In breve
Clinical trials involving Human Plasma Protein are studying different patient groups, including children and adults with sepsis, scoliosis surgery, Alzheimer’s disease, and other conditions. These studies mainly look at safety, efficacy, and practical use in real treatment settings. The trials also measure outcomes such as blood loss, clotting, survival, and ability to follow the study plan.
Punti chiave
- Clinical trials involving Human Plasma Protein are being done in several different patient groups, including people with post-COVID POTS, sepsis, scoliosis surgery, early symptomatic Alzheimer’s disease, pediatric cardiac surgery, heart failure with preserved ejection fraction, and hemophilia. Most of the studies are Phase 2 or Phase 3, so they are testing the treatment in patients and measuring clinical results. The trials look at outcomes such as safety, survival, blood loss, clotting, and whether patients can follow the study plan. Some studies are completed, while others are still authorised. Overall, the data show a broad research program across both emergency care and chronic diseases.
Overview of the trials
The data include several interventional studies that investigate Human Plasma Protein directly or as part of plasma products used in patient care.
These studies are being done in different settings, from long-term diseases to urgent hospital care, and they focus on outcomes such as safety, blood clotting, blood loss, and survival.
Conditions being studied
The trials cover a wide range of conditions, including post-COVID-19 Postural Orthostatic Tachycardia Syndrome (POTS), sepsis, scoliosis surgery in children, early symptomatic Alzheimer’s disease, pediatric cardiac surgery, heart failure with preserved ejection fraction, and hemophilia A or B.
Some studies focus on emergency or hospital care, such as sepsis and surgery, while others look at chronic conditions like Alzheimer’s disease, HFpEF, and hemophilia.
Phases and participants
The studies are mostly in Phase 2 or Phase 3, which means they are testing the treatment in patients and collecting clinical results in larger groups.
The planned enrollment ranges from 47 participants in one study to 2000 in the sepsis trial, showing that some studies are small and focused while others are much larger.
One study is completed, while the others in the dataset are authorised.
Main outcomes being measured
The POTS study measures whether participants no longer meet the diagnostic criteria for post-COVID POTS during a standardized standing test, which checks the heart rate response when standing up.
The sepsis study uses two main outcomes: 28-day all-cause mortality and the number of days alive without life-supportive therapies, such as breathing support, medicines that raise blood pressure, or kidney replacement therapy.
The scoliosis surgery study measures intraoperative blood loss, meaning how much blood is lost during the operation after the wound is closed.
The Alzheimer’s disease study looks at adverse events after one year and how many participants follow the research protocol, which helps judge safety, tolerability, and feasibility.
The pediatric cardiac surgery study compares clotting variables after surgery, including protein C activity, protein S activity, antithrombin, plasminogen, fibrinogen, and tests such as ROTEM, aPTT, and PT.
The HFpEF study measures the change in VO2max, which is the maximum amount of oxygen the body can use during exercise, after continuous subcutaneous glucagon administration.
The hemophilia study focuses on the number of participants with treatment-emergent adverse events, which are side effects that appear during the study after treatment starts.
Key trial details
NCT06524739 is a double-blind, randomized, placebo-controlled Phase 3 study in adults with post-COVID POTS, with 177 planned participants. Its main goal is to test whether the study treatment helps more participants no longer meet the diagnostic criteria for POTS.
2025-521371-31-00 is a Phase 2 sepsis trial in children and adults, with 2000 planned participants, and it is designed to generate exploratory estimates of treatment effects on mortality and life-support needs at 28 days.
2024-514857-31-00 is a Phase 2 double-blind randomized trial in children undergoing instrumented spinal fusion for scoliosis, with 90 planned participants, and it compares OCTAPLAS with Plasma-Lyte for blood management.
NCT05068830 is a Phase 2 study in people with early symptomatic Alzheimer’s disease, with 60 planned participants, and it looks at safety, tolerability, and feasibility over one year.
2024-514073-22-01 is a Phase 3 study in pediatric congenital heart surgery, with 120 planned participants, and it compares clotting outcomes after fresh frozen plasma or Omniplasma use.
2025-521835-35-00 is a Phase 2 study in patients with HFpEF, with or without MASLD, and it measures exercise capacity through VO2max after continuous glucagon administration.
2023-508884-59-00 is a Phase 3 study in people with hemophilia A or B, with 281 planned participants, and it focuses on long-term safety and tolerability.
What this means for patients
These trials show that research involving Human Plasma Protein is being used in very different clinical situations, not just one disease area.
Across the studies, the main focus is on whether the treatment approach is safe, practical, and helpful for the target patient group.
Because the trials use different designs and endpoints, each study answers a specific research question for its own condition.