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Brain Death clinical trials

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NCT ID: NCT06279975 Recruiting - Brain Death Clinical Trials

Pupillometric Evaluation in Patients Declared Brain Dead - a Prospective Quality Control Study

INSPECT
Start date: December 18, 2023
Phase:
Study type: Observational

The aim of the study is to verify the reliability of the current purely clinical examination of the pupils (without the support of a pupillometer) in the context of clinically suspected brain death, compared to the results of a non-invasive, automated, and highly precise monocular pupillometric examination.

NCT ID: NCT05950178 Recruiting - Brain Death Clinical Trials

Validation of the Apnea Test Performed by High-flow Oxygen Therapy in Patients With Clinical Brain Death

APNEAFLOW
Start date: July 10, 2023
Phase: N/A
Study type: Interventional

Brain death is a clinical and paraclinical diagnosis established in a known etiological context. It involves the irreversible destruction of cerebral functions in a beating-heart individual. In the context of organ and tissue donation from a critically ill patient, the clinical diagnosis of brain death is confirmed through a mandatory apnea test. This test is conducted by disconnecting the patient from the ventilator for a duration of 8 to 10 minutes. The test is considered validated when there is no spontaneous respiratory movement and the presence of hypercapnia. Hypercapnia is defined as a PaCO2 (carbon dioxide partial pressure) greater than 60 mmHg or an increase of more than 20 mmHg compared to the pre-ventilator disconnection capnia. These thresholds are meant to provide a strong stimulus to the respiratory centers, objectively confirming the absence of spontaneous ventilation. In practice, the apnea test is performed under CPAP (Continuous Positive Airway Pressure) or by administering oxygen at 6-10L/min through the endotracheal tube. High-flow oxygenation could be a simple alternative for the apnea test during the validation of the clinical diagnosis of brain death while reducing the risk of lung derecruitment and compromising organ viability and/or lung donation. However, due to the high gas flow used (60 L/min), high-flow oxygenation can lead to a "washout" effect in the anatomical dead space, which may lower the carbon dioxide partial pressure. Consequently, even in a patient in a state of brain death, where spontaneous ventilation is absent by definition, it is not certain that the carbon dioxide partial pressure will increase to the threshold of 60 mmHg or more than 20 mmHg in 10 minutes during an apnea test conducted with high-flow oxygenation. The purpose of this study is, therefore, to examine the feasibility of clinically diagnosing brain death through an apnea test performed with high-flow oxygenation. To determine whether the validation criterion which involves observing an arterial capnia > 60 mmHg or an increase > 20 mmHg (compared to the capnia at the beginning of the test) after 10 minutes can be achieved during an apnea test conducted under high-flow oxygen therapy in patients with clinically confirmed brain death by standard apnea test (under standard oxygen therapy)

NCT ID: NCT05609123 Recruiting - Clinical trials for Organ Transplant Failure or Rejection

Endothelial Glycocalyx Damage in Brain Death Organ Donors

Start date: January 1, 2022
Phase:
Study type: Observational

The study aims the assessment of endothelial glycocalyx (EG) degradation in deceased organ donors. There is a lack of organs for the transplantation program. By the description of the EG status, we can open room for organ optimization before transplantation and improve the organ function after transplantation in marginal donors.

NCT ID: NCT05202886 Recruiting - Brain Death Clinical Trials

"LiverColor": Machine Learning in Liver Photographs

Start date: June 30, 2018
Phase: N/A
Study type: Interventional

The main goal of this project is to create a machine learning model in order to quantify liver steatosis in liver donor faster, more objective and reliable than histological analysis and surgeons point-of-view.

NCT ID: NCT05148715 Recruiting - Brain Death Clinical Trials

Calcineurin Inhibitor in NEuRoloGically Deceased Donors to Decrease Kidney delaYed Graft Function (CINERGY)

CINERGY
Start date: July 11, 2022
Phase: Phase 2
Study type: Interventional

The investigators hypothesize that preconditioning neurologically deceased organ donors with the calcineurin inhibitor tacrolimus will improve short and long-term transplant survival without causing harm. Organ donors will be randomized to receive either 0.02 mg/kg ideal body weight (IBW) of tacrolimus single infusion or placebo before organ recovery. All corresponding recipients are enrolled and data is collected up to 7 days post-transplant to determine graft function and at 1 year to collect outcomes of vital status, re-transplantation and dialysis. The CINERGY Pilot Trial assesses feasibility for the main trial.

NCT ID: NCT04914039 Recruiting - Brain Death Clinical Trials

Evaluation of CTA on the Assessment of Brain Death

Start date: February 1, 2021
Phase:
Study type: Observational [Patient Registry]

At present, different countries have different standards for the diagnosis of brain death, but according to the classic brain death confirmation test, it needs to be combined with transcranial Doppler, EEG, evoked potential and apnea test in clinical practice. Some patients cannot undergo a complete clinical examination and apnea test due to certain factors, and the determination of brain death is limited. The American Academy of Neurology (AAN) guidelines regard cerebral angiography as an acceptable auxiliary examination and is widely regarded as the gold standard for cerebral blood flow evaluation. CT cerebrovascular angiography (CTA) is a noninvasive and widely used examination method that can identify missing or severely reduced cerebral blood flow. However, due to limited experience and lack of sufficient evidence to prove its reliability, it is not included in the AAN A recognized auxiliary examination; there are also a large number of domestic and foreign literature reports that CTA can be used as a new confirmation test for clinical judgment of brain death. This study aims to explore the value of CTA in the judgment of patients with brain death.

NCT ID: NCT04734574 Recruiting - Brain Death Clinical Trials

Methods of Confirmation of Brain Death

Start date: April 1, 2022
Phase:
Study type: Observational

The purpose of this study is to describe the use of methods confirming brain death in the real clinical practice of the transplant program in the Czech Republic.

NCT ID: NCT04714710 Recruiting - Clinical trials for Brain-dead Organ Donors

Potassium Canrenoate in Brain-dead Organ Donors: Randomized Controlled Clinical Trial

CANREO-PMO
Start date: August 26, 2021
Phase: Phase 2
Study type: Interventional

Given the current organ shortage, improving the quality/efficacy of harvested grafts from expanded criteria donors is essential to substantially increase the number of potential donors. Preclinical studies have shown that blocking the vascular mineralocorticoid receptor (MR) mitigates ischemia-reperfusion injury (I/R) and prevents renal dysfunction following acute kidney injury. Potassium canrenoate is an intravenous MR antagonist. Blocking the MR upstream from aortic cross clamping is likely the most effective strategy to limit I/R injury. Yet, brain-dead donors are prone to severe hemodynamic instability and polyuria. Consequently, this study seeks to assess the hemodynamic tolerance of the use of potassium canrenoate in this context, as a first step to a large-scale clinical trial testing the impact of this therapeutic intervention on the survival of kidney grafts.

NCT ID: NCT04404972 Recruiting - Brain Death Clinical Trials

Incidence of Complications of Brain Death

Start date: April 1, 2022
Phase:
Study type: Observational

The purpose of the study is to describe the incidence of complications in brain death adult organ donors.

NCT ID: NCT04127266 Recruiting - Clinical trials for Unallocated Pancreas Organs

Expanding Pancreas Donor Pool by Evaluation of Unallocated Organs After Brain Death - The EXPLORE Study

Start date: November 1, 2019
Phase:
Study type: Observational

Pancreas graft quality directly affects morbidity and mortality rates after pancreas transplantation (PTx). The criteria for pancreas graft allocation are restricted, which has decreased the number of available organs. Suitable pancreatic allografts are selected based on donor demographics, medical history, and the transplant surgeon's assessment of organ quality during procurement. Quality is assessed based on macroscopic appearance, which is biased by individual experience and personal skills. Therefore, the aim of this study is to assess the histopathological quality of unallocated pancreas organs to determine how many unallocated organs are of suitable quality for PTx, based on histopathologic evaluations. The reasons for allocation rejection will be reported and the correlation between cause of allocation rejection and histopathological quality of the allocated organ will be evaluated. This is a multicenter cross-sectional explorative study. The demographic data and medical history of donor and cause of rejection of the allocation of graft will be recorded. Organs of included donors will be explanted and macroscopic features such as weight, color, size, and stiffness will be recorded. A tissue sample of the organ will be fixed for further microscopic assessments. Histopathologic assessments will be reported 6 hours (or at time of organ delivery if later than 6 hours), 9 hours, 12 hours, 15 hours, and 18 hours after procurement. 100 pancreases will be evaluated in this study.