Trauma InjuryPhase 2NCT04019015
Prehospital Kcentra for Hemorrhagic Shock
A Phase 2 study testing Prothrombin Complex Concentrate, Human in people with Trauma Injury, run by Oregon Health and Science University at 1 site in United States.
Trial summary
This is a pilot trial being performed to evaluate the feasibility, to include the ability of EMS to identify patients in shock and the ability to package, store, and administer Kcentra in the field. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma Injury
- What is being tested?
- Prothrombin Complex Concentrate, Human
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 166 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2021to 31 Mar 2025
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Trauma patients age 18 years or greater, or weight > 50 kg if age unknown
- Systolic blood pressure < 70 mmHg
- Suspicion of hemorrhagic shock based on mechanism of injury
- EMS transport to a participating trauma center
Who cannot join
- Age less than 18
- Unknown time of injury
- Out-of-hospital cardiopulmonary resuscitation
- Known history of thromboembolic disorders or stroke or suspicion by EMS of a recent stroke
- Known oral anti-coagulant use to include warfarin and novel anti-coagulants
- Severe hypothermia (<28°C)
Show all 19Show fewer
- Drowning or asphyxia due to hanging
- Burns more than 20% total body surface area
- Evidence of devastating blunt traumatic brain injury to include fixed and dilated pupils, asymmetric pupils and extrusion of brain matter
- Isolated blunt or penetrating head injury
- Isolated spinal cord injury
- Ground level (same level) falls
- Inability to obtain intravenous access
- Inability to administer randomized therapy within 4 hours of ambulance notification
- Known transfers and inter-facility transfers
- Known Do Not Resuscitate (DNR) prior to randomization
- Known or suspected pregnancy
- Known prisoners
- Patients who have activated the "opt-out" process
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: A Prospective Randomized Prehospital Trial Comparing Kcentra Plus Standard of Care to Standard of Care Alone in Trauma Patient With Hemorrhagic Shock
This is a pilot trial being performed to evaluate the feasibility, to include the ability of EMS to identify patients in shock and the ability to package, store, and administer Kcentra in the field.
Read the detailed description
Prospective randomized trials have shown that 4-factor prothrombin complex concentrate (4FPCCs) result in more rapid correction of coagulopathy and greater likelihood of achieving hemostasis in patients receiving vitamin K antagonists who require emergent operations or who are bleeding. 4FPCCs have not been studied in the pre-hospital setting as a primary resuscitative adjunct. The investigators believe the effects of Kcentra to prevent or treat coagulopathy early after injury combined with its ability to treat the endotheliopathy of trauma and prevent organ failure will results in improved outcomes in severely injured trauma patients with hemorrhagic shock. The investigators have chosen to study a population of trauma patients in severe hemorrhagic shock (SBP < 70mmHg) because this population is at greatest risk for developing acute coagulopathy of trauma and has the greatest potential to benefit from the proposed therapy.
- Conditions
- Trauma Injury
- Being tested
- Prothrombin Complex Concentrate, Human, Placebo
- Keywords
- Shock, Hemorrhagic, Trauma, Mortality, Wounds and Injuries, Hemorrhage
- Medical subject headings
- Accidental Injuries, Shock, Hemorrhagic, Wounds and Injuries, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prothrombin Complex Concentrate, HumanDrug
Also called Kcentra
Prothrombin Complex Concentrate (PCC) prepared from human plasma and contains blood coagulation factors
PlaceboDrug
Normal saline solution
| Study group | Role | What they receive |
|---|---|---|
| Kcentra | Experimental | A single dose of Kcentra based on estimated body weight
* 2000 U for patients with an estimated body weight ≤ 75kg
* 3000 U for patients with an estimated body weight > 75kg Receives: Drug: Prothrombin Complex Concentrate, Human |
| Placebo | Placebo comparator | A single infusion of volume matched placebo solution (Normal Saline) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of study drug administration
Number of study drug kits opened and given to patients prior to hospital arrival.
Measured: First 24 hours after injury
Secondary outcomes (5)
Mortality
To evaluate mortality at 3 hour, 24 hour, and 30 days
Measured: First 30 days after injury
Hospital Free Days
Number of days out of the hospital
Measured: First 30 days after injury
ICU Free Days
Number of days out of the ICU
Measured: First 30 days after injury
Ventilator Free Days
Number of days not on a ventilator
Measured: First 30 days after injury
Blood Transfusions
The amount of blood products transfused in the first 24 hours
Measured: First 24 hours after injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2019
- Study start15 Mar 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma InjuryStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin A Schreiber, MD, Oregon Health and Science University
- Investigators
- Martin A Schreiber, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04019015
- Sponsor's protocol ID
- OHSU IRB 17077
- Status last verified
- Dec 2023
- First submitted
- 2 Jun 2019
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Prehospital Trial Comparing Kcentra Plus Standard of Care to Standard of Care Alone in Trauma Patient With Hemorrhagic Shock
- ClinicalTrials.gov ID
- NCT04019015
- Acronym / sponsor ID
- OHSU IRB 17077
- Conditions
- Trauma Injury
- Keywords
- Shock, Hemorrhagic, Trauma, Mortality, Wounds and Injuries, Hemorrhage
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 166 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 15 Jul 2019 (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 is a pilot trial being performed to evaluate the feasibility, to include the ability of EMS to identify patients in shock and the ability to package, store, and administer Kcentra in the field.
Detailed description
Prospective randomized trials have shown that 4-factor prothrombin complex concentrate (4FPCCs) result in more rapid correction of coagulopathy and greater likelihood of achieving hemostasis in patients receiving vitamin K antagonists who require emergent operations or who are bleeding. 4FPCCs have not been studied in the pre-hospital setting as a primary resuscitative adjunct. The investigators believe the effects of Kcentra to prevent or treat coagulopathy early after injury combined with its ability to treat the endotheliopathy of trauma and prevent organ failure will results in improved outcomes in severely injured trauma patients with hemorrhagic shock. The investigators have chosen to study a population of trauma patients in severe hemorrhagic shock (SBP < 70mmHg) because this population is at greatest risk for developing acute coagulopathy of trauma and has the greatest potential to benefit from the proposed therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kcentra | Experimental | Drug: Prothrombin Complex Concentrate, HumanA single dose of Kcentra based on estimated body weight * 2000 U for patients with an estimated body weight ≤ 75kg * 3000 U for patients with an estimated body weight > 75kg |
| Placebo | Placebo comparator | Drug: PlaceboA single infusion of volume matched placebo solution (Normal Saline) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Trauma patients age 18 years or greater, or weight > 50 kg if age unknown
- Systolic blood pressure < 70 mmHg
- Suspicion of hemorrhagic shock based on mechanism of injury
- EMS transport to a participating trauma center
Key exclusion criteria (19 listed)
- Age less than 18
- Unknown time of injury
- Out-of-hospital cardiopulmonary resuscitation
- Known history of thromboembolic disorders or stroke or suspicion by EMS of a recent stroke
- Known oral anti-coagulant use to include warfarin and novel anti-coagulants
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 |
|---|---|---|
| Prothrombin Complex Concentrate, HumanAlso: KcentraProthrombin Complex Concentrate (PCC) prepared from human plasma and contains blood coagulation factors | Drug | Kcentra |
| PlaceboNormal saline solution | Drug | Placebo |
Primary outcome
Feasibility of study drug administration
Time frame: First 24 hours after injury
Number of study drug kits opened and given to patients prior to hospital arrival.
5 secondary outcomes
Mortality
Time frame: First 30 days after injury
Hospital Free Days
Time frame: First 30 days after injury
ICU Free Days
Time frame: First 30 days after injury
Ventilator Free Days
Time frame: First 30 days after injury
Blood Transfusions
Time frame: First 24 hours after injury
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
- 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.
Martin A Schreiber, MD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Prothrombin Complex Concentrate, Human in people with Trauma Injury, run by Oregon Health and Science University at 1 site 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 4 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Feasibility of study drug administration (time frame: First 24 hours after injury). 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 15 Dec 2023.