Subarachnoid HemorrhagePhase 2/3ULTRANCT02684812
Ultra-early Tranexamic Acid After Subarachnoid Hemorrhage.
A Phase 2/3 study testing Tranexamic Acid in people with Subarachnoid Hemorrhage, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
This is a multicenter, prospective, randomized, open-label trial with blinded endpoint (PROBE) assessment. Adult patients with the diagnosis of non-traumatic SAH, as proven by computed tomography (CT) within 24 hours after the onset of headache, will be randomly assigned to the treatment group or the control group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subarachnoid Hemorrhage
- What is being tested?
- Tranexamic Acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 955 participants
- Where
- 1 siteNetherlands
- Study dates
- 16 Jul 2012to 1 Nov 2020
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admission to one of the study centers or their referring hospitals
- CT-confirmed SAH with most recent ictus less than 24 hours ago Definition: subarachnoid hemorrhage is a bleeding pattern on computed tomography with hyperdensity in the basal cisterns and/or Sylvian or interhemipheric fissures or a intraparenchymal hyperdensity consistent with a hematoma from an anterior, a pericallosal, a posterior or a middle cerebral artery aneurysm.
Who cannot join
- No proficiency of the Dutch or English language
- No loss of consciousness after the hemorrhage with WFNS grade 1 or 2 on admission in combination with a perimesencephalic hemorrhage Definition: on CT examination presence of hyperdensities exclusively in the basal cisterns maximal extending to the proximal part of the Sylvian fissure or posterior part of the interhemispheric fissure, without evidence for intracerebral or intraventricular haemorrhage (except slight sedimentation)
- Bleeding pattern on CT compatible with a traumatic SAH
- Treatment for deep vein thrombosis or pulmonary embolism
- History of a blood coagulation disorder (a hypercoagulability disorder)
- Pregnancy checked with a pregnancy test in women in their childbearing period
Show all 9Show fewer
- History of severe renal (serum creatinin >150 mmol/L)
- History of severe liver failure (AST > 150 U/l or ALT > 150 U/l or AF > 150 U/l or γ-GT > 150 U/l)
- Imminent death within 24 hours
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultra-early Tranexamic Acid After Subarachnoid Hemorrhage. A Prospective, Randomized, Multicenter Study.
This is a multicenter, prospective, randomized, open-label trial with blinded endpoint (PROBE) assessment. Adult patients with the diagnosis of non-traumatic SAH, as proven by computed tomography (CT) within 24 hours after the onset of headache, will be randomly assigned to the treatment group or the control group. Patients in the treatment group will receive standard treatment with the addition of a bolus of TXA (1 g intravenously) immediately after randomization, followed by continuous infusion of 1 g per 8 hours until the start of aneurysm treatment, or a maximum of 24 hours after the start of medication. Patients in the control group will receive standard treatment without TXA. The primary outcome measure is favorable functional outcome, defined as a score of 0 to 3 on the modified Rankin Scale (mRS), at 6 months after SAH. Primary outcome will be determined by a trial nurse blinded for treatment allocation.
Read the detailed description
Approximately 50% of all patients with a subarachnoid hemorrhage (SAH) die due to the hemorrhage or subsequent complications. There are several major causes for this course, such as in-hospital rebleed in 21.5% which most frequently occurs within the first 6 hours after the primary hemorrhage ("ultra-early rebleed"). A major part of the patients with a rebleed die during hospital admission and when they survive, they develop more severe cognitive dysfunctions. Reducing the rebleeds by ultra-early administration of tranexamic acid (TXA) could be a major factor in improving the functional outcome after SAH.
To evaluate whether SAH patients treated by state-of-the-art SAH management with additional ultra-early and short term TXA administration have a significantly higher percentage of favourable outcome after six months (score 0-3 on the Modified Rankin Scale) compared to the group treated by up-to-date SAH management without additional TXA.
To evaluate whether: 1) TXA reduces in-hospital rebleeds and case fatalities; 2) TXA causes more ischemic stroke 3) TXA causes more complications (such as thromboembolic events, hydrocephalus, extracranial thrombosis or hemorrhagic complications) during treatment, admission and follow-up; 4) there is a difference in causes of poor outcome between groups; 5) there is a difference in discharge locations between groups; 6) there is an association between the time between hemorrhage and TXA administration and outcome; 7) TXA increases (micro)infarctions after endovascular treatment; 8) TXA reduces health-care costs between discharge and six months after hemorrhage; 9) TXA improves quality of life at six months after hemorrhage; 10) there are differences in rebleed rates and outcome between genders or groups with different WFNS scores at admission.
Multicenter, prospective, randomized, open label treatment with blind endpoint assessment.
Adult patients (18 years and older) included within 24 hours after SAH. Group one: standard treatment with additional administration of 1 g TXA intravenously in ten minutes, immediately after the diagnosis SAH, succeeded by continuous infusion of 1 g per 8 hours until a maximum of 24 hours. Group two: standard treatment with no TXA administration. Both groups undergo a standardized and validated interview at discharge and six months after hemorrhage to assess the modified Rankin Scale score, and both groups receive a questionnaire to evaluate health-care costs and quality of life.
Primary: modified Rankin Scale score after six months, dichotomized into favourable and unfavourable outcome. Secondary: rebleed and case fatality rate, complications during the first six months after hemorrhage, (micro)infarctions at MR imaging after endovascular treatment, health-care costs from discharge until six months, quality of life at six months and differences in rebleed rates and outcome between genders or WFNS score at admission.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Subjects are randomly allocated to ultra-early TXA therapy or standard treatment. Complications are minor and the expected benefit is large compared with separate studies done with antifibrinolytic medications. In these studies, the safety of the use of these medications in this study population is confirmed. In this patient group there are adequate, disoriented and comatose patients on admission, so a part of the studied patients are incapacitated when undergoing the study. To extrapolate the conclusions of this study to clinical protocols it is necessary to include patients with a SAH in all different severity grades. Weighing carefully the benefits versus the burden and risks, it is assumed that patients will benefit from ultra-early TXA administration with minimal burden during therapy.
- Conditions
- Subarachnoid Hemorrhage
- Being tested
- Tranexamic Acid
- Keywords
- antifibrinolytic therapy, recurrent bleeding, tranexamic acid
- Medical subject headings
- Subarachnoid Hemorrhage, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
Also called Cyklokapron
Treatment until aneurysm treatment or maximum dosage of 4 gram
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic Acid | Active comparator | Eligible subjects are randomly assigned to immediate administration of TXA (1 g i.v.) after a diagnosis of SAH, as confirmed by CT-scan of the brain, continued by continuous infusion of 1 g per 8 hours to a maximum of 24 hours after start of medication. A maximum of 4 g TXA (1 g bolus + 3x 1 g continuous infusion) can be administered to one patient. Receives: Drug: Tranexamic Acid |
| Control | No intervention | Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin Scale (mRS)
Good (mRS 0-3) and Poor (mRS 4-6)
Measured: six months
Secondary outcomes (13)
Date and cause of death
Assessment of cause of death by a committee (intensive care/neurosurgeon)
Measured: Maximum six month
Cause of poor outcome
Assessment of which events during hospital admission led to a poor outcome defined as mRS 4 and 5 by a committee (intensive care/neurosurgeon)
Measured: six months
Rebleed and time interval after first hemorrhage
The time interval between the initial hemorrhage and occurence of a recurrent bleeding will be recorded.
Measured: six months
Thromboembolic events during endovascular treatment
Complications during endovascular treatment will be recorded (ie occurence of clotting in one of the vessels)
Measured: up to 48 hours
Ischemic stroke (Dealyed cerebral ischemia)
Measured: 14-20 days
Extracranial thrombosis
Measured: six months
Hydrocephalus and treatment modality
Occurence of a hydrocephalus will be recorded and which treatment modality is used to treat the hydrocephalus
Measured: six months
Hemorrhagic complications (intra- and extracranial)
Measured: six months
Time interval from last hemorrhage to first TXA administration
Measured: 24 hours
Discharge location
Measured: six months
Infarctions on MR imaging at six months after endovascular treatment
Measured: six months
Health-care costs between discharge and six months after hemorrhage
Questionnaires
Measured: three and six months
Quality of life at six months after hemorrhage
Questionnaire (EQ-5D)
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2016 (estimated)
- Study start16 Jul 2012
- Primary completion29 Jul 2019
- Study completion1 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Subarachnoid HemorrhageStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 955 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Stichting Nuts Ohra
- Responsible party
- Principal investigator, R. Post, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- William P Vandertop, PhD MD, Principal investigator, Department of Neurosurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02684812
- Sponsor's protocol ID
- 2012-000343-26
- Acronym
- ULTRA
- Status last verified
- Nov 2020
- First submitted
- 9 Feb 2016
- Last updated
- 12 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Germans MR, Post R, Coert BA, Rinkel GJ, Vandertop WP, Verbaan D. Ultra-early tranexamic acid after subarachnoid hemorrhage (ULTRA): study protocol for a randomized controlled trial. Trials. 2013 May 16;14:143. doi: 10.1186/1745-6215-14-143.
PubMed 23680226Koopmans RJ, Tjerkstra MA, Germans MR, Vergouwen MDI, Jellema K, Koot RW, Kruyt ND, Wolfs JFC, Kieft H, Nanda D, van der Pol B, Roks G, de Beer F, Reichman LJA, Brouwers PJAM, Kwa VIH, van der Ree TC, Bienfait HP, Boogaarts HD, Klijn CJM, van den Berg R, Coert BA, Horn J, Majoie CBLM, Rinkel GJE, Roos YBWEM, Vandertop WP, Post R, Verbaan D; ULTRA Investigators. Tranexamic acid after aneurysmal subarachnoid hemorrhage is associated with worse outcome in males: post hoc analysis of the ULTRA trial. J Neurol. 2026 Aug 19;273(9):528. doi: 10.1007/s00415-026-14037-z.
PubMed 42616160Denneman N, Kamra T, Post R, Tjerkstra MA, Germans MR, Vergouwen MDI, Jellema K, Koot RW, Kruyt ND, Wolfs JFC, Nanda D, Van Der Pol B, Roks G, Reichman LJA, Brouwers PJAM, Kwa VIH, Bienfait HP, Boogaarts HD, Klijn CJ, van den Berg R, Coert BA, Horn J, Majoie CBLM, Rinkel GJE, Roos YBWEM, Vandertop WP, Verbaan D; ULTRA trial study group. Quality of life after tranexamic acid in subarachnoid hemorrhage: post-hoc analysis of the ULTRA trial. Qual Life Res. 2026 May 3;35(6):148. doi: 10.1007/s11136-026-04263-3.
PubMed 42070193Denneman N, Post R, van Eekelen R, Tjerkstra MA, Kempeneers MA, Labib H, Germans MR, Vergouwen MDI, Jellema K, Koot RW, Kruyt ND, Wolfs JFC, Nanda D, Van Der Pol B, Roks G, De Beer F, Reichman LJA, Brouwers PJAM, Vincent HK 1st, Bienfait HP, Boogaarts HD, Klijn CJM, van den Berg R, Coert BA, Horn J, Majoie CBLM, Rinkel GJE, Roos YBWEM, Vandertop WP, Verbaan D; ULTRA trial study group. Cost-Effectiveness of Ultra-Early Tranexamic Acid as Add-On to Standard Care After Subarachnoid Hemorrhage (ULTRA Trial). Eur J Neurol. 2025 Aug;32(8):e70208. doi: 10.1111/ene.70208.
PubMed 40843772Tjerkstra MA, Post R, Germans MR, Vergouwen MDI, Jellema K, Koot RW, Kruyt ND, Wolfs JFC, De Beer FC, Kieft HH, Nanda D, Van Der Pol B, Roks G, De Beer F, Reichman LJA, Brouwers PJAM, Kwa VIH, Van Der Ree TC, Bienfait HP, Boogaarts HD, Klijn CJ, Visser V, van den Berg R, Coert BA, Horn J, Majoie CBLM, Rinkel GJE, Roos YBWEM, Vandertop WP, Verbaan D; ULTRA trial study group. Ultra-Early and Short-Term Tranexamic Acid Treatment in Patients With Good- and Poor-Grade Aneurysmal Subarachnoid Hemorrhage. Neurology. 2024 Jun 25;102(12):e209169. doi: 10.1212/WNL.0000000000209169. Epub 2024 May 24.
PubMed 38788175Vergouwen MD, Germans MR, Post R, Tjerkstra MA, Coert BA, Rinkel GJ, Peter Vandertop W, Verbaan D. Aneurysm treatment within 6 h versus 6-24 h after rupture in patients with subarachnoid hemorrhage. Eur Stroke J. 2023 Sep;8(3):802-807. doi: 10.1177/23969873231173273. Epub 2023 May 1.
PubMed 37641555Tjerkstra MA, Post R, Germans MR, Vergouwen MDI, Jellema K, Koot RW, Kruyt ND, Willems PWA, Wolfs JFC, de Beer FC, Kieft H, Nanda D, van der Pol B, Roks G, de Beer F, Halkes PHA, Reichman LJA, Brouwers PJAM, Van den Berg-Vos RM, Kwa VIH, van der Ree TC, Bronner I, Bienfait HP, Boogaarts H, Klijn CJM, van den Berg R, Coert BA, Horn J, Majoie CBLM, Rinkel GJE, Roos YBWM, Vandertop WP, Verbaan D; ULTRA investigators. Tranexamic Acid After Aneurysmal Subarachnoid Hemorrhage: Post Hoc Analysis of the ULTRA Trial. Neurology. 2022 Dec 5;99(23):e2605-e2614. doi: 10.1212/WNL.0000000000201160.
PubMed 36266046Post R, Germans MR, Tjerkstra MA, Vergouwen MDI, Jellema K, Koot RW, Kruyt ND, Willems PWA, Wolfs JFC, de Beer FC, Kieft H, Nanda D, van der Pol B, Roks G, de Beer F, Halkes PHA, Reichman LJA, Brouwers PJAM, van den Berg-Vos RM, Kwa VIH, van der Ree TC, Bronner I, van de Vlekkert J, Bienfait HP, Boogaarts HD, Klijn CJM, van den Berg R, Coert BA, Horn J, Majoie CBLM, Rinkel GJE, Roos YBWEM, Vandertop WP, Verbaan D; ULTRA Investigators. Ultra-early tranexamic acid after subarachnoid haemorrhage (ULTRA): a randomised controlled trial. Lancet. 2021 Jan 9;397(10269):112-118. doi: 10.1016/S0140-6736(20)32518-6. Epub 2020 Dec 23.
PubMed 33357465Post R, Germans MR, Coert BA, Rinkel GJE, Vandertop WP, Verbaan D. Update of the ULtra-early TRranexamic Acid after Subarachnoid Hemorrhage (ULTRA) trial: statistical analysis plan. Trials. 2020 Feb 18;21(1):199. doi: 10.1186/s13063-020-4118-5.
PubMed 32070395
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultra-early Tranexamic Acid After Subarachnoid Hemorrhage. A Prospective, Randomized, Multicenter Study.
- ClinicalTrials.gov ID
- NCT02684812
- Acronym / sponsor ID
- ULTRA / 2012-000343-26
- Conditions
- Subarachnoid Hemorrhage
- Keywords
- antifibrinolytic therapy, recurrent bleeding, tranexamic acid
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 955 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Stichting Nuts Ohra
- Study start
- 16 Jul 2012 (actual)
- Primary completion
- 29 Jul 2019 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 18 Feb 2016 (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.
This is a multicenter, prospective, randomized, open-label trial with blinded endpoint (PROBE) assessment. Adult patients with the diagnosis of non-traumatic SAH, as proven by computed tomography (CT) within 24 hours after the onset of headache, will be randomly assigned to the treatment group or the control group. Patients in the treatment group will receive standard treatment with the addition of a bolus of TXA (1 g intravenously) immediately after randomization, followed by continuous infusion of 1 g per 8 hours until the start of aneurysm treatment, or a maximum of 24 hours after the start of medication. Patients in the control group will receive standard treatment without TXA. The primary outcome measure is favorable functional outcome, defined as a score of 0 to 3 on the modified Rankin Scale (mRS), at 6 months after SAH. Primary outcome will be determined by a trial nurse blinded for treatment allocation.
Detailed description
Approximately 50% of all patients with a subarachnoid hemorrhage (SAH) die due to the hemorrhage or subsequent complications. There are several major causes for this course, such as in-hospital rebleed in 21.5% which most frequently occurs within the first 6 hours after the primary hemorrhage ("ultra-early rebleed"). A major part of the patients with a rebleed die during hospital admission and when they survive, they develop more severe cognitive dysfunctions. Reducing the rebleeds by ultra-early administration of tranexamic acid (TXA) could be a major factor in improving the functional outcome after SAH.
To evaluate whether SAH patients treated by state-of-the-art SAH management with additional ultra-early and short term TXA administration have a significantly higher percentage of favourable outcome after six months (score 0-3 on the Modified Rankin Scale) compared to the group treated by up-to-date SAH management without additional TXA.
To evaluate whether: 1) TXA reduces in-hospital rebleeds and case fatalities; 2) TXA causes more ischemic stroke 3) TXA causes more complications (such as thromboembolic events, hydrocephalus, extracranial thrombosis or hemorrhagic complications) during treatment, admission and follow-up; 4) there is a difference in causes of poor outcome between groups; 5) there is a difference in discharge locations between groups; 6) there is an association between the time between hemorrhage and TXA administration and outcome; 7) TXA increases (micro)infarctions after endovascular treatment; 8) TXA reduces health-care costs between discharge and six months after hemorrhage; 9) TXA improves quality of life at six months after hemorrhage; 10) there are differences in rebleed rates and outcome between genders or groups with different WFNS scores at admission.
Multicenter, prospective, randomized, open label treatment with blind endpoint assessment.
Adult patients (18 years and older) included within 24 hours after SAH. Group one: standard treatment with additional administration of 1 g TXA intravenously in ten minutes, immediately after the diagnosis SAH, succeeded by continuous infusion of 1 g per 8 hours until a maximum of 24 hours. Group two: standard treatment with no TXA administration. Both groups undergo a standardized and validated interview at discharge and six months after hemorrhage to assess the modified Rankin Scale score, and both groups receive a questionnaire to evaluate health-care costs and quality of life.
Primary: modified Rankin Scale score after six months, dichotomized into favourable and unfavourable outcome. Secondary: rebleed and case fatality rate, complications during the first six months after hemorrhage, (micro)infarctions at MR imaging after endovascular treatment, health-care costs from discharge until six months, quality of life at six months and differences in rebleed rates and outcome between genders or WFNS score at admission.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Subjects are randomly allocated to ultra-early TXA therapy or standard treatment. Complications are minor and the expected benefit is large compared with separate studies done with antifibrinolytic medications. In these studies, the safety of the use of these medications in this study population is confirmed. In this patient group there are adequate, disoriented and comatose patients on admission, so a part of the studied patients are incapacitated when undergoing the study. To extrapolate the conclusions of this study to clinical protocols it is necessary to include patients with a SAH in all different severity grades. Weighing carefully the benefits versus the burden and risks, it is assumed that patients will benefit from ultra-early TXA administration with minimal burden during therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tranexamic Acid | Active comparator | Drug: Tranexamic AcidEligible subjects are randomly assigned to immediate administration of TXA (1 g i.v.) after a diagnosis of SAH, as confirmed by CT-scan of the brain, continued by continuous infusion of 1 g per 8 hours to a maximum of 24 hours after start of medication. A maximum of 4 g TXA (1 g bolus + 3x 1 g continuous infusion) can be administered to one patient. |
| Control | No intervention | –Standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Admission to one of the study centers or their referring hospitals
- CT-confirmed SAH with most recent ictus less than 24 hours ago Definition: subarachnoid hemorrhage is a bleeding pattern on computed tomography with hyperdensity in the basal cisterns and/or Sylvian or interhemipheric fissures or a intraparenchymal hyperdensity consistent with a hematoma from an anterior, a pericallosal, a posterior or a middle cerebral artery aneurysm.
Key exclusion criteria (9 listed)
- No proficiency of the Dutch or English language
- No loss of consciousness after the hemorrhage with WFNS grade 1 or 2 on admission in combination with a perimesencephalic hemorrhage Definition: on CT examination presence of hyperdensities exclusively in the basal cisterns maximal extending to the proximal part of the Sylvian fissure or posterior part of the interhemispheric fissure, without evidence for intracerebral or intraventricular haemorrhage (except slight sedimentation)
- Bleeding pattern on CT compatible with a traumatic SAH
- Treatment for deep vein thrombosis or pulmonary embolism
- History of a blood coagulation disorder (a hypercoagulability disorder)
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 AcidAlso: CyklokapronTreatment until aneurysm treatment or maximum dosage of 4 gram | Drug | Tranexamic Acid |
Primary outcome
Modified Rankin Scale (mRS)
Time frame: six months
Good (mRS 0-3) and Poor (mRS 4-6)
13 secondary outcomes
Date and cause of death
Time frame: Maximum six month
Cause of poor outcome
Time frame: six months
Rebleed and time interval after first hemorrhage
Time frame: six months
Thromboembolic events during endovascular treatment
Time frame: up to 48 hours
Ischemic stroke (Dealyed cerebral ischemia)
Time frame: 14-20 days
Extracranial thrombosis
Time frame: six months
Hydrocephalus and treatment modality
Time frame: six months
Hemorrhagic complications (intra- and extracranial)
Time frame: six months
Time interval from last hemorrhage to first TXA administration
Time frame: 24 hours
Discharge location
Time frame: six months
Infarctions on MR imaging at six months after endovascular treatment
Time frame: six months
Health-care costs between discharge and six months after hemorrhage
Time frame: three and six months
Quality of life at six months after hemorrhage
Time frame: six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2020.
- Results publication: PubMed 23680226Germans MR, Post R, Coert BA, Rinkel GJ, Vandertop WP, Verbaan D. Ultra-early tranexamic acid after subarachnoid hemorrhage (ULTRA): study protocol for a randomized controlled trial. Trials. 2013 May 16;14:143. doi: 10.1186/1745-6215-14-143.
- Derived from this study: PubMed 42616160Koopmans RJ, Tjerkstra MA, Germans MR, Vergouwen MDI, Jellema K, Koot RW, Kruyt ND, Wolfs JFC, Kieft H, Nanda D, van der Pol B, Roks G, de Beer F, Reichman LJA, Brouwers PJAM, Kwa VIH, van der Ree TC, Bienfait HP, Boogaarts HD, Klijn CJM, van den Berg R, Coert BA, Horn J, Majoie CBLM, Rinkel GJE, Roos YBWEM, Vandertop WP, Post R, Verbaan D; ULTRA Investigators. Tranexamic acid after aneurysmal subarachnoid hemorrhage is associated with worse outcome in males: post hoc analysis of the ULTRA trial. J Neurol. 2026 Aug 19;273(9):528. doi: 10.1007/s00415-026-14037-z.
- Derived from this study: PubMed 42070193Denneman N, Kamra T, Post R, Tjerkstra MA, Germans MR, Vergouwen MDI, Jellema K, Koot RW, Kruyt ND, Wolfs JFC, Nanda D, Van Der Pol B, Roks G, Reichman LJA, Brouwers PJAM, Kwa VIH, Bienfait HP, Boogaarts HD, Klijn CJ, van den Berg R, Coert BA, Horn J, Majoie CBLM, Rinkel GJE, Roos YBWEM, Vandertop WP, Verbaan D; ULTRA trial study group. Quality of life after tranexamic acid in subarachnoid hemorrhage: post-hoc analysis of the ULTRA trial. Qual Life Res. 2026 May 3;35(6):148. doi: 10.1007/s11136-026-04263-3.
- Derived from this study: PubMed 40843772Denneman N, Post R, van Eekelen R, Tjerkstra MA, Kempeneers MA, Labib H, Germans MR, Vergouwen MDI, Jellema K, Koot RW, Kruyt ND, Wolfs JFC, Nanda D, Van Der Pol B, Roks G, De Beer F, Reichman LJA, Brouwers PJAM, Vincent HK 1st, Bienfait HP, Boogaarts HD, Klijn CJM, van den Berg R, Coert BA, Horn J, Majoie CBLM, Rinkel GJE, Roos YBWEM, Vandertop WP, Verbaan D; ULTRA trial study group. Cost-Effectiveness of Ultra-Early Tranexamic Acid as Add-On to Standard Care After Subarachnoid Hemorrhage (ULTRA Trial). Eur J Neurol. 2025 Aug;32(8):e70208. doi: 10.1111/ene.70208.
- Derived from this study: PubMed 38788175Tjerkstra MA, Post R, Germans MR, Vergouwen MDI, Jellema K, Koot RW, Kruyt ND, Wolfs JFC, De Beer FC, Kieft HH, Nanda D, Van Der Pol B, Roks G, De Beer F, Reichman LJA, Brouwers PJAM, Kwa VIH, Van Der Ree TC, Bienfait HP, Boogaarts HD, Klijn CJ, Visser V, van den Berg R, Coert BA, Horn J, Majoie CBLM, Rinkel GJE, Roos YBWEM, Vandertop WP, Verbaan D; ULTRA trial study group. Ultra-Early and Short-Term Tranexamic Acid Treatment in Patients With Good- and Poor-Grade Aneurysmal Subarachnoid Hemorrhage. Neurology. 2024 Jun 25;102(12):e209169. doi: 10.1212/WNL.0000000000209169. Epub 2024 May 24.
- Derived from this study: PubMed 37641555Vergouwen MD, Germans MR, Post R, Tjerkstra MA, Coert BA, Rinkel GJ, Peter Vandertop W, Verbaan D. Aneurysm treatment within 6 h versus 6-24 h after rupture in patients with subarachnoid hemorrhage. Eur Stroke J. 2023 Sep;8(3):802-807. doi: 10.1177/23969873231173273. Epub 2023 May 1.
- Derived from this study: PubMed 36266046Tjerkstra MA, Post R, Germans MR, Vergouwen MDI, Jellema K, Koot RW, Kruyt ND, Willems PWA, Wolfs JFC, de Beer FC, Kieft H, Nanda D, van der Pol B, Roks G, de Beer F, Halkes PHA, Reichman LJA, Brouwers PJAM, Van den Berg-Vos RM, Kwa VIH, van der Ree TC, Bronner I, Bienfait HP, Boogaarts H, Klijn CJM, van den Berg R, Coert BA, Horn J, Majoie CBLM, Rinkel GJE, Roos YBWM, Vandertop WP, Verbaan D; ULTRA investigators. Tranexamic Acid After Aneurysmal Subarachnoid Hemorrhage: Post Hoc Analysis of the ULTRA Trial. Neurology. 2022 Dec 5;99(23):e2605-e2614. doi: 10.1212/WNL.0000000000201160.
- Derived from this study: PubMed 33357465Post R, Germans MR, Tjerkstra MA, Vergouwen MDI, Jellema K, Koot RW, Kruyt ND, Willems PWA, Wolfs JFC, de Beer FC, Kieft H, Nanda D, van der Pol B, Roks G, de Beer F, Halkes PHA, Reichman LJA, Brouwers PJAM, van den Berg-Vos RM, Kwa VIH, van der Ree TC, Bronner I, van de Vlekkert J, Bienfait HP, Boogaarts HD, Klijn CJM, van den Berg R, Coert BA, Horn J, Majoie CBLM, Rinkel GJE, Roos YBWEM, Vandertop WP, Verbaan D; ULTRA Investigators. Ultra-early tranexamic acid after subarachnoid haemorrhage (ULTRA): a randomised controlled trial. Lancet. 2021 Jan 9;397(10269):112-118. doi: 10.1016/S0140-6736(20)32518-6. Epub 2020 Dec 23.
- Derived from this study: PubMed 32070395Post R, Germans MR, Coert BA, Rinkel GJE, Vandertop WP, Verbaan D. Update of the ULtra-early TRranexamic Acid after Subarachnoid Hemorrhage (ULTRA) trial: statistical analysis plan. Trials. 2020 Feb 18;21(1):199. doi: 10.1186/s13063-020-4118-5.
- Individual participant dataSharing planned: Undecided
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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.
William P Vandertop, PhD MD principal investigator
Department of Neurosurgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Tranexamic Acid in people with Subarachnoid Hemorrhage, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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 9 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: finished, as of the sponsor's last update on 12 Nov 2020. 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 Netherlands. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Rankin Scale (mRS) (time frame: six months). 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 NCT02684812, which also lists 9 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 12 Nov 2020.