CLINICAL TRIAL

Hypothermic circulatory arrest for Aortic Diseases

Recruiting · 18+ · All Sexes · Ridgewood, NY

This study is evaluating whether mild hypothermia during aortic hemiarch surgery reduces the length of cardiopulmonary bypass time and other key measures of morbidity and mortality.

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About the trial for Aortic Diseases

Eligible Conditions
Aortic Diseases · Thoracic Aortic Diseases

Treatment Groups

This trial involves 2 different treatments. Hypothermic Circulatory Arrest is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Hypothermic circulatory arrest
PROCEDURE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Hypothermic circulatory arrest
PROCEDURE

Eligibility

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Elective aortic hemiarch surgery
(PUBLIC) is an ultrasound-guided technique that may be used to selectively perfuse the left ventricle with cardioplegia in the absence of cross-clamping the aorta show original
Age ≥ 18 years
The expected time for someone's lower body to be arrested is less than 20 minutes. show original
Being able to provide written informed consent means you are able to read and understand what you are signing, and are agreeing to it of your own free will. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 90 days after surgery.
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to 90 days after surgery.
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 90 days after surgery..
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Hypothermic circulatory arrest will improve 1 primary outcome and 12 secondary outcomes in patients with Aortic Diseases. Measurement will happen over the course of Up to 90 days after surgery..

Death
UP TO 90 DAYS AFTER SURGERY.
Comparison of mild (32°C) vs moderate (26°C) hypothermia in aortic hemiarch surgery with respect to the incidence of death
UP TO 90 DAYS AFTER SURGERY.
Incidence and quantity of perioperative blood transfusions
UP TO 90 DAYS AFTER SURGERY.
Comparison of mild (32°C) vs moderate (26°C) hypothermia in aortic hemiarch surgery with respect to the number and quantity of perioperative blood transfusions
UP TO 90 DAYS AFTER SURGERY.
Incidence of prolonged Mechanical Ventilation
UP TO 90 DAYS AFTER SURGERY.
Comparison of mild (32°C) vs moderate (26°C) hypothermia in aortic hemiarch surgery with respect to the duration of mechanical ventilation. Mechanical ventilation will be defined as use of a mechanical ventilator ≥48 hours.
UP TO 90 DAYS AFTER SURGERY.
Length of Stay
UP TO 90 DAYS AFTER SURGERY.
Comparison of mild (32°C) vs moderate (26°C) hypothermia in aortic hemiarch surgery with respect to the duration of a patient's stay in the intensive care unit and on the hospital ward.
UP TO 90 DAYS AFTER SURGERY.
Evaluate differences in the duration of cardiopulmonary bypass used in patients who receive mild or moderate hypothermic circulatory arrest during aortic hemiarch surgery
DURING THE INDEX PROCEDURE
Comparison of mild (32°C) vs moderate (26°C) hypothermia in aortic hemiarch surgery with respect to the length of time that the patient remains on cardiopulmonary bypass.
DURING THE INDEX PROCEDURE
Rates of Mediastinal re-exploration for bleeding
UP TO 90 DAYS AFTER SURGERY.
Comparison of mild (32°C) vs moderate (26°C) hypothermia in aortic hemiarch surgery with respect to the rates of mediastinal re-exploration (re-operation) for bleeding.
UP TO 90 DAYS AFTER SURGERY.
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of aortic diseases?

Most patients with aortic diseases present with symptoms. The majority of the symptoms are vague and the patients cannot remember them exactly, even when they occur intermittently. All symptoms could be secondary to another illness. The most important symptom of aortic aneurysm detection is the pain, a sudden, unexpected back discomfort. Symptoms are often associated with an abdominal bruit, pulsatile thoracoabdominal compression, or cardiac murmur.

Anonymous Patient Answer

Can aortic diseases be cured?

Aortic diseases cannot be cured. However, a correct diagnosis, early surgery, aggressive medical and surgical treatment and patient education lead to a low incidence of reinterventions.

Anonymous Patient Answer

What are common treatments for aortic diseases?

The aortic diseases common clinical presentation and pathophysiology is similar in both sexes. However, the clinical presentations and treatments among the aortic diseases in women are different from those in men. Patients with Marfan syndrome are treated with prophylactic surgery, and patients with Ehlers Danlos Syndrome are treated with anti-loosening therapy and rehabilitation exercises. Patients with Infantile Marfan Syndrome are treated predominantly with medical management (prophylaxis medications, bracing, and surgery options) and surgical treatment to relieve certain symptoms. Patients with aortic aneurysm are treated and managed in an interdisciplinary approach and are not treated with surgery.

Anonymous Patient Answer

What causes aortic diseases?

Aortic stenosis, aortic dilatation and dissections are often observed together. Patients with all of the signs and symptoms of aortic stenosis may have dilatation, dissections, degenerative and calcified lesions. The patients with dilatation and dissection need surgery. The occurrence of all three features together suggests that the aortic stenosis is the cause of the dissecting aneurysm and the dilated aorta. Surgical repair of aortic stenosis can prevent dissection or aneurysm formation.

Anonymous Patient Answer

What is aortic diseases?

The presence of atherosclerosis was shown in about one third of the patients, irrespective of the surgical procedures. The prevalence of aortic stenosis or aortic coarctation was low in both group of cases. However, it has to be stressed that the presence of atherosclerosis or stenosis are not the primary pathogenesis of aortic diseases.

Anonymous Patient Answer

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

About 26.6% of aortic disease are present in the US population. Aortic disease are more predominant in female patients (37.5%). This sex related incidence of aortic disease seems to be related to smoking and hypertriglyceridemia. Aortic disease seems to present earlier in patients older than 65 years than in younger patients. If surgically treated, aortic disease patients can expect a good life expectancy.

Anonymous Patient Answer

What is the latest research for aortic diseases?

Aortic aneurysm is a common disease that affects more than 740,000 people each year in the US. Aortic surgery leads to a low risk of death or major complications that can be reduced by minimizing nonessential surgeries and complications of surgery. The newest advances in cardiopulmonary bypass that may improve long-term survival following surgery for aortic diseases include the use of aprotinin during operations and extracorporeal oxygenation.

Anonymous Patient Answer

What does hypothermic circulatory arrest usually treat?

When assessing the effects of HCA in the treatment of EVAR, surgeons typically focus on the technical outcome of the procedure. Although technically accurate and safe, many patients experience more prolonged cardiogenic shock after EVAR with HCA. Although long-term outcomes of patients are mostly excellent, surgeons should focus on avoiding prolonged cardiogenic shock when performing EVAR using HCA.

Anonymous Patient Answer

Is hypothermic circulatory arrest safe for people?

The present study suggests that, with regard to the incidence and outcome of neurological deficits and death in an unselected population, the mean total cardiopulmonary bypass time in the first 30 days of operation was not associated with increased morbidity or mortality after aortic operations.

Anonymous Patient Answer

Does hypothermic circulatory arrest improve quality of life for those with aortic diseases?

The quality of life of both the patients with and the relatives of patients is generally low. The subjective quality of life of the patients worsens during the operation. Therefore, it is important for the aortic root replacement to consider a good postoperative quality of life. In a recent study, findings of the present study support the use of HCA.

Anonymous Patient Answer

Have there been any new discoveries for treating aortic diseases?

There has been a steady increase in both the survival and the prevention of new deaths due to cardiac disease in the United States since 1970. The most common cardiovascular diagnoses in the United States are coronary heart disease (CHD) (53 million) and peripheral vascular disease (9 million). There are two new advances that have contributed substantially to the treatment of aortic disease in the present report. The first is that advances related to prevention, surgery, and drug administration for CHD have resulted in an increase in the number of patients capable of surviving the disease after its onset.

Anonymous Patient Answer

How serious can aortic diseases be?

There is a strong correlation between the severity and extent of dissections in aortic aneurysms. The major predisposing factor for this condition is a combination of high systolic blood pressure and a long duration of hypertension (at least 45 years).

Anonymous Patient Answer
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