Table of Contents
- Trial overview
- Aneurysmal subarachnoid hemorrhage study
- Pleural infection study
- Endpoints and measures
- What these trials mean for patients
Trial overview
The source data include two authorised interventional studies of Urokinase, meaning the researchers are testing planned treatments in patients rather than only watching what happens over time.[1][2]
One study is a Phase 2 randomized controlled trial in people with aneurysmal subarachnoid hemorrhage, and the other is a Phase 3 randomized controlled trial in people with pleural infections.[1][2]
Aneurysmal subarachnoid hemorrhage study
The first trial is titled SPLASH and studies patients with aneurysmal subarachnoid hemorrhage, also called aSAH.[1]
This study is testing stereotactic cisternal lavage therapy with Urokinase and Nimodipine, given through a stereotactically implanted catheter into the prepontine cistern, to see whether it improves neurological outcome and is safe in patients with aSAH.[1]
The trial is authorised, is in Phase 2, and plans to enroll 54 patients.[1]
This is a randomized controlled trial, which means patients are assigned by chance to study treatment groups so the results can be compared more fairly.[1]
Pleural infection study
The second trial is called EPISSOC and studies people with complicated pleural infections.[2]
This study compares an early pleural irrigation strategy with saline against the standard of care for managing these infections.[2]
Urokinase appears in the intervention list for this trial data, but the study summary focuses on comparing early pleural irrigation with standard care to reduce treatment failure.[2]
The trial is authorised, is in Phase 3, and plans to enroll 244 patients.[2]
This study is also randomized and controlled, so it is designed to compare outcomes between treatment strategies in a structured way.[2]
Endpoints and measures
The main result in the SPLASH trial is neurological outcome at 6 months after aSAH, measured with the modified Rankin Scale (mRS).[1]
In this study, a favorable result means mRS 0 to 3, which is described as independent, while an unfavorable result means mRS 4 to 6, which is described as dependent or dead.[1]
The main result in the EPISSOC trial is treatment failure at 30 days, defined as death, the need for thoracic surgery, or the need for additional intrapleural enzyme therapy after randomization.[2]
This kind of combined endpoint is called a composite outcome because it groups several important events into one study measure.[2]
What these trials mean for patients
These trials are focused on different patient groups, so Urokinase is being studied in more than one clinical setting.[1][2]
For patients with aSAH, the key question is whether the study treatment can improve recovery after a serious brain bleed.[1]
For patients with pleural infection, the key question is whether early irrigation can lower the chance of treatment failure compared with standard care.[2]
The source data do not list detailed entry rules, so the clearest information is that each trial is aimed at a specific condition and is measuring a specific outcome over time.[1][2]
