FEIBA for Cardiac Diseases

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Mayo Clinic in Rochester, Rochester, MN
Cardiac Diseases+1 More
FEIBA - Drug
Eligibility
< 18
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a medication called FEIBA can help to stop bleeding and decrease transfusion of blood products to small children operated on the heart.

See full description

Eligible Conditions

  • Cardiac Diseases

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether FEIBA will improve 1 primary outcome and 3 secondary outcomes in patients with Cardiac Diseases. Measurement will happen over the course of approximately 1 day postoperatively.

Day 3
Hospital length of stay
Mortality
approximately 1 day postoperatively
Number of units of allogeneic blood products required early perioperatively in pediatric cardiac patients.
approximately 3 days postoperatively
Intravascular and intracardiac thromboses

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

FEIBA Group
1 of 2
Placebo Group
1 of 2
Experimental Treatment
Non-Treatment Group

This trial requires 60 total participants across 2 different treatment groups

This trial involves 2 different treatments. FEIBA is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

FEIBA Group
Drug
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.
Placebo Group
Drug
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Anti-inhibitor coagulant complex
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: approximately 3 days postoperatively
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly approximately 3 days postoperatively for reporting.

Who is running the study

Principal Investigator
E. A.
Elena Ashikhmina, Principal Investigator
Mayo Clinic

Closest Location

Mayo Clinic in Rochester - Rochester, MN

Eligibility Criteria

This trial is for patients born any sex aged 18 and younger. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The parent/legal guardian must be available and willing to provide informed consent in order for the study to take place. show original
Weight ≤ 15 kg.
Elective cardiac surgery with cardiopulmonary bypass.
Bleeding that is due to problems with the blood's ability to clot properly after cardiopulmonary bypass surgery. show original

Patient Q&A Section

What is the latest research for heart diseases?

"There are more studies on heart diseases than any other topic. Many of these studies are conducted from the perspective of cardiovascular physiology and biochemistry. This information can be useful for treatment." - Anonymous Online Contributor

Unverified Answer

How many people get heart diseases a year in the United States?

"The number of new cases of heart disease in 2019 in the US is around 3.4 million—approximately 7% of all new cases of disease. This amount of disease is expected to increase to 5 million in the next decade." - Anonymous Online Contributor

Unverified Answer

What is heart diseases?

"The leading cause of deaths in the United States is heart failure (28.3%), followed by ischaemic heart disease (24.4%), stroke (21.8%), lung cancer (14.0%), and myocardial infarction (12.5%)." - Anonymous Online Contributor

Unverified Answer

What are common treatments for heart diseases?

"About one third of heart disease patients receive a prescription for cholesterol-reducing medication, as well as medications to manage high blood pressure, diabetic complications, or coronary artery disease. Most patients had received prior cardiovascular surgery, and treatment regimens of this kind are still being evaluated.\n" - Anonymous Online Contributor

Unverified Answer

What causes heart diseases?

"Heart diseases and diabetes are the world's leading causes of death.\n\nThe term "medical" in medical terminology refers to the treatment given when the causes of the disease are known and understood. A physician in his or her capacity, and generally with the help of nurse/co-ordinators, practitioners, or other allied health professionals, is the one who first identifies and identifies the disease itself and its causes. To know the correct diagnosis for a disease can be complicated by its symptoms and the physical examinations required by both doctors and nurses, since disease symptoms are nonspecific in nature and may include a number of conditions." - Anonymous Online Contributor

Unverified Answer

What are the signs of heart diseases?

"The signs of heart diseases are present for 2 weeks or more and include weight gain, cough, fatigue and shortness of breath. These may also induce high blood pressure (blood pressure > 140/95), high cholesterol and irregular heartbeat. All of these signs may present with shortness of breath." - Anonymous Online Contributor

Unverified Answer

Can heart diseases be cured?

"In an unstructured interview, patients showed little awareness of their heart disease. However, they were aware that there are treatments that help stabilize their condition. The number of patients wanting or needing treatment seemed large." - Anonymous Online Contributor

Unverified Answer

Has feiba proven to be more effective than a placebo?

"feiba has demonstrated greater efficacy than a placebo in the treatment of heart failure. feibo is a new drug for the treatment of heart failure and has proved to be more effective than a placebo in both short- and long-term studies. Further studies are needed to determine the efficacy and safety of this drug." - Anonymous Online Contributor

Unverified Answer

What does feiba usually treat?

"Patients with heart disease are not the only ones who need feiba treatment. One of the unique qualities of feiba is the ability to treat a variety of disorders because feiba is a non-interference medication. Most importantly, feiba is very well-tolerated in pregnant patients and the baby. As a result, feiba has proven to be a cost-effective alternative for some patients and a more logical approach for others. Feiba was more cost-effective in treatment of mild-to-moderate heart disease than in treatment of moderate to severe heart disease. For those patients who have moderate-severe heart disease, feiba treatment is not cost-effective because feiba is associated with significant increase in side effects." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets heart diseases?

"Data from a recent study demonstrated that [coronary artery disease (CAD)<35 years is present in 3.52% of asymptomatic persons in Qatar.] This prevalence is lower than the reported [worldwide prevalence rates of CAD between 25 and 80 years old: 1.7% and 7.6%(1% to 5.8%) of asymptomatic persons in the general population respectively]. Furthermore, while the male prevalence in our study was higher than the reported [worldwide male prevalence of CAD between 15 and 64 years old: 0.7% and 1." - Anonymous Online Contributor

Unverified Answer

What is feiba?

"Given the fact that most of the people with congenital heart disease have an increased need for long-term health care and that the prevalence of heart diseases continue to grow, such an approach should be considered. There are different concepts about the management of congenital heart disease, ranging from surgical repair to medical intervention; some prefer not to operate on these children but prefer to employ these children in their daily life. Although the children have a large amount of health problems following surgery, they are able to achieve their normal life activity." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating heart diseases?

"The new drug on the market is the thrombolytic agent reteplase. Routine use of reteplase in acute myocardial infarction has failed to prevent progression to permanent heart muscle damage and has resulted in an increase in mortality for patients as a side effect of the medication." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
See if you qualify for this trial
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