Intracerebral HemorrhagePhase 2TRAIGENCT02625948
Tranexamic Acid for Acute ICH Growth prEdicted by Spot Sign
A Phase 2 study testing Tranexamic Acid in people with Intracerebral Hemorrhage and Stroke, run by Ministry of Science and Technology of the People´s Republic of China at 11 sites in China.
Trial summary
The purpose of this study is to determine if computed tomography angiography can predict which individuals with intracerebral hemorrhage will experience significant growth in the size of the hemorrhage. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Intracerebral Hemorrhage, Stroke
- What is being tested?
- Tranexamic Acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 11 sitesChina
- Study dates
- Sep 2015to Dec 2018
- 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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients presenting with an acute spontaneous hypertensive Intracerebral hemorrhage
- CTA evaluation can be accomplished within 6 hours of symptom onset, with "spot sign" positive in CTA original image
- Age range from 18 to 79 years
- Randomization can be finished and treatment can commence within 8 hours of symptom onset
- Informed consent has been received in accordance to local ethics committee requirements
Who cannot join
- ICH known or suspected to be secondary to tumour, vascular malformation, aneurysm or trauma
- Infratentorial ICH
- Glasgow coma scale (GCS) total score of <8
- ICH volume >70 ml
- Parenchymal hemorrhage with ventricle involved, blood completely fills one lateral ventricle or more than half of both lateral ventricles
- Contraindication of CTA imaging (e.g. known or suspected iodine allergy or significant renal failure)
Show all 12Show fewer
- Any history or current evidence suggestive of venous or arterial thrombotic events within the previous 6 months, including clinical, ECG, laboratory, or imaging findings. Clinically silent chance findings of old ischemia are not considered exclusion.
- Planned surgery for ICH
- Pregnancy or within 30 days after delivery, or during lactation
- Use of heparin, low-molecular weight heparin, or oral anticoagulation within the previous 1 week, with abnormal laboratory values
- Known allergy to tranexamic acid
- Prestroke modified mRS score of >2
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
China11 sites, 11 recruiting
- Not yet recruiting
Aviation General Hospital
Beijing, Beijing Municipality, 100050
- Recruiting
Beijing Fangshan District Liangxiang Hospital
Beijing, Beijing Municipality, 100050
- Recruiting
Beijing Friendship Hospital
Beijing, Beijing Municipality, 100050
- Recruiting
Beijing Haidian hospital
Beijing, Beijing Municipality, 100050
- Not yet recruiting
Beijing Huairou District Hospital
Beijing, Beijing Municipality, 100050
- Recruiting
Beijing Shunyi Hospital
Beijing, Beijing Municipality, 100050
- Recruiting
Beijing Tian Tan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
Liping Liu, MD, 8610-67098368
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100050
- Recruiting
Kailuan general hospital
Tangshan, Hebei, 063000
- Recruiting
Tangshan gongren hospital
Tangshan, Hebei, 063000
- Recruiting
Tangshan people's hospital
Tangshan, Hebei, 063000
About this study
The purpose of this study is to determine if computed tomography angiography can predict which individuals with intracerebral hemorrhage will experience significant growth in the size of the hemorrhage. For individuals who are at high risk for hemorrhage growth, the study will compare the drug Tranexamic acid to placebo to determine the effect and safety of on intracerebral hemorrhage growth
Read the detailed description
The Tranexamic Acid for Acute ICH Growth prEdicted by Spot Sign (TRAIGE) is a is a multicentre, randomized, placebo-controlled, double-blind, prospective, investigator-led, clinical trial of tranexamic acid within 6 hours of intracerebral hemorrhage in patients with contrast extravasation on CTA, 'the spot sign'. ICH patients within 6 hours of symptom onset, with the spot sign as a biomarker for ongoing hemorrhage, and no contraindications for antifibrinolytic therapy were enrolled in TRAIGE. The patient with a spot sign will be randomized to receive either the active treatment or placebo, the patient with no spot sign will be given regular treatment as observation. The trial is anticipated to complete in 36 months from the first subject recruitment , with 240 subjects recruited. A Data and Safety Monitoring Board (DSMB) will regularly monitor safety during the study. The trial has been approved by IRB(Institutional Review Board) /EC(Ethics Committee) in Beijing Tiantan hospital, Capital Medical University.
- Conditions
- Intracerebral Hemorrhage, Stroke
- Being tested
- Tranexamic Acid
- Keywords
- Intracerebral Hemorrhage, tranexamic acid, spot sign
- Medical subject headings
- Cerebral Hemorrhage, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
| Study group | Role | What they receive |
|---|---|---|
| tranexamic acid | Active comparator | tranexamic acid Receives: Drug: Tranexamic Acid |
| Placebo | Placebo comparator | 0.9% NaCl Receives: Drug: Tranexamic Acid |
| observation(spot sign -) | No intervention | regular clinical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
hemorrhage growth
either >33% or >6 ml increase from baseline, adjusted for baseline ICH volume
Measured: 24±2 hours
Secondary outcomes (5)
Major thromboembolic events
(1) acute myocardial ischemia; (2) acute cerebral ischemia; and (3) acute pulmonary embolism
Measured: 30±4 days
Poor clinical outcome
The Number of patients that is Death or major disability(mRS 4-6)
Measured: 90±7 days
short-term outcome
The Number of patients that with Modified Rankin Scale (mRS) 0-2 at 30±4 days
Measured: 30±4 days
Other thromboembolic events
Other thromboembolic events，such as venous thrombosis and other peripheral arterial embolism
Measured: 90±7 days
Death due to any cause
Number of patients that is Death due to any cause by 90±7 days
Measured: 90±7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2015 (estimated)
- Study startSep 2015
- Primary completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intracerebral HemorrhageStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ministry of Science and Technology of the People´s Republic of China
- Sponsor type
- Other government
- Collaborators
- Beijing Municipal Science & Technology Commission
- Responsible party
- Principal investigator, Liping Liu, Ministry of Science and Technology of the People´s Republic of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02625948
- Sponsor's protocol ID
- D141100000114002
- Acronym
- TRAIGE
- Status last verified
- Sep 2016
- First submitted
- 7 Dec 2015
- Last updated
- 14 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Eilertsen H, Menon CS, Law ZK, Chen C, Bath PM, Steiner T, Desborough MJ, Sandset EC, Sprigg N, Al-Shahi Salman R. Haemostatic therapies for stroke due to acute, spontaneous intracerebral haemorrhage. Cochrane Database Syst Rev. 2023 Oct 23;10(10):CD005951. doi: 10.1002/14651858.CD005951.pub5.
PubMed 37870112Fu F, Sun S, Liu L, Gu H, Su Y, Li Y. Iodine Sign as a Novel Predictor of Hematoma Expansion and Poor Outcomes in Primary Intracerebral Hemorrhage Patients. Stroke. 2018 Sep;49(9):2074-2080. doi: 10.1161/STROKEAHA.118.022017.
PubMed 30354984
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tranexamic Acid for Acute ICH Growth prEdicted by Spot Sign
- ClinicalTrials.gov ID
- NCT02625948
- Acronym / sponsor ID
- TRAIGE / D141100000114002
- Conditions
- Intracerebral Hemorrhage, Stroke
- Keywords
- Intracerebral Hemorrhage, tranexamic acid, spot sign
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Ministry of Science and Technology of the People´s Republic of ChinaOther government
- Collaborators
- Beijing Municipal Science & Technology Commission
- Study start
- Sep 2015
- Primary completion
- Dec 2018 (estimated)
- First posted
- 9 Dec 2015 (estimated)
- 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 purpose of this study is to determine if computed tomography angiography can predict which individuals with intracerebral hemorrhage will experience significant growth in the size of the hemorrhage. For individuals who are at high risk for hemorrhage growth, the study will compare the drug Tranexamic acid to placebo to determine the effect and safety of on intracerebral hemorrhage growth
Detailed description
The Tranexamic Acid for Acute ICH Growth prEdicted by Spot Sign (TRAIGE) is a is a multicentre, randomized, placebo-controlled, double-blind, prospective, investigator-led, clinical trial of tranexamic acid within 6 hours of intracerebral hemorrhage in patients with contrast extravasation on CTA, 'the spot sign'. ICH patients within 6 hours of symptom onset, with the spot sign as a biomarker for ongoing hemorrhage, and no contraindications for antifibrinolytic therapy were enrolled in TRAIGE. The patient with a spot sign will be randomized to receive either the active treatment or placebo, the patient with no spot sign will be given regular treatment as observation. The trial is anticipated to complete in 36 months from the first subject recruitment , with 240 subjects recruited. A Data and Safety Monitoring Board (DSMB) will regularly monitor safety during the study. The trial has been approved by IRB(Institutional Review Board) /EC(Ethics Committee) in Beijing Tiantan hospital, Capital Medical University.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| tranexamic acid | Active comparator | Drug: Tranexamic Acidtranexamic acid |
| Placebo | Placebo comparator | Drug: Tranexamic Acid0.9% NaCl |
| observation(spot sign -) | No intervention | –regular clinical treatment |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients presenting with an acute spontaneous hypertensive Intracerebral hemorrhage
- CTA evaluation can be accomplished within 6 hours of symptom onset, with "spot sign" positive in CTA original image
- Age range from 18 to 79 years
- Randomization can be finished and treatment can commence within 8 hours of symptom onset
- Informed consent has been received in accordance to local ethics committee requirements
Key exclusion criteria (12 listed)
- ICH known or suspected to be secondary to tumour, vascular malformation, aneurysm or trauma
- Infratentorial ICH
- Glasgow coma scale (GCS) total score of <8
- ICH volume >70 ml
- Parenchymal hemorrhage with ventricle involved, blood completely fills one lateral ventricle or more than half of both lateral ventricles
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 | Drug | Placebo, tranexamic acid |
Primary outcome
hemorrhage growth
Time frame: 24±2 hours
either >33% or >6 ml increase from baseline, adjusted for baseline ICH volume
5 secondary outcomes
Major thromboembolic events
Time frame: 30±4 days
Poor clinical outcome
Time frame: 90±7 days
short-term outcome
Time frame: 30±4 days
Other thromboembolic events
Time frame: 90±7 days
Death due to any cause
Time frame: 90±7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2016.
- Derived from this study: PubMed 37870112Eilertsen H, Menon CS, Law ZK, Chen C, Bath PM, Steiner T, Desborough MJ, Sandset EC, Sprigg N, Al-Shahi Salman R. Haemostatic therapies for stroke due to acute, spontaneous intracerebral haemorrhage. Cochrane Database Syst Rev. 2023 Oct 23;10(10):CD005951. doi: 10.1002/14651858.CD005951.pub5.
- Derived from this study: PubMed 30354984Fu F, Sun S, Liu L, Gu H, Su Y, Li Y. Iodine Sign as a Novel Predictor of Hematoma Expansion and Poor Outcomes in Primary Intracerebral Hemorrhage Patients. Stroke. 2018 Sep;49(9):2074-2080. doi: 10.1161/STROKEAHA.118.022017.
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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.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tranexamic Acid in people with Intracerebral Hemorrhage and Stroke, run by Ministry of Science and Technology of the People´s Republic of China at 11 sites 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 5 inclusion and 12 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 14 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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. 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?
Contact Liping Liu, MD (8610-67098368, lipingsister@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hemorrhage growth (time frame: 24±2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02625948, which also lists 2 linked publications.
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 14 Sep 2016.