing Cardiac Surgery With Pump: a Randomised Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT01187225
- Acronym / sponsor ID
- FiCCS / 0930/09
- Keywords
- Cardiac surgical procedures, Fibrinogen, Bleeding, Cryoprecipitate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- CSL Behring
- Study start
- Aug 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 24 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fibrinogen concentrate | Active comparator | Drug: Fibrinogen concentrate |
| Cryoprecipitate | Active comparator | Drug: Cryoprecipitate |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- Previous coagulopathy (clinical history or INR > 1.5)
- Low platelet count (lower than 100.000)
- Product allergy
- Urgent procedures
- Active infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fibrinogen concentrateAlso: HaemocompletanIn 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 | Drug | Fibrinogen concentrate |
| CryoprecipitateIn 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 | Drug | Cryoprecipitate |
Primary outcome
Number of patients receiving any allogeneic blood products
Time frame: From ICU admission until hospital discharge
Percentage of patients exposed to allogeneic blood products (red blood cells, FFP, platelet concentrate and cryoprecipitate) after ICU admission until hospital discharge.
7 secondary outcomes
Length of ICU stay
Time frame: Up to ICU discharge
Clinical complications - renal failure, respiratory failure,sepsis, myocardial ischemia, stroke
Time frame: Up to hospital discharge
Mechanical ventilation free-days
Time frame: Up to ICU discharge
Length of hospital stay
Time frame: Up to hospital discharge
Vasopressors free-days
Time frame: Up to ICU discharge
intraoperative transfusion
Time frame: intraoperative period
postoperative blood losses
Time frame: from ICU admission until hospital discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fibrinogen concentrate and Cryoprecipitate in people with Cardiac Surgical Procedures and Blood Coagulation Disorders, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients receiving any allogeneic blood products (time frame: From ICU admission until hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2013.