CoagulopathyPhase 1NCT05629338
Ascending Dose Study of FrontlineODP™ Spray Dried Plasma
A Phase 1 study testing Autologous Spray Dried Plasma in people with Coagulopathy and Hemorrhage, run by Velico Medical at 3 sites in United States.
Trial summary
This study in healthy volunteers is designed to assess the safety of infusing increasing doses of spray dried plasma (FrontlineODP). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Coagulopathy, Hemorrhage
- What is being tested?
- Autologous Spray Dried Plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Dec 2022to 29 Apr 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and nonpregnant/nonbreastfeeding females
- For females, a minimum weight of 140 pounds and maximum weight of 220 pounds; for males, a minimum weight of 140 pounds and a maximum weight of 250 pounds
- Subject is 18 to 65 years of age, inclusive
- Subject self-reports that he or she feels well and healthy
- Subject scores ≥35 on the Duke Activity Status Index
- Subject is able to donate a unit of plasma by plasmapheresis based on the AABB Donor History Questionnaire with modifications indicated: subjects with history of travel, which puts them at risk for Creutzfeldt-Jakob Disease or malaria, are eligible to participate
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- Subject has completed a vaccination course for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), with the final vaccine injection administered at least 2 weeks before enrollment
- Subject has read the educational materials on donating blood and has had his or her questions answered
- Subject is able and willing to provide written informed consent
- Females of childbearing potential should either be surgically sterile (hysterectomy or tubal ligation) or should use a highly effective medically accepted contraceptive regimen. Highly effective methods of birth control are defined as those which result in a low failure rate (ie, less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices, sexual abstinence, condoms with spermicide, or vasectomized partner
- All females must have a negative urine or serum pregnancy test
- Subject understands the English language
Who cannot join
- Subject has known liver, kidney, cardiovascular, neurologic, gastrointestinal, blood, endocrine/metabolic, autoimmune, or pulmonary disease, or treated or untreated hypertension
- Subject has cancer of any kind, under treatment or resolved
- Subject has known or past coagulopathy conditions
- Subject has any conditions, uses medications, etc. on the AABB medical deferral list
- Subject has a history of asthma (defined as use of a prescribed daily asthma controller medication or required asthma medication in the past 2 weeks)
- Subject has a previous diagnosis of stroke, deep vein thrombosis (DVT), venous or arterial thrombosis, blood clots, or transient ischemic attack
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- Subject has a family history of venous or arterial thrombosis before the age of 50 years in first degree relatives (ie, biological parents, full siblings, or children)
- Subject has a D-dimer test result ≥0.5 FEU/mL
- Subject has a recent (within 1 year of Screening) history of an abnormal electrocardiogram of clinical significance as determined by the site PI
- Subject has known HIV or AIDS-related illness or received a positive test result for HIV infection
- Subject has a positive test result for HBV, hepatitis C virus (HCV), or human T-cell lymphotropic virus
- Subject has a history of significant treated or untreated mental health issues
- Subject is currently taking an antibiotic or another medication for an infection
- Subject has received aspirin or other platelet-inhibiting agents within 14 days of study donation and infusion visits. Prior and concomitant medication information will be recorded beginning 30 days before enrollment through the final follow-up visit
- Subject is currently using any medications for anticoagulant therapy
- Subject has used clotting factor concentrates(s) (eg, FVIIa)
- Subject has received blood or blood products within the past 12 months
- Subject has had concurrent headache and fever in the past week
- Subject has systolic blood pressure (current) greater than 140 mm Hg
- Subject has diastolic blood pressure (current) greater than 90 mm Hg
- Subject has an oral temperature greater than 100°F
- Subject has known hematocrit ≤39% for male donors and ≤38% for female donors
- Subject has a positive DAT result
- Subject has received any investigational agent within 1 month before treatment infusion for this study
- Subject is participating in any phase of any other investigational studies while participating in this study
- Subject is unwilling or unable to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's return for follow-up visits as scheduled
- Subject has other unspecified reasons that, in the opinion of the site PI, make the subject unsuitable for enrollment
- Subject is institutionalized because of legal or regulatory order
- Subject has a positive urine drug screen
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Hoxworth Blood Center
Cincinnati, Ohio, 45267-0055
Versiti Blood Center of Wisconsin
Milwaukee, Wisconsin, 53233
Spaulding Clinical Research LLC
West Bend, Wisconsin, 53095
About this study
Official title: Evaluation for the Safety of FrontlineODP™ in a Multidose Randomized Cohort Study Compared With PF24
This study in healthy volunteers is designed to assess the safety of infusing increasing doses of spray dried plasma (FrontlineODP).
Read the detailed description
This study in healthy volunteers is designed to assess the safety of infusing increasing doses of spray dried plasma (FrontlineODP). Volunteers will have their plasma collected, spray dried, and then rehydrated for infusion. Volunteers will be infused with their own (autologous) rehydrated plasma. Cohort 1 will receive 1 FrontlineODP unit that is rehydrated to approximately 200 mL. Cohort 2 will receive 2 FrontlineODP units of approximately 400 mL. Cohort 3 volunteers will receive 2 separate infusions of 4 units of approximately 800 mL of either FrontlineODP (experimental) or frozen plasma (PF24). Order of receipt of plasma product will be randomized with 14 days between infusion.
- Conditions
- Coagulopathy, Hemorrhage
- Being tested
- Autologous Spray Dried Plasma
- Keywords
- dried plasma, coagulation function, plasmapheresis
- Medical subject headings
- Hemostatic Disorders, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Spray Dried PlasmaCombination product
Also called FrontlineODP Unit, Frontline On Demand Plasma Unit
Evaluation of the Safety of Ascending Doses of Autologous Spray Dried Plasma in Healthy Volunteers
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Subjects are to have sufficient plasma withdrawn during a single plasmapheresis collection in the range of 625 - 800 mL, depending on subject's weight and hematocrit, to allow re-infusion with 1 unit (200 mL) of autologous FrontlineODP. Receives: Combination Product: Autologous Spray Dried Plasma |
| Cohort 2 | Experimental | Subjects are to have sufficient plasma withdrawn during a single plasmapheresis collection, in the range of 625 - 800 mL, depending on subject's weight and hematocrit, to allow re-infusion with 2 units (400 mL) of autologous FrontlineODP. Receives: Combination Product: Autologous Spray Dried Plasma |
| Cohort 3 Arm 3 | Active comparator | Subject plasma is withdrawn during 4 plasmapheresis collections, in the range of 625 - 800 mL per collection, a total of approximately 2500 - 3200 mL, depending on subject's weight and hematocrit, to allow re-infusion with 4 units of autologous FrontlineODP and 4 units of autologous control PF24. Subjects will receive in total 8 units of plasma over the course of 2 infusion visits. Subjects randomized to Arm 3 will receive 4 units of FrontlineODP during the first infusion visit, and following a 14 day washout period, they would receive 4 units of PF24 during a second visit. Receives: Combination Product: Autologous Spray Dried Plasma |
| Cohort 3 Arm 4 | Active comparator | Subject plasma is withdrawn during 4 plasmapheresis collections, in the range of 625 - 800 mL per collection, a total of approximately 2500 - 3200 mL, depending on subject's weight and hematocrit, to allow re-infusion with 4 units of autologous control PF24 and 4 units of autologous FrontlineODP. Subjects will receive in total 8 units of plasma over the course of 2 infusion visits. Subjects randomized to Arm 4 will receive 4 units of PF24 during the first infusion visit, and following a 14 day washout period, they would receive 4 units of FrontlineODP during the second visit. Receives: Combination Product: Autologous Spray Dried Plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Conclusions about safety will be based on the occurrence of TEAEs in Cohort 1 (1 unit of FrontlineODP, 200 mL) and Cohort 2 (2 units of FrontlineODP, 400 mL).
Measured: Start of plasma infusion through 28 day follow up (Day 29).
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Conclusions about safety will be based on the occurrence of TEAEs in Cohort 3 with infusions of 4 units (800 mL) of FrontlineODP compared to 4 units (800 mL) of PF24.
Measured: Start of first plasma infusion through 28 day follow up of the second infusion (Day 43).
Secondary outcomes (16)
Changes in PT
changes between pre-infusion baseline and 4 hours post-infusion values after infusion of 4 units of FrontlineODP compared with infusion of the same dose of PF24.
Measured: Start of first plasma infusion through 28-day follow up of second infusion (Day 43).
Changes in INR
changes between pre-infusion baseline and 4 hours post-infusion values after infusion of 4 units of FrontlineODP compared with infusion of the same dose of PF24.
Measured: Start of first plasma infusion through 28-day follow up of second infusion (Day 43).
Changes in aPTT
changes between pre-infusion baseline and 4 hours post-infusion values after infusion of 4 units of FrontlineODP compared with infusion of the same dose of PF24.
Measured: Start of first plasma infusion through 28-day follow up of second infusion (Day 43).
Changes in Factor I
changes between pre-infusion baseline and 4 hours post-infusion values after infusion of 4 units of FrontlineODP compared with infusion of the same dose of PF24.
Measured: Start of first plasma infusion through 28-day follow up of second infusion (Day 43).
Changes in Factor II
changes between pre-infusion baseline and 4 hours post-infusion values after infusion of 4 units of FrontlineODP compared with infusion of the same dose of PF24.
Measured: Start of first plasma infusion through 28-day follow up of second infusion (Day 43).
Changes in Factor V
changes between pre-infusion baseline and 4 hours post-infusion values after infusion of 4 units of FrontlineODP compared with infusion of the same dose of PF24.
Measured: Start of first plasma infusion through 28-day follow up of second infusion (Day 43).
Changes in Factor VII
changes between pre-infusion baseline and 4 hours post-infusion values after infusion of 4 units of FrontlineODP compared with infusion of the same dose of PF24.
Measured: Start of first plasma infusion through 28-day follow up of second infusion (Day 43).
Changes in Factor VIII
changes between pre-infusion baseline and 4 hours post-infusion values after infusion of 4 units of FrontlineODP compared with infusion of the same dose of PF24.
Measured: Start of first plasma infusion through 28-day follow up of second infusion (Day 43).
Changes in Factor IX
changes between pre-infusion baseline and 4 hours post-infusion values after infusion of 4 units of FrontlineODP compared with infusion of the same dose of PF24.
Measured: Start of first plasma infusion through 28-day follow up of second infusion (Day 43).
Changes in Factor X
changes between pre-infusion baseline and 4 hours post-infusion values after infusion of 4 units of FrontlineODP compared with infusion of the same dose of PF24.
Measured: Start of first plasma infusion through 28-day follow up of second infusion (Day 43).
Changes in Factor XI
changes between pre-infusion baseline and 4 hours post-infusion values after infusion of 4 units of FrontlineODP compared with infusion of the same dose of PF24.
Measured: Start of first plasma infusion through 28-day follow up of second infusion (Day 43).
Changes in D-dimer
changes between pre-infusion baseline and 4 hours post-infusion values after infusion of 4 units of FrontlineODP compared with infusion of the same dose of PF24.
Measured: Start of first plasma infusion through 28-day follow up of second infusion (Day 43).
Changes in von Willebrand Ristocetin Cofactor (vWF:RCo) activity
changes between pre-infusion baseline and 4 hours post-infusion values after infusion of 4 units of FrontlineODP compared with infusion of the same dose of PF24.
Measured: Start of first plasma infusion through 28-day follow up of second infusion (Day 43).
Changes in von Willebrand (vWF) antigen
changes between pre-infusion baseline and 4 hours post-infusion values after infusion of 4 units of FrontlineODP compared with infusion of the same dose of PF24.
Measured: Start of first plasma infusion through 28-day follow up of second infusion (Day 43).
Changes in protein S
changes between pre-infusion baseline and 4 hours post-infusion values after infusion of 4 units of FrontlineODP compared with infusion of the same dose of PF24.
Measured: Start of first plasma infusion through 28-day follow up of second infusion (Day 43).
Changes in protein C
changes between pre-infusion baseline and 4 hours post-infusion values after infusion of 4 units of FrontlineODP compared with infusion of the same dose of PF24.
Measured: Start of first plasma infusion through 28-day follow up of second infusion (Day 43).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start1 Dec 2022
- Primary completion18 Mar 2025
- Study completion29 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoagulopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study in healthy volunteers (n=24) is designed to assess the safety of infusing ascending doses of reconstituted autologous FrontlineODP in 1, 2, and 4 fixed-dose units. Subjects in Cohort 1 (n = 6) will receive 1 unit of FrontlineODP (Arm 1), which is approximately 200 mL. Subjects in Cohort 2 (n = 6) will receive 2 FrontlineODP units (Arm 2) (total volume of approximately 400 mL). Cohort 3 is a crossover design where subjects (n = 12) will be randomly assigned to receive either 4 units of FrontlineODP followed 14 days later by 4 units of PF24 (Arm 3 - ODPxPF24), or 4 units of PF24 followed 14 days later by 4 units of FrontlineODP (Arm 4 - PF24xODP), where each infusion has a total volume of approximately 800 mL.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Velico Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Popovsky, MD, Study director, Velico Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05629338
- Sponsor's protocol ID
- IDE 27346
- Status last verified
- Sep 2025
- First submitted
- 28 Oct 2022
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation for the Safety of FrontlineODP™ in a Multidose Randomized Cohort Study Compared With PF24
- ClinicalTrials.gov ID
- NCT05629338
- Acronym / sponsor ID
- IDE 27346
- Conditions
- Coagulopathy, Hemorrhage
- Keywords
- dried plasma, coagulation function, plasmapheresis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Velico MedicalIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 18 Mar 2025 (actual)
- Study completion
- 29 Apr 2025 (actual)
- First posted
- 29 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study in healthy volunteers is designed to assess the safety of infusing increasing doses of spray dried plasma (FrontlineODP).
Detailed description
This study in healthy volunteers is designed to assess the safety of infusing increasing doses of spray dried plasma (FrontlineODP). Volunteers will have their plasma collected, spray dried, and then rehydrated for infusion. Volunteers will be infused with their own (autologous) rehydrated plasma. Cohort 1 will receive 1 FrontlineODP unit that is rehydrated to approximately 200 mL. Cohort 2 will receive 2 FrontlineODP units of approximately 400 mL. Cohort 3 volunteers will receive 2 separate infusions of 4 units of approximately 800 mL of either FrontlineODP (experimental) or frozen plasma (PF24). Order of receipt of plasma product will be randomized with 14 days between infusion.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- This study in healthy volunteers (n=24) is designed to assess the safety of infusing ascending doses of reconstituted autologous FrontlineODP in 1, 2, and 4 fixed-dose units. Subjects in Cohort 1 (n = 6) will receive 1 unit of FrontlineODP (Arm 1), which is approximately 200 mL. Subjects in Cohort 2 (n = 6) will receive 2 FrontlineODP units (Arm 2) (total volume of approximately 400 mL). Cohort 3 is a crossover design where subjects (n = 12) will be randomly assigned to receive either 4 units of FrontlineODP followed 14 days later by 4 units of PF24 (Arm 3 - ODPxPF24), or 4 units of PF24 followed 14 days later by 4 units of FrontlineODP (Arm 4 - PF24xODP), where each infusion has a total volume of approximately 800 mL.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Combination Product: Autologous Spray Dried PlasmaSubjects are to have sufficient plasma withdrawn during a single plasmapheresis collection in the range of 625 - 800 mL, depending on subject's weight and hematocrit, to allow re-infusion with 1 unit (200 mL) of autologous FrontlineODP. |
| Cohort 2 | Experimental | Combination Product: Autologous Spray Dried PlasmaSubjects are to have sufficient plasma withdrawn during a single plasmapheresis collection, in the range of 625 - 800 mL, depending on subject's weight and hematocrit, to allow re-infusion with 2 units (400 mL) of autologous FrontlineODP. |
| Cohort 3 Arm 3 | Active comparator | Combination Product: Autologous Spray Dried PlasmaSubject plasma is withdrawn during 4 plasmapheresis collections, in the range of 625 - 800 mL per collection, a total of approximately 2500 - 3200 mL, depending on subject's weight and hematocrit, to allow re-infusion with 4 units of autologous FrontlineODP and 4 units of autologous control PF24. Subjects will receive in total 8 units of plasma over the course of 2 infusion visits. Subjects randomized to Arm 3 will receive 4 units of FrontlineODP during the first infusion visit, and following a 14 day washout period, they would receive 4 units of PF24 during a second visit. |
| Cohort 3 Arm 4 | Active comparator | Combination Product: Autologous Spray Dried PlasmaSubject plasma is withdrawn during 4 plasmapheresis collections, in the range of 625 - 800 mL per collection, a total of approximately 2500 - 3200 mL, depending on subject's weight and hematocrit, to allow re-infusion with 4 units of autologous control PF24 and 4 units of autologous FrontlineODP. Subjects will receive in total 8 units of plasma over the course of 2 infusion visits. Subjects randomized to Arm 4 will receive 4 units of PF24 during the first infusion visit, and following a 14 day washout period, they would receive 4 units of FrontlineODP during the second visit. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Males and nonpregnant/nonbreastfeeding females
- For females, a minimum weight of 140 pounds and maximum weight of 220 pounds; for males, a minimum weight of 140 pounds and a maximum weight of 250 pounds
- Subject is 18 to 65 years of age, inclusive
- Subject self-reports that he or she feels well and healthy
- Subject scores ≥35 on the Duke Activity Status Index
Key exclusion criteria (29 listed)
- Subject has known liver, kidney, cardiovascular, neurologic, gastrointestinal, blood, endocrine/metabolic, autoimmune, or pulmonary disease, or treated or untreated hypertension
- Subject has cancer of any kind, under treatment or resolved
- Subject has known or past coagulopathy conditions
- Subject has any conditions, uses medications, etc. on the AABB medical deferral list
- Subject has a history of asthma (defined as use of a prescribed daily asthma controller medication or required asthma medication in the past 2 weeks)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous Spray Dried PlasmaAlso: FrontlineODP Unit, Frontline On Demand Plasma UnitEvaluation of the Safety of Ascending Doses of Autologous Spray Dried Plasma in Healthy Volunteers | Combination product | Cohort 1, Cohort 2, Cohort 3 Arm 3, Cohort 3 Arm 4 |
Primary outcome
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Start of plasma infusion through 28 day follow up (Day 29).
Conclusions about safety will be based on the occurrence of TEAEs in Cohort 1 (1 unit of FrontlineODP, 200 mL) and Cohort 2 (2 units of FrontlineODP, 400 mL).
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Start of first plasma infusion through 28 day follow up of the second infusion (Day 43).
Conclusions about safety will be based on the occurrence of TEAEs in Cohort 3 with infusions of 4 units (800 mL) of FrontlineODP compared to 4 units (800 mL) of PF24.
16 secondary outcomes
Changes in PT
Time frame: Start of first plasma infusion through 28-day follow up of second infusion (Day 43).
Changes in INR
Time frame: Start of first plasma infusion through 28-day follow up of second infusion (Day 43).
Changes in aPTT
Time frame: Start of first plasma infusion through 28-day follow up of second infusion (Day 43).
Changes in Factor I
Time frame: Start of first plasma infusion through 28-day follow up of second infusion (Day 43).
Changes in Factor II
Time frame: Start of first plasma infusion through 28-day follow up of second infusion (Day 43).
Changes in Factor V
Time frame: Start of first plasma infusion through 28-day follow up of second infusion (Day 43).
Changes in Factor VII
Time frame: Start of first plasma infusion through 28-day follow up of second infusion (Day 43).
Changes in Factor VIII
Time frame: Start of first plasma infusion through 28-day follow up of second infusion (Day 43).
Changes in Factor IX
Time frame: Start of first plasma infusion through 28-day follow up of second infusion (Day 43).
Changes in Factor X
Time frame: Start of first plasma infusion through 28-day follow up of second infusion (Day 43).
Changes in Factor XI
Time frame: Start of first plasma infusion through 28-day follow up of second infusion (Day 43).
Changes in D-dimer
Time frame: Start of first plasma infusion through 28-day follow up of second infusion (Day 43).
Changes in von Willebrand Ristocetin Cofactor (vWF:RCo) activity
Time frame: Start of first plasma infusion through 28-day follow up of second infusion (Day 43).
Changes in von Willebrand (vWF) antigen
Time frame: Start of first plasma infusion through 28-day follow up of second infusion (Day 43).
Changes in protein S
Time frame: Start of first plasma infusion through 28-day follow up of second infusion (Day 43).
Changes in protein C
Time frame: Start of first plasma infusion through 28-day follow up of second infusion (Day 43).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Popovsky, MD study director
Velico Medical
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Autologous Spray Dried Plasma in people with Coagulopathy and Hemorrhage, run by Velico Medical at 3 sites in United States.
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 12 inclusion and 29 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: finished, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Occurrence of Treatment-Emergent Adverse Events (TEAEs) (time frame: Start of plasma infusion through 28 day follow up (Day 29).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Sep 2025.