In short
Clinical trials of HUMAN PLASMA are studying whether early use of plasma in emergency care can help patients with haemorrhagic shock. These studies look at how well it works, how fast patients stabilize, and whether it can reduce the need for other infusion fluids. The target group is patients treated in the emergency room for severe blood loss.
Key points
- Clinical trials of HUMAN PLASMA are focused on patients with haemorrhagic shock, a serious condition caused by severe blood loss. The main study in the data is a Phase 3 interventional trial called ELIPS-Trial. It is testing whether early plasma use in the emergency room works better than standard crystalloid infusion solutions. The trial is also looking at faster hemodynamic stabilization and lower lactate levels as signs of improvement. Another goal is to see whether HUMAN PLASMA can reduce the amount of other fluids needed and help avoid volume overload.
Trial overview
The available clinical trial data describe one study, the ELIPS-Trial, which is testing HUMAN PLASMA in patients with haemorrhagic shock. The study is authorised and is being run as an interventional trial, which means researchers are giving a treatment and then measuring the results.
This trial compares early administration of lyophilized plasma with conventional crystalloid infusion solutions in the emergency room. The study team wants to know if earlier plasma use can help patients stabilize faster after major blood loss.
Study design and phase
The ELIPS-Trial is a Phase 3 study with an enrollment of 30 participants. Phase 3 studies usually test whether a treatment works well in a larger patient group and compare it with standard care.
In this trial, the intervention listed for HUMAN PLASMA is LyoPlas N - W, which is a lyophilized, or freeze-dried, plasma product. The comparison treatment is ELO-MEL isoton, a crystalloid infusion solution used as conventional fluid therapy.
Who can participate
The target population is patients with haemorrhagic shock who are treated in the emergency room. The source data do not give more detailed inclusion or exclusion rules, so the main known requirement is the presence of this emergency condition.
Haemorrhagic shock means the body has lost a large amount of blood and may not be getting enough blood flow to vital organs. This is a medical emergency, which is why the trial focuses on treatment started very early in care.
What is being measured
The brief summary says the study expects faster hemodynamic stabilization, which means better blood pressure and circulation stability. It also uses normalization of lactate levels to below 2 mmol/L as a surrogate parameter, meaning an indirect sign of recovery.
The trial also looks at whether HUMAN PLASMA can reduce the amount of crystalloid infusion solutions needed. The study team believes this may help avoid volume overload, which means too much fluid in the body.
The summary also states that lyophilized plasma may be faster to give than conventional plasma, with an application time of about 6.5 minutes versus about 30 to 45 minutes for conventional plasma. The trial uses this practical advantage as part of its research question in emergency treatment.
Why this trial matters
This study is important because haemorrhagic shock needs very fast treatment, and delays can be dangerous. The trial is designed to see whether a plasma-based approach can support quicker stabilization than standard fluid therapy.
For patients and families, the key point is that the research is not about long-term routine use, but about emergency care in a life-threatening situation. The goal is to find a better early treatment strategy for severe blood loss in the emergency room.