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Study of Lyophilized Plasma Compared to Standard Fluid Solutions for Patients with Hemorrhagic Shock in the Emergency Room

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is looking at patients who have hemorrhagic shock, which is a serious condition that happens when a person loses a large amount of blood. When someone is in hemorrhagic shock, their blood pressure drops very low and their body cannot get enough oxygen to the organs, which can be life-threatening. The study will test two different types of fluids that doctors give to these patients through a vein. One treatment is called LyoPlas N-W, which is a special form of human plasma that has been freeze-dried and can be prepared very quickly for use. The other treatment is ELO-MEL isoton, which is a standard fluid solution containing salts and minerals such as sodium chloride, potassium chloride, magnesium chloride hexahydrate, calcium chloride dihydrate, and sodium acetate trihydrate that doctors commonly use to replace lost fluids.

The purpose of this study is to find out whether giving freeze-dried plasma early in the emergency room works better than giving the standard salt solution to patients in hemorrhagic shock. The researchers believe that the freeze-dried plasma might help patients recover faster because it can be prepared and given much more quickly than regular plasma, it may help protect the blood vessels, and it stays in the bloodstream longer. They will measure how quickly patients improve by checking the level of a substance called lactate in the blood, which goes up when the body is not getting enough oxygen. The study will also look at whether using freeze-dried plasma means that patients need less of the salt solution, which could help avoid problems that sometimes happen when too much fluid is given.

During the study, patients who come to the emergency room with hemorrhagic shock will receive either the freeze-dried plasma or the standard salt solution through an infusion into their vein. The doctors will monitor how the patients respond to the treatment and will measure various signs of recovery. The study will compare the two treatments to see which one helps patients stabilize more quickly and which one leads to better outcomes overall.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment and enrollment
Your condition will be assessed upon arrival at the emergency room. If you are experiencing hemorrhagic shock (a serious condition caused by significant blood loss), you may be eligible for this trial.
The diagnosis of hemorrhagic shock in this study is based on three criteria: obvious or suspected blood loss, low blood pressure (systolic blood pressure at or below 90 mmHg) or the need for medications to maintain blood pressure, and elevated lactate levels in your blood (at or above 2 mmol/L). Lactate is a substance that increases in your blood when your body tissues are not receiving enough oxygen.
You must be 18 years of age or older to participate in this trial.
Step 2
Treatment assignment
You will be assigned to receive one of two treatment options as part of this study.
The first option is lyophilized plasma (LyoPlas N-W), which is a freeze-dried form of human plasma that can be prepared and administered quickly. This treatment is given through infusion (directly into your vein) and typically takes approximately 6.5 minutes to administer.
The second option is a conventional crystalloid infusion solution (ELO-MEL isoton), which contains electrolytes including magnesium chloride hexahydrate, potassium chloride, sodium chloride, calcium chloride dihydrate, and sodium acetate trihydrate. This solution is also given through infusion into your vein.
Step 3
Treatment administration
The assigned treatment will be administered to you in the emergency room.
If you receive lyophilized plasma, the infusion will be completed in approximately 6.5 minutes.
If you receive the crystalloid solution, the infusion duration may vary based on your medical needs.
Both treatments are administered through intravenous infusion, meaning the solution will be delivered directly into one of your veins.
Step 4
Monitoring and assessment
Your blood pressure and overall condition will be monitored throughout the treatment.
Blood samples will be taken to measure your lactate levels. The goal is to normalize these levels to below 2 mmol/L, which indicates improved oxygen delivery to your body tissues.
Your healthcare team will also assess how quickly your blood pressure stabilizes and how much fluid is needed to maintain your condition.
The amount of crystalloid infusion solution required will be recorded, as one aim of the study is to determine whether lyophilized plasma reduces the need for these additional fluids.
Step 5
Ongoing care and observation
You will continue to receive standard medical care for hemorrhagic shock according to your clinical needs.
Your response to the treatment will be evaluated through continued monitoring of your vital signs and laboratory values.
Any additional treatments or interventions required for your condition will be provided as necessary.

Who can join the trial?

5 criteria

You must be 18 years of age or older
You must be experiencing or about to experience hemorrhagic shock, which is a serious condition where your body loses a large amount of blood
You must have obvious or suspected blood loss, meaning bleeding that can be seen or is strongly thought to be happening inside your body
Your systolic blood pressure must be 90 mmHg or lower, or you need medicines called vasopressors to keep your blood pressure at a safe level. Systolic blood pressure is the top number when your blood pressure is measured and shows the pressure in your blood vessels when your heart beats
Your blood must show a lactate level of 2 mmol/L or higher. Lactate is a substance that builds up in your blood when your body tissues are not getting enough oxygen due to poor blood flow

Who cannot join the trial?

1 criterion

No exclusion criteria have been specified for this clinical trial

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Johannes Kepler University
Linz, Austria

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Investigated drugs

Lyophilized plasma
is a freeze-dried form of blood plasma that can be quickly prepared and given to patients. Plasma is the liquid part of blood that contains important proteins and clotting factors. In this trial, lyophilized plasma is being tested to see if it can help stabilize patients who are in shock from severe bleeding. It can be prepared much faster than regular plasma and may help the body maintain blood pressure and reduce bleeding more effectively.
Crystalloid infusion solutions
are sterile salt-water solutions that are commonly given through an IV to replace lost fluids in the body. These solutions help maintain blood pressure and keep organs functioning when a patient has lost blood. In this trial, they represent the standard treatment that is being compared to lyophilized plasma.

What is already known about the treatment

Lyophilized Plasma – Lyophilized plasma is a freeze-dried form of blood plasma that can be quickly prepared and given to patients through intravenous infusion, typically reconstituted with sterile water in about 6.5 minutes. It is currently being studied in clinical trials as an emergency treatment for patients experiencing hemorrhagic shock, which is a life-threatening condition caused by severe blood loss. This medication works by helping to stabilize blood pressure and restore blood volume more effectively than standard salt-water solutions, while also supporting the inner lining of blood vessels and maintaining better fluid balance in the body. Lyophilized plasma belongs to the pharmacological class of blood products and volume expanders used in resuscitation therapy.

Investigated diseases

Hemorrhagic Shock – Hemorrhagic shock is a life-threatening condition that occurs when the body loses a large amount of blood, typically more than 20% of total blood volume. This blood loss can result from severe injuries, internal bleeding, or surgical complications. As blood volume decreases, the heart cannot pump enough blood to supply oxygen and nutrients to vital organs and tissues. The body initially tries to compensate by increasing heart rate and narrowing blood vessels, but as bleeding continues, blood pressure drops significantly. Without adequate blood flow, organs begin to malfunction and cells start to suffer from lack of oxygen. The condition progresses through stages of increasing severity, with symptoms including rapid heartbeat, weak pulse, cold and pale skin, confusion, and decreased urine output.