Cardiac DiseasePhase 2NCT05020483
FEIBA to Optimize Postcardiopulmonary Bypass Hemostasis in Pediatric Cardiac Patients
A Phase 2 study testing FEIBA in people with Cardiac Disease, run by Mayo Clinic.
Trial summary
The purpose of this research is to understand if the medication called FEIBA helps to stop bleeding and decrease transfusion of blood products to small children operated on the heart. Read more about this study
- Who is it for?
- Ages Up to 5 years
- Conditions the study is for
- Cardiac Disease
- What is being tested?
- FEIBA
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2021to Dec 2023
- 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 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Weight ≤ 15 kg.
- Elective cardiac surgery with cardiopulmonary bypass.
- Coagulopathic bleeding after cardiopulmonary bypass.
- Availability and willingness of the parent/legal guardian to provide informed consent.
Who cannot join
- Presence of mechanical circulatory support at the time of randomization or POD 0 and 1.
- Patient or family history of coagulopathy and/or thromboses.
- Preoperative anticoagulation (excluding low dose heparin for "line prophylaxis").
About this study
Official title: Activated Prothrombin Complex Concentrate FEIBA to Optimize Postcardiopulomonary Bypass Hemostasis in Pediatric Cardiac Patients
The purpose of this research is to understand if the medication called FEIBA helps to stop bleeding and decrease transfusion of blood products to small children operated on the heart.
- Conditions
- Cardiac Disease
- Being tested
- FEIBA, Placebo
- Keywords
- Cardiac Surgery
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FEIBADrug
Also called activated prothrombin complex concentrate (aPCC) FEIBA
Administered via the central line catheter after termination of cardiopulmonary bypass if bleeding related to poor clotting develops; in addition, according to conventional protocol blood products will be transfused simultaneously. Three small doses, 5 mg/kg each, will be available.
PlaceboDrug
Contains no active ingredient and administered via the central line catheter after termination of cardiopulmonary bypass if bleeding related to poor clotting develops; in addition, according to conventional protocol blood products will be transfused simultaneously.
| Study group | Role | What they receive |
|---|---|---|
| FEIBA Group | Experimental | Pediatric patients ≤15 kg of weight, undergoing cardiac surgery with cardiopulmonary bypass will receive activated prothrombin complex concentrate (aPCC) FEIBA to be incorporated into standard treatment of post-bypass coagulopathic bleeding. Receives: Drug: FEIBA |
| Placebo Group | Placebo comparator | Pediatric patients ≤15 kg of weight, undergoing cardiac surgery with cardiopulmonary bypass will receive a placebo to be incorporated into standard treatment of post-bypass coagulopathic bleeding. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of units of allogeneic blood products required early perioperatively in pediatric cardiac patients.
Number of units of transfused allogeneic blood products after cardiopulmonary bypass in the operating room (OR) and in the intensive care unit (ICU) on postoperative day (POD) 0 and 1.
Measured: approximately 1 day postoperatively
Secondary outcomes (3)
Hospital length of stay
Number of days admitted to the hospital
Measured: Through hospital discharge, approximately 3 days
Mortality
Total number of subject deaths
Measured: Through hospital discharge, approximately 3 days
Intravascular and intracardiac thromboses
Number of subjects to experience intravascular and/or intracardiac thromboses up to POD 3
Measured: approximately 3 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study startOct 2021 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Why it stopped: Patient population changed and no subjects eligible for the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac DiseaseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Ashikhmina, Mayo Clinic
- Investigators
- Elena Ashikhmina, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05020483
- Sponsor's protocol ID
- 21-005539
- Status last verified
- Nov 2022
- First submitted
- 18 Aug 2021
- Last updated
- 5 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Activated Prothrombin Complex Concentrate FEIBA to Optimize Postcardiopulomonary Bypass Hemostasis in Pediatric Cardiac Patients
- ClinicalTrials.gov ID
- NCT05020483
- Acronym / sponsor ID
- 21-005539
- Conditions
- Cardiac Disease
- Keywords
- Cardiac Surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Patient population changed and no subjects eligible for the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Oct 2021 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 25 Aug 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 purpose of this research is to understand if the medication called FEIBA helps to stop bleeding and decrease transfusion of blood products to small children operated on the heart.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FEIBA Group | Experimental | Drug: FEIBAPediatric patients ≤15 kg of weight, undergoing cardiac surgery with cardiopulmonary bypass will receive activated prothrombin complex concentrate (aPCC) FEIBA to be incorporated into standard treatment of post-bypass coagulopathic bleeding. |
| Placebo Group | Placebo comparator | Drug: PlaceboPediatric patients ≤15 kg of weight, undergoing cardiac surgery with cardiopulmonary bypass will receive a placebo to be incorporated into standard treatment of post-bypass coagulopathic bleeding. |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Weight ≤ 15 kg.
- Elective cardiac surgery with cardiopulmonary bypass.
- Coagulopathic bleeding after cardiopulmonary bypass.
- Availability and willingness of the parent/legal guardian to provide informed consent.
Key exclusion criteria (3 listed)
- Presence of mechanical circulatory support at the time of randomization or POD 0 and 1.
- Patient or family history of coagulopathy and/or thromboses.
- Preoperative anticoagulation (excluding low dose heparin for "line prophylaxis").
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 |
|---|---|---|
| FEIBAAlso: activated prothrombin complex concentrate (aPCC) FEIBAAdministered via the central line catheter after termination of cardiopulmonary bypass if bleeding related to poor clotting develops; in addition, according to conventional protocol blood products will be transfused simultaneously. Three small doses, 5 mg/kg each, will be available. | Drug | FEIBA Group |
| PlaceboContains no active ingredient and administered via the central line catheter after termination of cardiopulmonary bypass if bleeding related to poor clotting develops; in addition, according to conventional protocol blood products will be transfused simultaneously. | Drug | Placebo Group |
Primary outcome
Number of units of allogeneic blood products required early perioperatively in pediatric cardiac patients.
Time frame: approximately 1 day postoperatively
Number of units of transfused allogeneic blood products after cardiopulmonary bypass in the operating room (OR) and in the intensive care unit (ICU) on postoperative day (POD) 0 and 1.
3 secondary outcomes
Hospital length of stay
Time frame: Through hospital discharge, approximately 3 days
Mortality
Time frame: Through hospital discharge, approximately 3 days
Intravascular and intracardiac thromboses
Time frame: approximately 3 days postoperatively
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
Related trials for Cardiac Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
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.
Elena Ashikhmina, MD, PhD principal investigator
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FEIBA in people with Cardiac Disease, run by Mayo Clinic.
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 4 inclusion and 3 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: withdrawn, as of the sponsor's last update on 5 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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 units of allogeneic blood products required early perioperatively in pediatric cardiac patients. (time frame: approximately 1 day postoperatively). 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 5 Dec 2022.