Chronic Subdural HematomaPhase 2/3RATATANCT07245264
Adjuvant Tranexamic Acid (TXA) Versus Surgery Alone for Adult Patients With Chronic Subdural Hematoma (CSDH)
A Phase 2/3 study testing Tranexamic Acid (Cyklokapron) in people with Chronic Subdural Hematoma, run by St. Olavs Hospital at 1 site in India.
Trial summary
This study is an open label randomized controlled trial. Patients with a symptomatic Chronic Subdural Hematoma (CSDH) confirmed on radiological imaging, planned for surgery, age over 18, free from other intracranial pathologies and no previous intracranial surgery, will be recruited at time of admission. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Subdural Hematoma
- What is being tested?
- Tranexamic Acid (Cyklokapron)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 274 participants
- Where
- 1 siteIndia
- Study dates
- 10 Dec 2025to 1 Jun 2029
- Phase
- Phase 2/3
- 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
Who may be able to join
- Symptomatic chronic subdural hematoma confirmed on computer tomography (CT) or magnetic resonance imaging (MRI) measuring greater than 10 mm thickness.
- Adult patient ≥18 years
- Scheduled for single or double burr hole for evacuation.
- No contraindication for TXA
Who cannot join
- Mechanical heart valve
- Newly diagnosed (last 12 months) pulmonary embolism, myocardial infarction, and strong indication for antithrombotic treatment
- Intracranial surgery within last 6 months
- Pregnancy and woman<40 years
- Participation in any other clinical trial
- Life expectancy of less than one year.
Show all 11Show fewer
- A score on the modified Rankin scale, designed to assess functional independence, of 4 or 5 (scores range from 0 [no symptoms] to 6 [death]) before the hematoma occurred.
- Unfit for participations for any other reason as evaluated by the including physician.
- History of severe impairment of renal function (eGFR <30ml/min or serum creatinine >150μmol/L)
- Known hypersensitivity or allergy to TXA
- Inability to obtain informed consent from the patient or legal representative
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
Post Graduate Institute of Medical Education & Research
Chandigarh, 160012
Pravin Salunke, Professor, +91 99155 04 994, drpravin_salunke@yahoo.co.uk
Pravin Salunke, Professor
About this study
Official title: Randomized Trial Comparing Adjuvant Tranexamic Acid Versus Surgery Alone For Chronic Subdural Hematoma
This study is an open label randomized controlled trial. Patients with a symptomatic Chronic Subdural Hematoma (CSDH) confirmed on radiological imaging, planned for surgery, age over 18, free from other intracranial pathologies and no previous intracranial surgery, will be recruited at time of admission. Patients eligible for inclusion will be randomized to receive treatment with Tranexamic acid (TXA) as an adjunct to surgery or surgery alone. Surgical evacuation will be performed using a single or double burr hole and 24 hours postoperative drainage. The primary endpoint will be recurrent hematoma requiring repeat surgery within 90 days. Secondary outcomes will be modified Rankin Scale at 90 days, EQ-5D-5L, complications and adverse events, and 90-day mortality.
Read the detailed description
This study is a prospective single-center open-label randomized controlled trial (RCT) investigating whether the administration of tranexamic acid (TXA) as an adjuvant to surgery reduces the recurrence rate of chronic subdural hematoma (CSDH) compared to surgery alone.
CSDH is a frequent neurosurgical condition, especially among elderly patients, and carries a substantial risk of recurrence after surgical evacuation. Despite standardized procedures such as burr hole drainage and postoperative irrigation with 24-hour drainage, reoperation rates remain high (5-20%). There is currently a need for adjunctive therapies to reduce recurrence and improve clinical outcomes.
Tranexamic acid is a well-established antifibrinolytic agent that inhibits plasminogen activation and stabilizes blood clots. While observational studies and limited randomized trials have suggested a potential benefit of TXA in CSDH patients, conclusive evidence remains lacking.
This trial (RATATA) randomly assigns eligible adult patients with symptomatic CSDH confirmed via CT or MRI to receive either standard surgical treatment or surgery plus adjuvant TXA. Participants in the intervention arm receive a total of 2g IV TXA (1g <12h pre-op and 1g 12h post-op) and continue with oral TXA 500 mg twice daily for four weeks.
The primary endpoint is recurrence of the ipsilateral CSDH requiring repeat surgery within 90 days of the index operation. Recurrence is defined by both clinical deterioration and radiologically confirmed hematoma. Secondary endpoints include functional outcomes measured by the Modified Rankin Scale (mRS), health-related quality of life assessed using EQ-5D-5L, complication and adverse event rates, and 90-days mortality.
Imaging assessments will be conducted at baseline and during follow-up (post-operatively, week 4 and at surgeons´ discretion 12 weeks if indicated). The study also includes robust safety monitoring for thromboembolic and other TXA-related adverse events.
Randomization is stratified by age (≥60 vs. <60) and gender using a computer-generated block randomization scheme. Allocation concealment is ensured via sealed opaque envelopes, and outcomes assessors for imaging and functional scores are blinded to treatment assignment.
Sample size was calculated to detect a 12% absolute reduction in recurrence (from 18% to 6%), requiring 274 patients (137 per group) with 80% power and a two-sided alpha of 0.05, accounting for a 20% loss to follow-up.
The study follows Good Clinical Practice guidelines and the Declaration of Helsinki.
- Conditions
- Chronic Subdural Hematoma
- Being tested
- Tranexamic Acid (Cyklokapron)
- Keywords
- Chronic subdural hematoma, Tranexamic acid, Neurosurgery
- Medical subject headings
- Hematoma, Subdural, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic Acid (Cyklokapron)Drug
Patients randomized to the treatment group will receive 1g of TXA pre and postoperative intravenously administrated followed by a 28 days treatment course of 500mg x2 of TXA orally
| Study group | Role | What they receive |
|---|---|---|
| Standard surgical treatment with adjunctive treatment with tranexamic acid | Active comparator | Surgical evacuation with tranexamic acid. Preoperative administration of 1g IV with additional 1g administrated postoperatively. Followed by 500mg two times a day for a total of 28 days. Receives: Drug: Tranexamic Acid (Cyklokapron) |
| Standard surgical treatment | No intervention | Surgically evacuation of chronic subdural hematoma without adjuntive medical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of symptomatic chronic subdural hematoma requiring repeat surgery within 90 days
Number of patients with a radiological and clinical significant recurrent hematoma withing 90 days
Measured: 90 days
Secondary outcomes (5)
Functional outcome
Functional outcome measured with the modified Rankin Scale (mRS) score, range 0 (no symptoms) to 6 (death)
Measured: 90 days
Health-related Quality Of Life
Change from baseline in generic health-related quality of life measured with the five dimensional EuroQol questionnaire (EQ-5D-L)
Measured: 90 days
Headache
Change in headache intensity measured with numerical rating scale (1-10)
Measured: 90 days
Complications and adverse events
Complications and adverse events
Measured: 90 days
Mortality
Mortality
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start10 Dec 2025
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Subdural HematomaStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe 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
- None (open label)
- Enrolment
- 274 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Responsible party
- Sponsor
- Investigators
- Chandrashekhar Gendle, MD PhD, Study chair, Postgraduate Institute of Medical Education & Research (PGIMER)Mattis A Madsbu, MD PhD, Principal investigator, St. Olavs University Hospital, Department of NeurosurgerySasha Gulati, Professor, Study chair, St. Olavs University Hospital, Department of Neurosurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07245264
- Sponsor's protocol ID
- CHG-090891
- Acronym
- RATATA
- Status last verified
- Jul 2026
- First submitted
- 17 Nov 2025
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Comparing Adjuvant Tranexamic Acid Versus Surgery Alone For Chronic Subdural Hematoma
- ClinicalTrials.gov ID
- NCT07245264
- Acronym / sponsor ID
- RATATA / CHG-090891
- Conditions
- Chronic Subdural Hematoma
- Keywords
- Chronic subdural hematoma, Tranexamic acid, Neurosurgery
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 274 participants (estimated)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Study start
- 10 Dec 2025 (actual)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 24 Nov 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.
This study is an open label randomized controlled trial. Patients with a symptomatic Chronic Subdural Hematoma (CSDH) confirmed on radiological imaging, planned for surgery, age over 18, free from other intracranial pathologies and no previous intracranial surgery, will be recruited at time of admission. Patients eligible for inclusion will be randomized to receive treatment with Tranexamic acid (TXA) as an adjunct to surgery or surgery alone. Surgical evacuation will be performed using a single or double burr hole and 24 hours postoperative drainage. The primary endpoint will be recurrent hematoma requiring repeat surgery within 90 days. Secondary outcomes will be modified Rankin Scale at 90 days, EQ-5D-5L, complications and adverse events, and 90-day mortality.
Detailed description
This study is a prospective single-center open-label randomized controlled trial (RCT) investigating whether the administration of tranexamic acid (TXA) as an adjuvant to surgery reduces the recurrence rate of chronic subdural hematoma (CSDH) compared to surgery alone.
CSDH is a frequent neurosurgical condition, especially among elderly patients, and carries a substantial risk of recurrence after surgical evacuation. Despite standardized procedures such as burr hole drainage and postoperative irrigation with 24-hour drainage, reoperation rates remain high (5-20%). There is currently a need for adjunctive therapies to reduce recurrence and improve clinical outcomes.
Tranexamic acid is a well-established antifibrinolytic agent that inhibits plasminogen activation and stabilizes blood clots. While observational studies and limited randomized trials have suggested a potential benefit of TXA in CSDH patients, conclusive evidence remains lacking.
This trial (RATATA) randomly assigns eligible adult patients with symptomatic CSDH confirmed via CT or MRI to receive either standard surgical treatment or surgery plus adjuvant TXA. Participants in the intervention arm receive a total of 2g IV TXA (1g <12h pre-op and 1g 12h post-op) and continue with oral TXA 500 mg twice daily for four weeks.
The primary endpoint is recurrence of the ipsilateral CSDH requiring repeat surgery within 90 days of the index operation. Recurrence is defined by both clinical deterioration and radiologically confirmed hematoma. Secondary endpoints include functional outcomes measured by the Modified Rankin Scale (mRS), health-related quality of life assessed using EQ-5D-5L, complication and adverse event rates, and 90-days mortality.
Imaging assessments will be conducted at baseline and during follow-up (post-operatively, week 4 and at surgeons´ discretion 12 weeks if indicated). The study also includes robust safety monitoring for thromboembolic and other TXA-related adverse events.
Randomization is stratified by age (≥60 vs. <60) and gender using a computer-generated block randomization scheme. Allocation concealment is ensured via sealed opaque envelopes, and outcomes assessors for imaging and functional scores are blinded to treatment assignment.
Sample size was calculated to detect a 12% absolute reduction in recurrence (from 18% to 6%), requiring 274 patients (137 per group) with 80% power and a two-sided alpha of 0.05, accounting for a 20% loss to follow-up.
The study follows Good Clinical Practice guidelines and the Declaration of Helsinki.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard surgical treatment with adjunctive treatment with tranexamic acid | Active comparator | Drug: Tranexamic Acid (Cyklokapron)Surgical evacuation with tranexamic acid. Preoperative administration of 1g IV with additional 1g administrated postoperatively. Followed by 500mg two times a day for a total of 28 days. |
| Standard surgical treatment | No intervention | –Surgically evacuation of chronic subdural hematoma without adjuntive medical therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Symptomatic chronic subdural hematoma confirmed on computer tomography (CT) or magnetic resonance imaging (MRI) measuring greater than 10 mm thickness.
- Adult patient ≥18 years
- Scheduled for single or double burr hole for evacuation.
- No contraindication for TXA
Key exclusion criteria (11 listed)
- Mechanical heart valve
- Newly diagnosed (last 12 months) pulmonary embolism, myocardial infarction, and strong indication for antithrombotic treatment
- Intracranial surgery within last 6 months
- Pregnancy and woman<40 years
- Participation in any other 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic Acid (Cyklokapron)Patients randomized to the treatment group will receive 1g of TXA pre and postoperative intravenously administrated followed by a 28 days treatment course of 500mg x2 of TXA orally | Drug | Standard surgical treatment with adjunctive treatment with tranexamic acid |
Primary outcome
Recurrence of symptomatic chronic subdural hematoma requiring repeat surgery within 90 days
Time frame: 90 days
Number of patients with a radiological and clinical significant recurrent hematoma withing 90 days
5 secondary outcomes
Functional outcome
Time frame: 90 days
Health-related Quality Of Life
Time frame: 90 days
Headache
Time frame: 90 days
Complications and adverse events
Time frame: 90 days
Mortality
Time frame: 90 days
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 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Chandrashekhar Gendle, MD PhD study chair
Postgraduate Institute of Medical Education & Research (PGIMER)
Mattis A Madsbu, MD PhD principal investigator
St. Olavs University Hospital, Department of Neurosurgery
Sasha Gulati, Professor study chair
St. Olavs University Hospital, 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 (Cyklokapron) in people with Chronic Subdural Hematoma, run by St. Olavs Hospital at 1 site in India.
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 11 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 Jul 2026. 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 India. 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?
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 Chandrashekhar Gendle, MD PhD (+91 98781 52589, chandrashekhargonde@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of symptomatic chronic subdural hematoma requiring repeat surgery within 90 days (time frame: 90 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 17 Jul 2026.