Congenital Heart DiseasePhase 2NCT04807621
Platelets or Fibrinogen as First-line Treatment for Bleeding During Pedatric Heart Surgery
A Phase 2 study testing Platelet transfusion and Fibrinogen concentrate in people with Congenital Heart Disease, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
The study aims to test whether platelet transfusion or fibrinogen concentrate is the most effective treatment of intraoperative bleeding, when performing open heart surgery with cardiopulmonary bypass on children with congenital heart defects. Read more about this study
- Who is it for?
- Ages Up to 12 months
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- Platelet transfusion and Fibrinogen concentrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- 14 Mar 2018to Aug 2022
- 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 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children < 1 years of age, scheduled for open surgery of congenital heart defects, using cardiopulmonary bypass.
- Body weight < 10 kg.
- Expected CPB time > 90 minutes.
Who cannot join
- Known coagulation disorder, current treatment with antiplatelet and/or anticoagulant drugs, major surgery the past month before the planned surgery, preoperative kidney or liver failure (defined as creatinine and/or transaminases > normal interval for the patient´s age), gestational age < 34 weeks.
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Sahlgrenska University Hospital
Gothenburg
Fredrik Söderlund, MD, +46733829802, fredrik.soderlund@vgregion.se
Birgitta Romlin, MD, PhD, birgitta.romlin@vgregion.se
About this study
Official title: Platelets or Fibrinogen as First-line Treatment for Bleeding During Pedatric Heart Surgery: a Randomized, Controlled Trial.
The study aims to test whether platelet transfusion or fibrinogen concentrate is the most effective treatment of intraoperative bleeding, when performing open heart surgery with cardiopulmonary bypass on children with congenital heart defects.
- Conditions
- Congenital Heart Disease
- Being tested
- Platelet transfusion, Fibrinogen concentrate
- Keywords
- Bleeding, Coagulopathy, Heart surgery, Cardiopulmonary bypass
- Medical subject headings
- Heart Defects, Congenital, Hemorrhage, Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet transfusionBiological
Platelets (10 ml/kg body weight) is transfused.
Fibrinogen concentrateBiological
Fibrinogen concentrate (300 mg/kg body weight) is administered.
| Study group | Role | What they receive |
|---|---|---|
| Platelets | Active comparator | Patients recieve, in the presence of significant bleeding and pathological results of ROTEM analysis, a platelet transfusion. Receives: Biological: Platelet transfusion |
| Fibrinogen | Experimental | Patients recieve, in the presence of significant bleeding and pathological results of ROTEM analysis, fibrinogen concentrate. Receives: Biological: Fibrinogen concentrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
HEPTEM-A10
The outcome measure is a measure of global coagulation efficacy, obtained by ROTEM analysis.
Measured: 45 minutes after intervention
Secondary outcomes (1)
Amount of transfused packed red blood cells
Measured: up to first postoperative morning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start14 Mar 2018
- Primary completionJan 2022 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fredrik Söderlund, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04807621
- Sponsor's protocol ID
- FS52016
- Status last verified
- Mar 2021
- First submitted
- 18 Mar 2021
- Last updated
- 19 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelets or Fibrinogen as First-line Treatment for Bleeding During Pedatric Heart Surgery: a Randomized, Controlled Trial.
- ClinicalTrials.gov ID
- NCT04807621
- Acronym / sponsor ID
- FS52016
- Conditions
- Congenital Heart Disease
- Keywords
- Bleeding, Coagulopathy, Heart surgery, Cardiopulmonary bypass
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- 14 Mar 2018 (actual)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 19 Mar 2021 (actual)
- 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 study aims to test whether platelet transfusion or fibrinogen concentrate is the most effective treatment of intraoperative bleeding, when performing open heart surgery with cardiopulmonary bypass on children with congenital heart defects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Platelets | Active comparator | Biological: Platelet transfusionPatients recieve, in the presence of significant bleeding and pathological results of ROTEM analysis, a platelet transfusion. |
| Fibrinogen | Experimental | Biological: Fibrinogen concentratePatients recieve, in the presence of significant bleeding and pathological results of ROTEM analysis, fibrinogen concentrate. |
Who may qualify
- Ages
- Up to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children < 1 years of age, scheduled for open surgery of congenital heart defects, using cardiopulmonary bypass.
- Body weight < 10 kg.
- Expected CPB time > 90 minutes.
Key exclusion criteria (1 listed)
- Known coagulation disorder, current treatment with antiplatelet and/or anticoagulant drugs, major surgery the past month before the planned surgery, preoperative kidney or liver failure (defined as creatinine and/or transaminases > normal interval for the patient´s age), gestational age < 34 weeks.
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 |
|---|---|---|
| Platelet transfusionPlatelets (10 ml/kg body weight) is transfused. | Biological | Platelets |
| Fibrinogen concentrateFibrinogen concentrate (300 mg/kg body weight) is administered. | Biological | Fibrinogen |
Primary outcome
HEPTEM-A10
Time frame: 45 minutes after intervention
The outcome measure is a measure of global coagulation efficacy, obtained by ROTEM analysis.
1 secondary outcome
Amount of transfused packed red blood cells
Time frame: up to first postoperative morning
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2021.
- Individual participant dataSharing planned: No
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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.
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 Platelet transfusion and Fibrinogen concentrate in people with Congenital Heart Disease, run by Sahlgrenska University Hospital at 1 site in Sweden.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 19 Mar 2021. 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 Sweden. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fredrik Söderlund, MD (+46 31 343 6895, fredrik.soderlund@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HEPTEM-A10 (time frame: 45 minutes after intervention). 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 19 Mar 2021; AzTrials last refreshed its copy on 6 Nov 2026.