Haemorrhagic ShockC-TOPNCT06891131
Implementation of an Empiric Transfusion Bundle for Out of Hospital Patients With Haemorrhagic Shock
An observational study of Haemorrhagic Shock and Trauma Coagulopathy, run by Medical University of Graz at 1 site in Austria.
Trial summary
The investigators will evaluate the implementation of a treatment bundle (Fibrinogen, Plasma and Tranexamic Acid) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Haemorrhagic Shock, Trauma Coagulopathy
- How many people
- 10 participants
- Where
- 1 siteAustria
- Study dates
- 1 Jun 2025to 1 Jun 2027
- Phase
- Observational
- 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
Study population: Patients in haemorrhagic shock that are being treated by one of the prehospital emergency systems of the Medical University of Graz (HEMS, emergency car)
Who may be able to join
- aged, or believed to be aged
- 18 years or above
- confirmed or suspected life-threatening bleeding from trauma (i.e. signs of inadequate perfusion of tissues, tachycardia, hypotension, suspected blood loss)
- need for volume replacement therapy.
Who cannot join
- patient with known recent history of thromboembolic events within the last 6 months
- known or suspected pregnancy at presentation
- patient with known refusal of a participation in this clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Graz
Graz, 8043
Gabriel Honnef, MD, PhD, gabriel.honnef@medunigraz.at
About this study
Official title: Implementation of an Empiric Transfusion Bundle for Out of Hospital Patients With Haemorrhagic Shock: a Prospective Observational Study C-TOP - Coagulation Therapy for Out-of-Hospital Patients
The investigators will evaluate the implementation of a treatment bundle (Fibrinogen, Plasma and Tranexamic Acid)
Read the detailed description
The investigators will perform a prospective observational study of patients in haemorrhagic shock with suspected life threatening bleeding from trauma, treated by the prehospital emergency doctor response team of the Medical University of Graz and the HEMS (Helicopter Emergency Medical Service) of Graz according to their SOPs. Only patients that are being transported to the resuscitation room of the Medical University of Graz after prehospital transfusion will be included.
The SOPs for prehospital transfusion are being implemented for the treatment of patients in extremis because of suspected life-threatening traumatic bleeding in the above-mentioned emergency services, according to the manufacturer's requirements. These transfusion SOPs are already part of the standard of care in the resuscitation room of the Medical University of Graz.
This study seeks to gather information on the benefits and potential harms of this change of prehospital clinical routine.
The treatment bundle will include 2 units of Fibrinogen and Plasma in addition to 10-20 mg/kg Tranexamic Acid
- Conditions
- Haemorrhagic Shock, Trauma Coagulopathy
- Keywords
- Trauma, coagulopathy, haemmorhage, transfusion
- Medical subject headings
- Shock, Hemorrhagic, Wounds and Injuries, Hemostatic Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with successful prehospital bundle transfusion
to assess feasibility
Measured: prehospital setting
Secondary outcomes (3)
30-day-mortality
Measured: 30 days
blood product used in the first 24 hours
Measured: 24 hours
concentration of lactat acid ad admission
measured in the emergency department
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start1 Jun 2025
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Haemorrhagic ShockStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gabriel Honnef, MD, PhD, Principal investigator, Medical University of Graz, Department of Anaesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06891131
- Sponsor's protocol ID
- 1032/2025
- Acronym
- C-TOP
- Status last verified
- Mar 2025
- First submitted
- 17 Mar 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of an Empiric Transfusion Bundle for Out of Hospital Patients With Haemorrhagic Shock: a Prospective Observational Study C-TOP - Coagulation Therapy for Out-of-Hospital Patients
- ClinicalTrials.gov ID
- NCT06891131
- Acronym / sponsor ID
- C-TOP / 1032/2025
- Conditions
- Haemorrhagic Shock, Trauma Coagulopathy
- Keywords
- Trauma, coagulopathy, haemmorhage, transfusion
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 24 Mar 2025 (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.
The investigators will evaluate the implementation of a treatment bundle (Fibrinogen, Plasma and Tranexamic Acid)
Detailed description
The investigators will perform a prospective observational study of patients in haemorrhagic shock with suspected life threatening bleeding from trauma, treated by the prehospital emergency doctor response team of the Medical University of Graz and the HEMS (Helicopter Emergency Medical Service) of Graz according to their SOPs. Only patients that are being transported to the resuscitation room of the Medical University of Graz after prehospital transfusion will be included.
The SOPs for prehospital transfusion are being implemented for the treatment of patients in extremis because of suspected life-threatening traumatic bleeding in the above-mentioned emergency services, according to the manufacturer's requirements. These transfusion SOPs are already part of the standard of care in the resuscitation room of the Medical University of Graz.
This study seeks to gather information on the benefits and potential harms of this change of prehospital clinical routine.
The treatment bundle will include 2 units of Fibrinogen and Plasma in addition to 10-20 mg/kg Tranexamic Acid
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in haemorrhagic shock that are being treated by one of the prehospital emergency systems of the Medical University of Graz (HEMS, emergency car)
Key inclusion criteria (4 listed)
- aged, or believed to be aged
- 18 years or above
- confirmed or suspected life-threatening bleeding from trauma (i.e. signs of inadequate perfusion of tissues, tachycardia, hypotension, suspected blood loss)
- need for volume replacement therapy.
Key exclusion criteria (3 listed)
- patient with known recent history of thromboembolic events within the last 6 months
- known or suspected pregnancy at presentation
- patient with known refusal of a participation in this clinical trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients with successful prehospital bundle transfusion
Time frame: prehospital setting
to assess feasibility
3 secondary outcomes
30-day-mortality
Time frame: 30 days
blood product used in the first 24 hours
Time frame: 24 hours
concentration of lactat acid ad admission
Time frame: 2 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
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Enrolling by invitationObservational study
Cryo-FIRST: Effectiveness of INTERCEPT Fibrinogen Complex (IFC) for Trauma-Associated Hemorrhage
Hypofibrinogenemia, Hemorrhage
RecruitingPhase 4
The Safety of Simplified Tranexamic Acid Regimen
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RecruitingPhase 2
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Cytokine Release Syndrome, Recurrent Multiple Myeloma
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.
Gabriel Honnef, MD, PhD principal investigator
Medical University of Graz, Department of Anaesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Haemorrhagic Shock and Trauma Coagulopathy, run by Medical University of Graz at 1 site in Austria.
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 3 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: looking for participants now, as of the sponsor's last update on 17 Dec 2025. 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 Austria. 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?
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?
Contact Gabriel Honnef, MD, PhD (+436509160890, gabriel.honnef@medunigraz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with successful prehospital bundle transfusion (time frame: prehospital setting). 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 17 Dec 2025.