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Thromboembolic EventPhase 4SAFE-PLASMANCT07840352

Safety And Field Evaluation of Plasma Lyophilized for Acute and Surgical Management Applications

A Phase 4 study testing Freeze-Dried Plasma and Conventional Plasma in people with Thromboembolic Event and FDP, run by Teleflex.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

The purpose of this study is to compare the safety of freeze-dried plasma (FDP), known as EZPLAZ, with conventional plasma in adults who need a plasma transfusion. Plasma is the liquid part of blood that contains proteins that help blood clot. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Thromboembolic Event, FDP
What is being tested?
Freeze-Dried Plasma and Conventional Plasma
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
867 participants
Where
No sites listed yet
Study dates
Oct 2027to May 2031
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Patients must be aged ≥ 18 years old and require plasma transfusion for one of the following indications:
  • Management of preoperative or bleeding patients who require replacement of multiple plasma coagulation factors (e.g., liver disease, disseminated intravascular coagulation [DIC])
  • Patients undergoing massive transfusion who have clinically significant coagulation deficiencies
  • Patients taking warfarin who are bleeding or need to undergo an invasive procedure before vitamin K could reverse the warfarin effect or who need only transient reversal of warfarin effect

Who cannot join

  • Patients aged < 18 years old
  • Receipt of any plasma product within 72 hours prior to the expected start of the index transfusion episode
  • Known intolerance to plasma or to any excipients (including citrate) in the investigational product (IP) formulation
  • Known history of any of the following:
  • Hypersensitivity reaction to plasma or plasma-derived products
  • Immunoglobulin A (IgA) deficiency with documented antibodies against IgA
Show all 22Show fewer
  • Congenital platelet disorder
  • Congenital or acquired thrombophilia
  • Extracorporeal membrane oxygenation (ECMO) therapy at the time of screening
  • Undergoing or may require therapeutic plasma exchange (TPE) for thrombotic thrombocytopenic purpura (TTP)
  • Prisoner
  • Adults under legal guardianship or state custody, as defined by applicable local regulations
  • Trauma patients with the following:
  • Traumatic cardiac arrest lasting > 5 minutes
  • Glasgow Coma Score (GCS) of ≤ 8, with an exception for drug-induced lowered GCS
  • Injury deemed nonsurvivable by trial team using established trauma assessment criteria
  • Injury Severity Score (ISS) of 75 (when available)
  • Known complete cervical spinal cord transection
  • Third-degree burns of > 20% total body surface area
  • Female patients who are pregnant
  • Current or planned participation in any phase of another investigational trial during participation in this trial
  • Patients who self-report previous enrollment in the SAFE-PLASMA trial at any participating medical center

About this study

Official title: A Phase 4, Cluster-Randomized Crossover, Prospective, Multi-Center Trial Evaluating the Safety of Freeze-Dried Plasma and Conventional Plasma Products in Adult Patients

The purpose of this study is to compare the safety of freeze-dried plasma (FDP), known as EZPLAZ, with conventional plasma in adults who need a plasma transfusion. Plasma is the liquid part of blood that contains proteins that help blood clot. The main question is whether the risk of blood clots or death within 7 days after the first transfusion is not unacceptably higher with FDP than with conventional plasma.

Participating hospitals will follow a randomly assigned schedule that determines which plasma product enrolled participants receive during each week. Participants will receive the product assigned to their hospital for that week during the first 24 hours of treatment. The treating physician will determine how much plasma is needed. After the first 24 hours, participants may receive either product if additional plasma is required.

Participants will be followed for 28 days after their first study transfusion. Information about blood clots, transfusion reactions, or other medical problems, and survival. Trial information will come from routine medical care and medical records. Follow-up after hospital discharge may include telephone contact with the participant or their legally authorized representative. No additional laboratory tests are required solely for this study.

Being tested
Freeze-Dried Plasma, Conventional Plasma
Keywords
freeze-dried plasma, lyophilized plasma, EZPLAZ, Plasma transfusion, conventional plasma, transfusion safety, cluster randomized trial, SAFE-PLASMA
Medical subject headings
Thromboembolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Freeze-Dried PlasmaBiological

    Also called EZPLAZ, FDP, Lyophilized plasma

    Single-donor human plasma supplied in freeze-dried form and reconstituted with sterile water before transfusion. Administered by intravenous or intraosseous infusion as prescribed by the treating physician and in accordance with institutional transfusion policies. Dose is determined by clinical need.

  • Conventional PlasmaBiological

    Also called FFP, PF24, PF24RT24

    Conventional plasma products selected, prepared, and administered according to each institution's standard of care. The protocol does not restrict the types of conventional plasma used. The treating physician determines the dose based on clinical need.

Study groups in NCT07840352
Study groupRoleWhat they receive
Freeze-Dried Plasma (FDP)ExperimentalParticipants enrolled during a center's assigned freeze-dried period receive EZPLAZ during the index transfusion episode, defined as the first 24 hours beginning with the first assigned plasma infusion. The treating physician determines the number of units required according to clinical need. After this period, either freeze-dried or conventional plasma may be administered if additional plasma is needed.
Receives: Biological: Freeze-Dried Plasma
Conventional PlasmaActive comparatorParticipants enrolled during a center's assigned conventional plasma period receive conventional plasma during the index transfusion episode, defined as the first 24 hours beginning with the first assigned plasma infusion. The treating physician determines the number of units required according to clinical need. After this period, either freeze-dried or conventional plasma may be administered if additional plasma is needed.
Receives: Biological: Conventional Plasma

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of participants with a thrombotic/thromboembolic event, or death

    Proportion of participants experiencing at least one thrombotic event, thromboembolic event, or death.

    Measured: Within 7 days after the start of plasma transfusion.

Secondary outcomes (14)

  1. Proportion of participants with serious adverse events

    Proportion of participants experiencing at least one serious adverse event, including acute and delayed reactions, evaluated at each specified time point.

    Measured: Within 24 hours, 7 days, and 28 days after plasma infusion

  2. Proportion of participants with treatment emergent adverse events

    Proportion of participants experiencing at least one treatment emergent adverse event

    Measured: Within 24 hours after the start of plasma infusion

  3. Proportion of participants with unexpected adverse events

    Proportion of participants experiencing at least one unexpected adverse event, as defined in the protocol

    Measured: Within 28 days after plasma infusion

  4. Proportion of participants with acute transfusion reactions

    Proportions of participants experiencing any acute transfusion reactions and bloodstream infection

    Measured: Within 24 hours post infusion

  5. Proportion of participants who die

    Proportion of participants who die after the start of the Index Transfusion Episode

    Measured: Within 6 hours and 24 hours after the start of the Index Transfusion Episode

  6. Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) levels

    AST and ALT values obtained during routine clinical care, when available, summarized by laboratory parameter and time point

    Measured: Pre-transfusion and 7 days post-transfusion

  7. Creatinine Levels

    Creatinine values obtained during routine clinical care, when available, summarized at each timepoint

    Measured: Pre-transfusion and 7 days post-transfusion

  8. Blood Urea Nitrogen (BUN)

    BUN values obtained during routine clinical care, when available, summarized at each time point.

    Measured: Pre-transfusion and 7 days post-transfusion

  9. Volume of Blood Components and Crystalloid Fluids Administered at infusion

    Total volume of each blood component and crystalloid fluid administered during the plasma infusion period, normalized by participant body weight

    Measured: From start to complete of plasma infusion

  10. Systolic and Diastolic Blood Pressure

    Change in blood pressure, summarized separately for systolic and diastolic measurements. Mean change from baseline is calculated when paired measurements are available

    Measured: Pre-infusion and 1-hour post-infusion

  11. Heart Rate

    Change in heart rate. Mean change from baseline is calculated when paired measurements are available, otherwise, mean observed values are reported.

    Measured: Pre-infusion and 1 hour post-infusion

  12. Respiratory Rate

    Change in respiratory rate. Mean change from baseline is calculated when paired measurements are available, otherwise, mean observed values are reported.

    Measured: Pre-infusion and 1 hour post-infusion

  13. Body Temperature

    Change in body temperature. Mean change from baseline is calculated when paired measurements are available, otherwise, mean observed values are reported.

    Measured: Pre-infusion and 1 hour post-infusion

  14. Oxygen Saturation

    Change in oxygen saturation. Mean change from baseline is calculated when paired measurements are available, otherwise, mean observed values are reported.

    Measured: Pre-infusion and 1 hour post-infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2026
  2. Study startOct 2027 (estimated)
  3. Primary completionApr 2031 (estimated)
  4. Study completionMay 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
Cluster-randomized crossover design. Each participating medical center follows a randomized sequence of weekly assignments to freeze-dried plasma or conventional plasma. Participants receive the product assigned to their center for the applicable week during their index transfusion episode. Individual participants are not separately randomized to a crossover sequence.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
867 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07840352
Sponsor's protocol ID
2026-01
Acronym
SAFE-PLASMA
Status last verified
Sep 2026
First submitted
18 Sep 2026
Last updated
30 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Freeze-Dried Plasma and Conventional Plasma in people with Thromboembolic Event and FDP, run by Teleflex.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants with a thrombotic/thromboembolic event, or death (time frame: Within 7 days after the start of plasma transfusion.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07840352.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.

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