In short
Clinical trials investigating Trometamol are studying different hospital settings, including major cardiac surgery and brain-dead organ donors. These studies aim to compare treatment approaches, measure safety and effectiveness, and see how well patients or donors tolerate the study care. The target groups are adults undergoing heart surgery and brain-dead organ donors.
Key points
- Clinical trials investigating Trometamol are focused on two hospital settings: major cardiac surgery and brain-dead organ donation care. One study is Phase 3 and compares two cardioplegia strategies in patients having heart surgery with extracorporeal circulation. The other is Phase 2 and looks at hemodynamic tolerance in brain-dead organ donors who may provide kidney or multiple organs. The trials measure important outcomes such as death, heart attack, kidney failure, circulation stability, and the need for blood pressure medicines or fluids. Both studies are authorised and are designed to compare clinical results in specific patient groups.
Trial overview
The available trial data for Trometamol includes two authorised interventional studies in hospital settings. One study is in major cardiac surgery, and the other is in brain-dead organ donors.
Cardiac surgery study
The first study is the CARDIO-HEART clinical trial, which evaluates the clinical impact of the type of cardioplegia used during major cardiac surgery with extracorporeal circulation. The trial compares Custodiol crystalloid cardioplegia with Buckberg blood cardioplegia and aims to show that Custodiol is not worse than Buckberg in this setting.
This study is in Phase 3 and plans to include 600 patients. It is designed for patients having major heart surgery with prolonged aortic clamping times, which means the aorta is closed for a longer period during the operation.
Organ donor study
The second study looks at the hemodynamic tolerance of potassium canrenoate in brain-dead organ donors. The brief summary says the goal is to assess the effect of potassium canrenoate versus placebo on circulation in brain-dead subjects who are candidates for kidney or multiple organ harvesting, including the kidney.
This study is in Phase 2 and plans to include 36 participants. The intervention and comparison are given by vein, and the study is focused on how well the donor’s circulation stays stable before organ removal.
Key outcomes being measured
In the cardiac surgery study, the main outcome is a combined measure of death, perioperative acute heart attack, low heart output needing inotropic drugs, and severe acute kidney failure at 90 days after the intervention. A combined measure means several important events are grouped together into one result.
In the organ donor study, the main outcome is a hierarchical composite of events. This includes cardiac arrest before organ removal, inability to perform the renal swab, the average hourly dose of noradrenaline or adrenaline, and the average hourly amount of crystalloids or colloids used between randomisation and departure to the operating room.
Who can participate
The cardiac surgery trial is for patients undergoing major cardiac surgery with extracorporeal circulation and prolonged aortic clamping times. The donor trial is for brain-dead organ donors who are candidates for kidney or multiple organ harvesting.
These are highly specific groups, so the studies are not for general use in the community. They are designed for patients or donors already in a surgical or intensive care setting.
Trial phases and status
Both studies are listed as Authorised, which means they have been approved to start. The cardiac surgery study is Phase 3, while the donor study is Phase 2.
Phase 3 studies usually compare treatments in a larger group and look closely at clinical results. Phase 2 studies usually focus on early testing of how a treatment performs in a smaller group and whether it is tolerated well.
The two studies together show that Trometamol-related trial data is being used in different urgent care settings, with different goals and patient groups.