CoagulopathyPhase 2REPLaCENCT03981484
REPlaCE- Randomized Trial Evaluating the Use of Prothrombin Complex concEntrate to Improve Survival in Patients With Traumatic Coagulopathy
A Phase 2 study testing Prothrombin Complex Concentrate and Whole Blood, Plasma, Packed Red Blood Cells in people with Coagulopathy and Hemorrhage, run by Bellal A. Joseph, MD, FACS.
Trial summary
Uncontrolled hemorrhage continues to be a significant source of mortality for trauma patients. Their condition is further complicated by Trauma Induced Coagulopathy (TIC), which makes it more difficult to control bleeding due to coagulation factor deficiency. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Coagulopathy, Hemorrhage
- What is being tested?
- Prothrombin Complex Concentrate and Whole Blood, Plasma, Packed Red Blood Cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- No sites listed yet
- Study dates
- Jan 2020to Jan 2023
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ≥15 years old
- anticipate giving 4+ units based on Revised Assessment of Bleeding and Transfusion score ≥ 2
Who cannot join
- Cardiopulmonary Resuscitation > 5 minutes
- Penetrating cranial injury or exposed brain matter
- Anticoagulation treatment
- Transfer patients
- Known pregnancy
- Prisoners
Trial locations and contacts
No sites are listed yet.
About this study
Uncontrolled hemorrhage continues to be a significant source of mortality for trauma patients. Their condition is further complicated by Trauma Induced Coagulopathy (TIC), which makes it more difficult to control bleeding due to coagulation factor deficiency. Prothrombin Complex Concentrate (PCC) is thought to be a promising treatment option. This phase II clinical trial evaluates the use of 4-Factor PCC in addition to standard resuscitation methods compared to standard resuscitation methods alone in patients with TIC. Patients will be randomized at a 1:1 ratio. The primary endpoint of this trial will be 30 day mortality.
- Conditions
- Coagulopathy, Hemorrhage
- Being tested
- Prothrombin Complex Concentrate, Whole Blood, Plasma, Packed Red Blood Cells
- 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.
Prothrombin Complex ConcentrateBiological
single dose of 25 IU/kg of 4-PCC at time of enrollment
Whole Blood, Plasma, Packed Red Blood CellsBiological
site's standard resuscitation protocol
| Study group | Role | What they receive |
|---|---|---|
| PCC | Experimental | single dose of 4-Factor PCC in addition to standard resuscitation methods Receives: Biological: Prothrombin Complex Concentrate |
| Standard of Care | Active comparator | standard resuscitation methods only Receives: Biological: Whole Blood, Plasma, Packed Red Blood Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
24 Hour Mortality
Assess if patient is alive at 24 hours post treatment
Measured: 24 hours after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2019
- Study startJan 2020 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionJan 2023 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bellal A. Joseph, MD, FACS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bellal A. Joseph, MD, FACS, University of Arizona
- Investigators
- Bellal Joseph, MD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03981484
- Sponsor's protocol ID
- 00001
- Acronym
- REPLaCE
- Status last verified
- Jun 2019
- First submitted
- 6 Jun 2019
- Last updated
- 10 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REPlaCE- Randomized Trial Evaluating the Use of Prothrombin Complex concEntrate to Improve Survival in Patients With Traumatic Coagulopathy
- ClinicalTrials.gov ID
- NCT03981484
- Acronym / sponsor ID
- REPLaCE / 00001
- Conditions
- Coagulopathy, Hemorrhage
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Bellal A. Joseph, MD, FACSUniversity, hospital or other
- Study start
- Jan 2020 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 10 Jun 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.
Uncontrolled hemorrhage continues to be a significant source of mortality for trauma patients. Their condition is further complicated by Trauma Induced Coagulopathy (TIC), which makes it more difficult to control bleeding due to coagulation factor deficiency. Prothrombin Complex Concentrate (PCC) is thought to be a promising treatment option. This phase II clinical trial evaluates the use of 4-Factor PCC in addition to standard resuscitation methods compared to standard resuscitation methods alone in patients with TIC. Patients will be randomized at a 1:1 ratio. The primary endpoint of this trial will be 30 day mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCC | Experimental | Biological: Prothrombin Complex Concentratesingle dose of 4-Factor PCC in addition to standard resuscitation methods |
| Standard of Care | Active comparator | Biological: Whole Blood, Plasma, Packed Red Blood Cellsstandard resuscitation methods only |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- ≥15 years old
- anticipate giving 4+ units based on Revised Assessment of Bleeding and Transfusion score ≥ 2
Key exclusion criteria (6 listed)
- Cardiopulmonary Resuscitation > 5 minutes
- Penetrating cranial injury or exposed brain matter
- Anticoagulation treatment
- Transfer patients
- Known pregnancy
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 Concentratesingle dose of 25 IU/kg of 4-PCC at time of enrollment | Biological | PCC |
| Whole Blood, Plasma, Packed Red Blood Cellssite's standard resuscitation protocol | Biological | Standard of Care |
Primary outcome
24 Hour Mortality
Time frame: 24 hours after enrollment
Assess if patient is alive at 24 hours post treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2019.
- 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.
Bellal Joseph, MD principal investigator
University of Arizona
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Prothrombin Complex Concentrate and Whole Blood, Plasma, Packed Red Blood Cells in people with Coagulopathy and Hemorrhage, run by Bellal A. Joseph, MD, FACS.
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 2 inclusion and 6 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 10 Jun 2019. 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 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?
Contact Andrea Seach, BS (520-626-2876, aseach@surgery.arizona.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24 Hour Mortality (time frame: 24 hours after enrollment). 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 10 Jun 2019.