Traumatic BleedingNCT06627218
Liberal or Adhere to Recommendations for PCC Management in Major Bleeding Following Trauma
A study testing Prothrombin Complex Concentrate in people with Traumatic Bleeding, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Severe post-traumatic bleeding remains a major challenge in trauma management . The effectiveness and safety of PCC in the treatment of major traumatic bleeding is controversial, and the indications for use are not clear. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Traumatic Bleeding
- What is being tested?
- Prothrombin Complex Concentrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 650 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 Dec 2025
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old or < 80 years old
- Trauma treated in resuscitation unit/emergency room patient
- Hospital admission within 24h after injury
- Assessment of blood consumption (ABC) score ≥2 points.
Who cannot join
- PCC was used before admission
- Anticoagulant drugs (such as low molecular weight heparin, rivaroxaban, warfarin, etc.)
- Previous venous thrombosis (VTE, Patients with a history of coronary artery stents within 3 months of pulmonary embolism and myocardial infarction)
- Patients with traumatic cardiac arrest in hospital
- Women during breastfeeding, pregnancy or pregnancy
- Patients with hemophilia A and other blood system diseases, severe liver disease, cirrhosis and other coagulation dysfunction
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Emergency medicine, Second Affiliated Hospital, School of Medicine& Institute of Emergency medicine, Zhejiang University,
Hangzhou, Zhejiang, 310009
yongan xu, doctor, 13757164833, xuyongan2000@zju.edu.cn
About this study
Official title: Liberal or Adhere to Recommendations for Prothrombin Complex Concentrate Management in Major Bleeding Following Trauma：A Multicenter Retrospective Study
Severe post-traumatic bleeding remains a major challenge in trauma management . The effectiveness and safety of PCC in the treatment of major traumatic bleeding is controversial, and the indications for use are not clear. Studies on the status of PCC use and the efficacy evaluation of PCC adhere to recommendations are lacking.
Read the detailed description
Post-traumatic severe bleeding and associated traumatic coagulopathy remains a challenge.
The use of prothrombin complex concentrate (PCC) is being explored in the management of on-going coagulopathy following trauma, with the cited purpose of boosting thrombin generation. Clinical data on the efficacy of PCC as part of a coagulation factor concentrate-based haemostatic strategy showed initial promising results in retrospective studies and meta-analysis.
Certainly, the utility of PCC was a residual question in the management of traumatic coagulopathy. Uncertainty remains on the indication of use.The 2019 guideline on management of major bleeding and coagulopathy following trauma suggest that PCC should be administered to the bleeding patient based on evidence of delayed coagulation initiation using VEM, provided that fibrinogen levels are normal. The recommendation Grade is 2C.Studies on the status of PCC use and the efficacy evaluation of PCC adhere to recommendations are lacking.
- Conditions
- Traumatic Bleeding
- Being tested
- Prothrombin Complex Concentrate
- Keywords
- trauma, Major Bleeding
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prothrombin Complex ConcentrateDrug
Also called test group
Adhere to Recommendations for PCC Management in Major Bleeding Following Trauma
| Study group | Role | What they receive |
|---|---|---|
| Adhere to Recommendations for PCC Management | Experimental | Adhere to Recommendations for PCC Management in Major Bleeding Following Trauma Receives: Drug: Prothrombin Complex Concentrate |
| Liberal PCC Management | No intervention | Liberal PCC Management in Major Bleeding Following Trauma |
What is being measured
The primary outcome is the main question the study is designed to answer.
in-hospital mortality
in-hospital mortality
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start1 Jan 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic BleedingStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 650 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- yongan xu, doctor, Study chair, Department of Emergency medicine，Second Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06627218
- Sponsor's protocol ID
- 2021-0580
- Status last verified
- Sep 2024
- First submitted
- 2 Oct 2024
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liberal or Adhere to Recommendations for Prothrombin Complex Concentrate Management in Major Bleeding Following Trauma：A Multicenter Retrospective Study
- ClinicalTrials.gov ID
- NCT06627218
- Acronym / sponsor ID
- 2021-0580
- Conditions
- Traumatic Bleeding
- Keywords
- trauma, Major Bleeding
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 4 Oct 2024 (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.
Severe post-traumatic bleeding remains a major challenge in trauma management . The effectiveness and safety of PCC in the treatment of major traumatic bleeding is controversial, and the indications for use are not clear. Studies on the status of PCC use and the efficacy evaluation of PCC adhere to recommendations are lacking.
Detailed description
Post-traumatic severe bleeding and associated traumatic coagulopathy remains a challenge.
The use of prothrombin complex concentrate (PCC) is being explored in the management of on-going coagulopathy following trauma, with the cited purpose of boosting thrombin generation. Clinical data on the efficacy of PCC as part of a coagulation factor concentrate-based haemostatic strategy showed initial promising results in retrospective studies and meta-analysis.
Certainly, the utility of PCC was a residual question in the management of traumatic coagulopathy. Uncertainty remains on the indication of use.The 2019 guideline on management of major bleeding and coagulopathy following trauma suggest that PCC should be administered to the bleeding patient based on evidence of delayed coagulation initiation using VEM, provided that fibrinogen levels are normal. The recommendation Grade is 2C.Studies on the status of PCC use and the efficacy evaluation of PCC adhere to recommendations are lacking.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adhere to Recommendations for PCC Management | Experimental | Drug: Prothrombin Complex ConcentrateAdhere to Recommendations for PCC Management in Major Bleeding Following Trauma |
| Liberal PCC Management | No intervention | –Liberal PCC Management in Major Bleeding Following Trauma |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years old or < 80 years old
- Trauma treated in resuscitation unit/emergency room patient
- Hospital admission within 24h after injury
- Assessment of blood consumption (ABC) score ≥2 points.
Key exclusion criteria (6 listed)
- PCC was used before admission
- Anticoagulant drugs (such as low molecular weight heparin, rivaroxaban, warfarin, etc.)
- Previous venous thrombosis (VTE, Patients with a history of coronary artery stents within 3 months of pulmonary embolism and myocardial infarction)
- Patients with traumatic cardiac arrest in hospital
- Women during breastfeeding, pregnancy or 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 ConcentrateAlso: test groupAdhere to Recommendations for PCC Management in Major Bleeding Following Trauma | Drug | Adhere to Recommendations for PCC Management |
Primary outcome
in-hospital mortality
Time frame: 14 days
in-hospital mortality
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
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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.
yongan xu, doctor study chair
Department of Emergency medicine，Second Affiliated Hospital of Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prothrombin Complex Concentrate in people with Traumatic Bleeding, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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 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 4 Oct 2024. 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 China. 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.
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 yongan xu, doctor (13757164833, xuyongan2000@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
in-hospital mortality (time frame: 14 days). 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 4 Oct 2024.