Trauma CoagulopathyPhase 4NCT06736860
Tranexamic Acid in Patients With Traumatic Bleeding Based on Dynamic Monitoring of Thromboelastography
A Phase 4 study testing Tranexamic acid (TXA) injection in people with Trauma Coagulopathy, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
Trauma is an important global public health problem and is the leading cause of death in people under 40 years old. Studies have shown that early prehospital administration of TXA 1 g intravenously followed by a continuous infusion of 1 g tranexamic acid (TXA) over 8 hours ( 1+1 regimen) is effective in reducing… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Trauma Coagulopathy
- What is being tested?
- Tranexamic acid (TXA) injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 580 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to 31 Dec 2028
- Phase
- Phase 4
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- . trauma patients 18 -80 years of age (50 points > trauma ISS score > 16);
- . hypotension (systolic blood pressure ≤ 90 mm Hg) and/or tachycardia (heart rate ≥ 110 beats/min);
- . receiving a 1 g TXA push within 3 h of the injury, with the push completed within 10 min of arrival at the hospital.
- . signing the informed consent form.
Who cannot join
- .Coagulation abnormalities due to co-morbid hematologic or autoimmune diseases
- Inability to establish venous or intraosseous access
- Pregnant women
- Traumatic cardiac arrest for more than 5 minutes
- Failure of cardiopulmonary resuscitation
- Penetrating brain injury
- Drowning or hanging -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
Xu Li Doctor Li, phD, +86 18680248866, mylx99@smu.edu.cn
About this study
Official title: Early and Precise Application and Evaluation of Tranexamic Acid in Patients With Traumatic Bleeding Based on Dynamic Monitoring of Thromboelastography
Trauma is an important global public health problem and is the leading cause of death in people under 40 years old. Studies have shown that early prehospital administration of TXA 1 g intravenously followed by a continuous infusion of 1 g tranexamic acid (TXA) over 8 hours ( 1+1 regimen) is effective in reducing mortality in trauma patients, but there is a residual risk of death. This clinical study utilized real-time dynamic monitoring of coagulation fibrinolytic status in trauma patients using thromboelastography (TEG) to assess the need for a second or even multiple administrations of TXA (1+X regimen) in addition to the administration of 1 g of TXA intravenously and to compare the two mortality rates, thus guiding the early and precise use of TXA in trauma patients to potentially reduce mortality in trauma patients while decreasing thromboembolic risk. The present study is an optimization and addition to the TXA 1+1 regimen. Currently, no relevant studies have been reported. This study has important clinical significance for standardizing the early and precise use of TXA in trauma patients and improving the effectiveness and safety of TXA.
Read the detailed description
Trauma, an important global public health problem, is the leading cause of death in people under 40 years of age. Post-traumatic hemorrhage deaths account for approximately half of the 4.6 million injury deaths worldwide each year . Their early deaths are due to severe hemorrhage and later to traumatic brain injury or secondary multi-organ dysfunction. Although resuscitation protocols for post-traumatic hemorrhage have improved over the past decade, shifting from massive rehydration aimed at perfusion to "damage control resuscitation" that prioritizes correction of early coagulation abnormalities, current transfusion therapies are still unable to correct coagulation during sustained bleeding. In recent years, the hemostatic drug therapy represented by Tranexamic Acid (TXA) has incorporated antifibrinolytic drugs into the global trauma practice guidelines . Overseas studies have shown that the use of TXA within 3 h after trauma can reduce the mortality rate due to trauma bleeding [5,6], but domestic clinical studies in this area are less reported, which is worthy of in-depth study.
The use of TEG for real-time dynamic monitoring of coagulation and fibrinolytic status in trauma patients to guide the early and precise application of TXA may be effective in reducing the mortality rate of severely traumatized patients, as well as reducing the occurrence of thromboembolism. Since the half-life of tranexamic acid is 1.8h , the present study is to use TEG to monitor the coagulation fibrinolytic status of traumatized patients in real time, and to assess the need for secondary or even multiple administrations of TXA (up to three times) (i.e., the 1+X regimen) after two half-life periods of TXA are about to be metabolized on the basis of the intravenous injection of 1g of TXA and to compare the two mortality rates, so that the early and precise use of TXA in traumatized patients can be guided, which may be effective in reducing the occurrence of thromboembolism. patients to guide the early and precise use of TXA in trauma patients, potentially reducing mortality in trauma patients while reducing the risk of thromboembolism. The present study is an optimization and addition to the TXA 1+1 regimen. Currently, there are no relevant literature reports and no references in relevant clinical trial registry websites. This study is clinically important for standardizing the early and precise use of TXA in trauma patients and improving the effectiveness and safety of TXA.
- Conditions
- Trauma Coagulopathy
- Being tested
- Tranexamic acid (TXA) injection
- Keywords
- Trauma Coagulopathy, tranexamic acid, Thromboelastography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acid (TXA) injectionDrug
All enrolled patients with acute trauma were given 1 g tranexamic acid (TXA) within 3 h after trauma, which was infused intravenously within 10 min, and randomized into groups. After admission, the first laboratory examination was conducted for both groups. The 1+1 control group continued to infuse 1g TXA within 8 h.
Tranexamic acid (TXA) injectionDrug
All enrolled patients with acute trauma were given 1 g tranexamic acid (TXA) within 3 h after trauma, which was infused intravenously within 10 min, and randomized into groups. After admission, the first laboratory examination was conducted for both groups. the 1+x study group was subjected to thromboelastography (TEG) without TXA for the time being, and the coagulation and fibrinolytic status of the patients was judged according to the results of TEG (LY30, EPL value), and the patients diagnosed with hyperfibrinolysis continued to be infused with 1g TXA, and the patients diagnosed with normal or reduced fibrinolysis were not infused with TXA. TEG was rechecked after 4 h, and the decision of whether to use TXA was based on the TEG results.
| Study group | Role | What they receive |
|---|---|---|
| 1+1 control group | Active comparator | Early prehospital administration of TXA 1 g intravenously followed by a continuous infusion of 1 g tranexamic acid (TXA) over 8 hours Receives: Drug: Tranexamic acid (TXA) injection |
| 1+X the case group | Experimental | Early prehospital administration of TXA 1 g , then using thromboelastography (TEG) to assess the need for a second or even multiple administrations of TXA ( 1+X regimen) in addition to the administration of 1 g of TXA intravenously Receives: Drug: Tranexamic acid (TXA) injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day all-cause mortality rate
Measured: 30-day
Secondary outcomes (4)
24-h and hospitalized mortality rates
Measured: Day1 and through study completion, an average of 7day
24 h of blood component transfusion
Measured: day1
Incidence of multi-organ failure
Measured: through study completion, an average of a week
Incidence of thrombotic events during hospitalization
Measured: through study completion, an average of a week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start1 Aug 2024
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 580 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06736860
- Sponsor's protocol ID
- NFEC-2024-615
- Status last verified
- Dec 2024
- First submitted
- 6 Dec 2024
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Because the data may be used for multiple analyses and article writing, the data will not be shared at this time.
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early and Precise Application and Evaluation of Tranexamic Acid in Patients With Traumatic Bleeding Based on Dynamic Monitoring of Thromboelastography
- ClinicalTrials.gov ID
- NCT06736860
- Acronym / sponsor ID
- NFEC-2024-615
- Conditions
- Trauma Coagulopathy
- Keywords
- Trauma Coagulopathy, tranexamic acid, Thromboelastography
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 580 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 17 Dec 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.
Trauma is an important global public health problem and is the leading cause of death in people under 40 years old. Studies have shown that early prehospital administration of TXA 1 g intravenously followed by a continuous infusion of 1 g tranexamic acid (TXA) over 8 hours ( 1+1 regimen) is effective in reducing mortality in trauma patients, but there is a residual risk of death. This clinical study utilized real-time dynamic monitoring of coagulation fibrinolytic status in trauma patients using thromboelastography (TEG) to assess the need for a second or even multiple administrations of TXA (1+X regimen) in addition to the administration of 1 g of TXA intravenously and to compare the two mortality rates, thus guiding the early and precise use of TXA in trauma patients to potentially reduce mortality in trauma patients while decreasing thromboembolic risk. The present study is an optimization and addition to the TXA 1+1 regimen. Currently, no relevant studies have been reported. This study has important clinical significance for standardizing the early and precise use of TXA in trauma patients and improving the effectiveness and safety of TXA.
Detailed description
Trauma, an important global public health problem, is the leading cause of death in people under 40 years of age. Post-traumatic hemorrhage deaths account for approximately half of the 4.6 million injury deaths worldwide each year . Their early deaths are due to severe hemorrhage and later to traumatic brain injury or secondary multi-organ dysfunction. Although resuscitation protocols for post-traumatic hemorrhage have improved over the past decade, shifting from massive rehydration aimed at perfusion to "damage control resuscitation" that prioritizes correction of early coagulation abnormalities, current transfusion therapies are still unable to correct coagulation during sustained bleeding. In recent years, the hemostatic drug therapy represented by Tranexamic Acid (TXA) has incorporated antifibrinolytic drugs into the global trauma practice guidelines . Overseas studies have shown that the use of TXA within 3 h after trauma can reduce the mortality rate due to trauma bleeding [5,6], but domestic clinical studies in this area are less reported, which is worthy of in-depth study.
The use of TEG for real-time dynamic monitoring of coagulation and fibrinolytic status in trauma patients to guide the early and precise application of TXA may be effective in reducing the mortality rate of severely traumatized patients, as well as reducing the occurrence of thromboembolism. Since the half-life of tranexamic acid is 1.8h , the present study is to use TEG to monitor the coagulation fibrinolytic status of traumatized patients in real time, and to assess the need for secondary or even multiple administrations of TXA (up to three times) (i.e., the 1+X regimen) after two half-life periods of TXA are about to be metabolized on the basis of the intravenous injection of 1g of TXA and to compare the two mortality rates, so that the early and precise use of TXA in traumatized patients can be guided, which may be effective in reducing the occurrence of thromboembolism. patients to guide the early and precise use of TXA in trauma patients, potentially reducing mortality in trauma patients while reducing the risk of thromboembolism. The present study is an optimization and addition to the TXA 1+1 regimen. Currently, there are no relevant literature reports and no references in relevant clinical trial registry websites. This study is clinically important for standardizing the early and precise use of TXA in trauma patients and improving the effectiveness and safety of TXA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1+1 control group | Active comparator | Drug: Tranexamic acid (TXA) injectionEarly prehospital administration of TXA 1 g intravenously followed by a continuous infusion of 1 g tranexamic acid (TXA) over 8 hours |
| 1+X the case group | Experimental | Drug: Tranexamic acid (TXA) injectionEarly prehospital administration of TXA 1 g , then using thromboelastography (TEG) to assess the need for a second or even multiple administrations of TXA ( 1+X regimen) in addition to the administration of 1 g of TXA intravenously |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- . trauma patients 18 -80 years of age (50 points > trauma ISS score > 16);
- . hypotension (systolic blood pressure ≤ 90 mm Hg) and/or tachycardia (heart rate ≥ 110 beats/min);
- . receiving a 1 g TXA push within 3 h of the injury, with the push completed within 10 min of arrival at the hospital.
- . signing the informed consent form.
Key exclusion criteria (7 listed)
- .Coagulation abnormalities due to co-morbid hematologic or autoimmune diseases
- Inability to establish venous or intraosseous access
- Pregnant women
- Traumatic cardiac arrest for more than 5 minutes
- Failure of cardiopulmonary resuscitation
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 |
|---|---|---|
| Tranexamic acid (TXA) injectionAll enrolled patients with acute trauma were given 1 g tranexamic acid (TXA) within 3 h after trauma, which was infused intravenously within 10 min, and randomized into groups. After admission, the first laboratory examination was conducted for both groups. The 1+1 control group continued to infuse 1g TXA within 8 h. | Drug | 1+1 control group |
| Tranexamic acid (TXA) injectionAll enrolled patients with acute trauma were given 1 g tranexamic acid (TXA) within 3 h after trauma, which was infused intravenously within 10 min, and randomized into groups. After admission, the first laboratory examination was conducted for both groups. the 1+x study group was subjected to thromboelastography (TEG) without TXA for the time being, and the coagulation and fibrinolytic status of the patients was judged according to the results of TEG (LY30, EPL value), and the patients diagnosed with hyperfibrinolysis continued to be infused with 1g TXA, and the patients diagnosed with normal or reduced fibrinolysis were not infused with TXA. TEG was rechecked after 4 h, and the decision of whether to use TXA was based on the TEG results. | Drug | 1+X the case group |
Primary outcome
30-day all-cause mortality rate
Time frame: 30-day
4 secondary outcomes
24-h and hospitalized mortality rates
Time frame: Day1 and through study completion, an average of 7day
24 h of blood component transfusion
Time frame: day1
Incidence of multi-organ failure
Time frame: through study completion, an average of a week
Incidence of thrombotic events during hospitalization
Time frame: through study completion, an average of a week
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 2024.
- Individual participant dataSharing planned: No. Because the data may be used for multiple analyses and article writing, the data will not be shared at this time.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tranexamic acid (TXA) injection in people with Trauma Coagulopathy, run by Nanfang Hospital, Southern Medical University 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 7 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 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Xu Li, doctor (+86 18680248866, mylx99@smu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day all-cause mortality rate (time frame: 30-day). 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 2024.