Subdural HematomaPhase 4TXA in CSDHNCT02618382
A Study on the Safety of Tranexamic Acid for the Chronic Subdural Hematoma Population
A Phase 4 study testing Tranexamic Acid in people with Subdural Hematoma, run by St. Joseph's Hospital and Medical Center, Phoenix at 1 site in United States.
Trial summary
This is a single center single arm study of 50 patients to 1) determine the safety of tranexamic acid in the chronic subdural hematoma population following surgical drainage of chronic subdural hematomas and 2) determine if the use of oral tranexamic acid reduces the rate of ipsilateral recurrence following drainage… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Subdural Hematoma
- What is being tested?
- Tranexamic Acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2015to 12 Jun 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all patients undergoing intervention for chronic subdural hematoma (cSDH) including drainage
- cSDH will be defined as hematoma on CT imaging that is predominantly iso- to hypodense to brain
- 18-85 years of age
Who cannot join
- cSDH not requiring surgical drainage
- patients undergoing bedside twist drill craniostomy
- medically unstable for surgery
- patients requiring long-term anticoagulation (unable to stay off for less than 30 days)
- patients not expected to survive to the completion of followup
- patients comatose prior to the initiation of treatment
Show all 16Show fewer
- history of thromboembolic problem including stroke, myocardial infarction, deep vein thrombosis and/or pulmonary embolism
- pregnant
- minor
- allergy/sensitivity to tranexamic acid
- irreversible coagulopathy
- known clotting disorder
- bilateral hematomas with both requiring drainage
- incarcerated
- any patient not judged suitable for the study by the investigators
- women who are taking combination hormonal contraception
Trial locations and contacts
1 site in 1 country.
About this study
This is a single center single arm study of 50 patients to 1) determine the safety of tranexamic acid in the chronic subdural hematoma population following surgical drainage of chronic subdural hematomas and 2) determine if the use of oral tranexamic acid reduces the rate of ipsilateral recurrence following drainage of chronic subdural hematomas. This will be compared to historical controls. This study intends to be a prerequisite to a large nationally funded randomized control trial.
Read the detailed description
Chronic subdural hematomas are a common problem faced by neurosurgery with an annual incidence of 13.5/100,00 persons per year and up to 58/100,000 in the over 65 years old population. Their treatment is often complicated by recurrence with rates reported as high as 33%. Currently there is no good strategy to help avoid this problem, which adds significantly to patient morbidity. The pathogenesis of this problem is believed to be related to the propensity of the associated neo-membranes to bleed. It has been shown with labeled red blood cells that bleeding continues to occur into the hematoma cavity. It has also been shown that there are high levels of tissue plasminogen activator in the outer membrane of chronic subdural hematomas. It has been found that ratio of tissue plasminogen activator to plasminogen activator inhibitor contributed to the pathogenesis. It has also been shown that chronic subdural hematomas have high levels of fibrin degradation products which in addition to marking the breakdown of fibrin are themselves antihemostatic by enhancing tissue plasminogen activator activity, having an antithrombin affect and inhibiting platelet aggregation and fibrin polymerization. Essentially, a scenario of ongoing hemorrhage and repeated clot formation and hyperfibrinolysis leads to the expansion and recurrence of chronic subdural hematomas.
Given the importance of plasmin and hyperfibrinolysis in the pathophysiology of chronic subdural hematomas, interrupting its action and the vicious cycle it propagates seems an ideal therapeutic target. Tranexamic acid is a synthetic lysine amino acid derivative. It binds to the fibrin binding sites on plasmin or plasminogen and prevents its interaction and degradation of fibrin. This effect on the neo-membranes of chronic subdural hematomas should prevent rebleeding and the reaccumulation of the subdural hematoma.
Tranexamic acid has been shown to be safe and effective in reducing blood loss and transfusions in a number of types of surgery, reduced mortality and need for urgent surgery in patients with GI bleeding, and reduced bleeding associated with menorrhagia and pregnancy. Adverse effects are generally mild. Thought there is a theoretical increased risk of thromboembolic complications, multiple randomized controlled trials have not shown an increased risk. Furthermore, in a study of over 3000 gynecologic patients using tranexamic acid, there were no thromboembolic complications. This is likely because tranexamic acid has been shown to not have an effect on plasminogen in the vein wall.
- Conditions
- Subdural Hematoma
- Being tested
- Tranexamic Acid
- Medical subject headings
- Hematoma, Subdural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
Also called Lysteda, Cyklokapron
1300mg tranexamic acid by mouth once before surgery and then three times a day for up to three days or until they are discharged from the hospital, whichever comes first
| Study group | Role | What they receive |
|---|---|---|
| All subjects | Experimental | Patients will undergo standard treatment of their chronic subdural hematoma with the addition of preoperative and postoperative oral tranexamic acid treatment. Patients will receive a dose of 1300mg orally three to four hours prior to surgery. They will then take 1300mg orally three times daily for three days or until discharge, whichever occurs first. Receives: Drug: Tranexamic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Medication Related (Thromboembolic) Complications
occurrence of stroke, myocardial infarction, deep vein thrombosis, and/or pulmonary embolism within 30 days
Measured: 30 days
Secondary outcomes (3)
Hematoma Thickness on CT Scan
Hematoma width (measured in cm) on post operative CT scans compared to baseline (preoperative). Preoperative axial non-contrast CT images were reviewed by a study investigator for maximal hematoma thickness, the presence of septations, and midline shift. Septations were determined to be present if there were thin, hyperdense, dividing membranes within the limits of the subdural collection. Postoperative axial non-contrast CT was planned within 24 hours post surgery and on postoperative days 3 and 30 (which could be scheduled within 7 days of the 30-day mark) to determine maximal hematoma thickness and midline shift using the preoperative methodology.
Measured: postoperative days 1, 3, and 30+/-7 days
Functional Status Determined by Modified Rankin Score (mRS) From Baseline to 30 Days Postop
The Modified Rankin Score (mRS) is a 6 point disability scale with scores ranging from 0 to 5. A separate category of 6 is usually added for patients who expire.
Lower score of 0, 1,2 are the best outcome up to 5 with worst outcome. 0 The patient has no residual symptoms.
- The patient has no significant disability; able to resume all pre-stroke activities.
- The patient has slight disability; unable to resume all pre-stroke activities but able to look after self without daily help.
- The patient has moderate disability; requiring some external help but able to walk without the assistance of another individual.
- The patient has moderately severe disability; unable to walk or attend to bodily functions without assistance.
- The patient has severe disability; bedridden, incontinent, requires continuous care.
- The patient has expired (during the hospital stay or after discharge from the hospital).
A chi -squared test was used for categorical value
Measured: Measured between 2 timepoints: Baseline(Day 0) and postoperative (day 30)
Change in National Institute of Health Stroke Scale (NIHSS)
National Institute of Health Stroke Scale (NIHSS) (0-42); 0 is better, 42 is worse.
The NIHSS measures several aspects of brain function, including consciousness, vision, sensation, movement, speech, and language. A certain number of points are given for each of these physical and cognitive functions during a focused neurological examination. A maximum score of 42 represents the most severe and devastating stroke.
The levels of stroke severity as measured by the NIHSS scoring system are:
0 = no stroke 1-4 = minor stroke 5-15 = moderate stroke 15-20 = moderate/severe stroke 21-42 = severe stroke
Measured: Immediately preoperative (Day 0) and discharge (up to 30 days postoperative)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2015 (estimated)
- Study start1 Nov 2015
- Primary completion1 Aug 2017
- Study completion12 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Subdural HematomaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Hospital and Medical Center, Phoenix
- Sponsor type
- University, hospital or other
- Collaborators
- Barrow Neurological Foundation
- Responsible party
- Principal investigator, Lisa Arnold, St. Joseph's Hospital and Medical Center, Phoenix
- Investigators
- Andrew S Little, MD, Principal investigator, Barrow Brain and Spine, Phoenix, AZ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02618382
- Sponsor's protocol ID
- PHX15BN048
- Acronym
- TXA in CSDH
- Status last verified
- Nov 2021
- First submitted
- 23 Nov 2015
- Last updated
- 11 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Safety of Tranexamic Acid for the Chronic Subdural Hematoma Population
- ClinicalTrials.gov ID
- NCT02618382
- Acronym / sponsor ID
- TXA in CSDH / PHX15BN048
- Conditions
- Subdural Hematoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- St. Joseph's Hospital and Medical Center, PhoenixUniversity, hospital or other
- Collaborators
- Barrow Neurological Foundation
- Study start
- 1 Nov 2015 (actual)
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 12 Jun 2018 (actual)
- First posted
- 1 Dec 2015 (estimated)
- Results
- Posted 9 Nov 2021
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 single center single arm study of 50 patients to 1) determine the safety of tranexamic acid in the chronic subdural hematoma population following surgical drainage of chronic subdural hematomas and 2) determine if the use of oral tranexamic acid reduces the rate of ipsilateral recurrence following drainage of chronic subdural hematomas. This will be compared to historical controls. This study intends to be a prerequisite to a large nationally funded randomized control trial.
Detailed description
Chronic subdural hematomas are a common problem faced by neurosurgery with an annual incidence of 13.5/100,00 persons per year and up to 58/100,000 in the over 65 years old population. Their treatment is often complicated by recurrence with rates reported as high as 33%. Currently there is no good strategy to help avoid this problem, which adds significantly to patient morbidity. The pathogenesis of this problem is believed to be related to the propensity of the associated neo-membranes to bleed. It has been shown with labeled red blood cells that bleeding continues to occur into the hematoma cavity. It has also been shown that there are high levels of tissue plasminogen activator in the outer membrane of chronic subdural hematomas. It has been found that ratio of tissue plasminogen activator to plasminogen activator inhibitor contributed to the pathogenesis. It has also been shown that chronic subdural hematomas have high levels of fibrin degradation products which in addition to marking the breakdown of fibrin are themselves antihemostatic by enhancing tissue plasminogen activator activity, having an antithrombin affect and inhibiting platelet aggregation and fibrin polymerization. Essentially, a scenario of ongoing hemorrhage and repeated clot formation and hyperfibrinolysis leads to the expansion and recurrence of chronic subdural hematomas.
Given the importance of plasmin and hyperfibrinolysis in the pathophysiology of chronic subdural hematomas, interrupting its action and the vicious cycle it propagates seems an ideal therapeutic target. Tranexamic acid is a synthetic lysine amino acid derivative. It binds to the fibrin binding sites on plasmin or plasminogen and prevents its interaction and degradation of fibrin. This effect on the neo-membranes of chronic subdural hematomas should prevent rebleeding and the reaccumulation of the subdural hematoma.
Tranexamic acid has been shown to be safe and effective in reducing blood loss and transfusions in a number of types of surgery, reduced mortality and need for urgent surgery in patients with GI bleeding, and reduced bleeding associated with menorrhagia and pregnancy. Adverse effects are generally mild. Thought there is a theoretical increased risk of thromboembolic complications, multiple randomized controlled trials have not shown an increased risk. Furthermore, in a study of over 3000 gynecologic patients using tranexamic acid, there were no thromboembolic complications. This is likely because tranexamic acid has been shown to not have an effect on plasminogen in the vein wall.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All subjects | Experimental | Drug: Tranexamic AcidPatients will undergo standard treatment of their chronic subdural hematoma with the addition of preoperative and postoperative oral tranexamic acid treatment. Patients will receive a dose of 1300mg orally three to four hours prior to surgery. They will then take 1300mg orally three times daily for three days or until discharge, whichever occurs first. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- all patients undergoing intervention for chronic subdural hematoma (cSDH) including drainage
- cSDH will be defined as hematoma on CT imaging that is predominantly iso- to hypodense to brain
- 18-85 years of age
Key exclusion criteria (16 listed)
- cSDH not requiring surgical drainage
- patients undergoing bedside twist drill craniostomy
- medically unstable for surgery
- patients requiring long-term anticoagulation (unable to stay off for less than 30 days)
- patients not expected to survive to the completion of followup
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: Lysteda, Cyklokapron1300mg tranexamic acid by mouth once before surgery and then three times a day for up to three days or until they are discharged from the hospital, whichever comes first | Drug | All subjects |
Primary outcome
Number of Participants With Medication Related (Thromboembolic) Complications
Time frame: 30 days
occurrence of stroke, myocardial infarction, deep vein thrombosis, and/or pulmonary embolism within 30 days
3 secondary outcomes
Hematoma Thickness on CT Scan
Time frame: postoperative days 1, 3, and 30+/-7 days
Functional Status Determined by Modified Rankin Score (mRS) From Baseline to 30 Days Postop
Time frame: Measured between 2 timepoints: Baseline(Day 0) and postoperative (day 30)
Change in National Institute of Health Stroke Scale (NIHSS)
Time frame: Immediately preoperative (Day 0) and discharge (up to 30 days postoperative)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Andrew S Little, MD principal investigator
Barrow Brain and Spine, Phoenix, AZ
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 in people with Subdural Hematoma, run by St. Joseph's Hospital and Medical Center, Phoenix at 1 site in United States.
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 3 inclusion and 16 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 11 Nov 2021. 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 United States. 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?
Yes. Results are posted in the registry (first posted 9 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Medication Related (Thromboembolic) Complications (time frame: 30 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 11 Nov 2021.