Chronic Subdural HematomaNCT03831997
Effect of Different Intravenous Fluids on Post-operative Chronic Subdural Hematoma Size and Recurrence
An observational study of Chronic Subdural Hematoma, run by Carilion Clinic at 1 site in United States.
Trial summary
This study aims to reduce the recurrence rate of chronic subdural hematomas (CSDH) by manipulating the post-operative intravenous fluid use. The hypothesis relies on the relationship between osmolality and volume changes related to osmolality. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Subdural Hematoma
- What is being tested?
- Dextrose 5% W/ Sodium Chloride 0.225%
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2019to 1 Jun 2030
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We will be recruiting patients (male, female; 18-60 years old) from our center, Carilion Roanoke Memorial Hospital, that have been diagnosed with CSDH necessitating burr-hole evacuation who fit our inclusion and exclusion criteria.
Who may be able to join
- Diagnosis of chronic subdural hematoma (based on imaging)
- Need for surgical intervention (assessed by attending neurosurgeon based on full neurological assessment)
- The procedure of choice is burr hole drainage
- Cessation of anti-coagulant therapy with accompanying normal lab values in appropriate time frames respective to the drug
- Tolerance of supine position
Who cannot join
- <60 years old
- Presence of acute hemorrhage, stroke, or parenchymal damage
- Neurological deficits not accountable to mass effect
- Hyponatremia or inherent electrolyte imbalances
- Pregnancy or non-consentable patients
- Previous neurological surgery up to 1 year before being considered for the study
Show all 9Show fewer
- Rapid re-expansion of brain observed intraoperatively by attending neurosurgeon
- Congestive heart failure or other medical conditions precluding normal postoperative administration of IV fluids
- Blood glucose levels > 135 mg/dL
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, 24016
Eric Marvin, DO, 5405889711, eamarvin@carilionclinic.org
Ayesha Kar, 9082080082, akar@carilionclinic.org
About this study
Official title: The Effect of Dextrose 5% in 0.225% Sodium Chloride (D5 1/4NS) on Postoperative Chronic Subdural Hematoma Size and Recurrence Rate
This study aims to reduce the recurrence rate of chronic subdural hematomas (CSDH) by manipulating the post-operative intravenous fluid use. The hypothesis relies on the relationship between osmolality and volume changes related to osmolality. We will be administering dextrose 5% in 1/4 normal saline (D5 1/4NS) post-operatively to induce brain expansion which can take up the residual CSDH space, to help reduce recurrence rate.
Read the detailed description
Chronic subdural hematoma (CSDH) is a neurological disease characterized by a collection of fluid, blood, and blood degradation matter between the arachnoid and dura mater in a well-developed membrane cavity. The presentation of this disease begins with minor head trauma and takes 4-7 weeks to become symptomatic.
One of the significant problems exists with CSDH is the rate of recurrence, which currently stands at a 7-30% rate worldwide. The recurrence of a CSDH is typically defined as the presence of residual or recurrent CSDH after the first resolution, leading to additional surgical intervention either within 3 months (early recurrence) or after 3 months (late recurrence). Additional surgical intervention (recurrence rate) is the outcome variable that our study will be looking at. Factors leading to persistent recurrence include age, use of anticoagulant therapy, volume of hematoma cavity, degree of midline shift on CT, presence of residual air post-operatively, and volume of residual hematoma fluid. The variability in surgeons' operative and post-operative care, which tries to address the multiple factors that lead to recurrence, illustrates the difficulty in trying to reduce postoperative recurrence. In fact, there is no postoperative standard of care. These variations in operative and postoperative care have yet to significantly decrease the recurrent rate of CSDH.
Given the health status and fragility of the patient population that is most commonly affected by CSDHs, and the inherent morbidity related to operating on this population, we hypothesize that D5 1/4NS can help mitigate the issue of residual/recurrence CSDH leading to subsequent surgeries. The fluid dynamics of D5 1/4NS have been studied and we can assume that it will facilitate brain re-expansion.
- Conditions
- Chronic Subdural Hematoma
- Being tested
- Dextrose 5% W/ Sodium Chloride 0.225%
- 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.
Dextrose 5% W/ Sodium Chloride 0.225%Drug
Also called D5 1/4NS
D5 1/4NS is comprised of 5% dextrose in a 0.225% sodium chloride (NaCl) solution. D5 1/4NS is initially slightly hypertonic to plasma, with an osmolarity of 321 mOSm/L. As the glucose component is rapidly metabolized, 0.225% NaCl solution remains and is hypotonic to plasma at an osmolarity of 77 mOsm/L. Because of the hypotonicity of the 1/4NS, it shifts into the intracellular compartments, followed by free water, and allows for volume expansion.
| Study group | Role | What they receive |
|---|---|---|
| Historical Controls | The retrospective arm will consist of our control group, it will be derived from a retrospective medical chart review of all patients with CSDH at the facility. | |
| Prospective Arm | The prospective arm of the study will be looking at the effects of Dextrose 5% W/ Sodium Chloride 0.225% on the recurrence rate defined by the need for secondary surgical intervention for residual/recurrent CSDH) of CSDH in a 3-month post-operative window. Receives: Drug: Dextrose 5% W/ Sodium Chloride 0.225% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence Rate
We will see how many patients who are treated with D5 1/4NS have a recurrent episode of CSDH after their post-operative treatment.
Measured: Within 120 days (+/- 7 days) of their initial burr-hole surgery.
Secondary outcomes (1)
Rate of Volume Change of Residual CSDH Space
We will see how fast the brain volume expands after the administration of both NS and D5 1/4NS.
Measured: 24 (+/- 6 hours) hours post-operative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2019
- Study start17 Jan 2019
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Chronic 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carilion Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric A. Marvin, Carilion Clinic
- Investigators
- Eric Marvin, DO, Principal investigator, Carilion Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03831997
- Sponsor's protocol ID
- #2589
- Status last verified
- Nov 2026
- First submitted
- 4 Feb 2019
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alvis-Miranda HR, Castellar-Leones SM, Moscote-Salazar LR. Intravenous Fluid Therapy in Traumatic Brain Injury and Decompressive Craniectomy. Bull Emerg Trauma. 2014 Jan;2(1):3-14.
PubMed 27162857Balser D, Farooq S, Mehmood T, Reyes M, Samadani U. Actual and projected incidence rates for chronic subdural hematomas in United States Veterans Administration and civilian populations. J Neurosurg. 2015 Nov;123(5):1209-15. doi: 10.3171/2014.9.JNS141550. Epub 2015 Mar 20.
PubMed 25794342De Bonis P, Trevisi G, de Waure C, Sferrazza A, Volpe M, Pompucci A, Anile C, Mangiola A. Antiplatelet/anticoagulant agents and chronic subdural hematoma in the elderly. PLoS One. 2013 Jul 12;8(7):e68732. doi: 10.1371/journal.pone.0068732. Print 2013.
PubMed 23874740Dickerson RN, Maish GO 3rd, Weinberg JA, Croce MA, Minard G, Brown RO. Safety and efficacy of intravenous hypotonic 0.225% sodium chloride infusion for the treatment of hypernatremia in critically ill patients. Nutr Clin Pract. 2013 Jun;28(3):400-8. doi: 10.1177/0884533613483840. Epub 2013 Apr 22.
PubMed 23609478Edlmann E, Giorgi-Coll S, Whitfield PC, Carpenter KLH, Hutchinson PJ. Pathophysiology of chronic subdural haematoma: inflammation, angiogenesis and implications for pharmacotherapy. J Neuroinflammation. 2017 May 30;14(1):108. doi: 10.1186/s12974-017-0881-y.
PubMed 28558815Fedorov A, Beichel R, Kalpathy-Cramer J, Finet J, Fillion-Robin JC, Pujol S, Bauer C, Jennings D, Fennessy F, Sonka M, Buatti J, Aylward S, Miller JV, Pieper S, Kikinis R. 3D Slicer as an image computing platform for the Quantitative Imaging Network. Magn Reson Imaging. 2012 Nov;30(9):1323-41. doi: 10.1016/j.mri.2012.05.001. Epub 2012 Jul 6.
PubMed 22770690Feldman Z, Kanter MJ, Robertson CS, Contant CF, Hayes C, Sheinberg MA, Villareal CA, Narayan RK, Grossman RG. Effect of head elevation on intracranial pressure, cerebral perfusion pressure, and cerebral blood flow in head-injured patients. J Neurosurg. 1992 Feb;76(2):207-11. doi: 10.3171/jns.1992.76.2.0207.
PubMed 1730949Janowski M, Kunert P. Intravenous fluid administration may improve post-operative course of patients with chronic subdural hematoma: a retrospective study. PLoS One. 2012;7(4):e35634. doi: 10.1371/journal.pone.0035634. Epub 2012 Apr 20.
PubMed 22532865Kirk T, Jones K, Miller S, Corbett J. Measurement of intraocular and intracranial pressure: is there a relationship? Ann Neurol. 2011 Aug;70(2):323-6. doi: 10.1002/ana.22414. Epub 2011 Jun 27.
PubMed 21710618Komotar RJ, Starke RM, Connolly ES. The role of drain placement following chronic subdural hematoma evacuation. Neurosurgery. 2010 Feb;66(2):N15-6. doi: 10.1227/01.neu.0000367840.82764.3a. No abstract available.
PubMed 20087120Matsumoto H, Hanayama H, Okada T, Sakurai Y, Minami H, Masuda A, Tominaga S, Miyaji K, Yamaura I, Yoshida Y. Which surgical procedure is effective for refractory chronic subdural hematoma? Analysis of our surgical procedures and literature review. J Clin Neurosci. 2018 Mar;49:40-47. doi: 10.1016/j.jocn.2017.11.009. Epub 2017 Dec 20.
PubMed 29274740Montano N, Stifano V, Skrap B, Mazzucchi E. Management of residual subdural hematoma after burr-hole evacuation. The role of fluid therapy and review of the literature. J Clin Neurosci. 2017 Dec;46:26-29. doi: 10.1016/j.jocn.2017.08.041. Epub 2017 Sep 5.
PubMed 28887078Motiei-Langroudi R, Stippler M, Shi S, Adeeb N, Gupta R, Griessenauer CJ, Papavassiliou E, Kasper EM, Arle J, Alterman RL, Ogilvy CS, Thomas AJ. Factors predicting reoperation of chronic subdural hematoma following primary surgical evacuation. J Neurosurg. 2018 Nov 1;129(5):1143-1150. doi: 10.3171/2017.6.JNS17130. Epub 2017 Dec 15.
PubMed 29243977Oh HJ, Lee KS, Shim JJ, Yoon SM, Yun IG, Bae HG. Postoperative course and recurrence of chronic subdural hematoma. J Korean Neurosurg Soc. 2010 Dec;48(6):518-23. doi: 10.3340/jkns.2010.48.6.518. Epub 2010 Dec 31.
PubMed 21430978Prud'homme M, Mathieu F, Marcotte N, Cottin S. A Pilot Placebo Controlled Randomized Trial of Dexamethasone for Chronic Subdural Hematoma. Can J Neurol Sci. 2016 Mar;43(2):284-90. doi: 10.1017/cjn.2015.393. Epub 2016 Feb 8.
PubMed 26853325
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dextrose 5% in 0.225% Sodium Chloride (D5 1/4NS) on Postoperative Chronic Subdural Hematoma Size and Recurrence Rate
- ClinicalTrials.gov ID
- NCT03831997
- Acronym / sponsor ID
- #2589
- Conditions
- Chronic Subdural Hematoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Carilion ClinicUniversity, hospital or other
- Study start
- 17 Jan 2019 (actual)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 Jun 2030 (estimated)
- First posted
- 6 Feb 2019 (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 aims to reduce the recurrence rate of chronic subdural hematomas (CSDH) by manipulating the post-operative intravenous fluid use. The hypothesis relies on the relationship between osmolality and volume changes related to osmolality. We will be administering dextrose 5% in 1/4 normal saline (D5 1/4NS) post-operatively to induce brain expansion which can take up the residual CSDH space, to help reduce recurrence rate.
Detailed description
Chronic subdural hematoma (CSDH) is a neurological disease characterized by a collection of fluid, blood, and blood degradation matter between the arachnoid and dura mater in a well-developed membrane cavity. The presentation of this disease begins with minor head trauma and takes 4-7 weeks to become symptomatic.
One of the significant problems exists with CSDH is the rate of recurrence, which currently stands at a 7-30% rate worldwide. The recurrence of a CSDH is typically defined as the presence of residual or recurrent CSDH after the first resolution, leading to additional surgical intervention either within 3 months (early recurrence) or after 3 months (late recurrence). Additional surgical intervention (recurrence rate) is the outcome variable that our study will be looking at. Factors leading to persistent recurrence include age, use of anticoagulant therapy, volume of hematoma cavity, degree of midline shift on CT, presence of residual air post-operatively, and volume of residual hematoma fluid. The variability in surgeons' operative and post-operative care, which tries to address the multiple factors that lead to recurrence, illustrates the difficulty in trying to reduce postoperative recurrence. In fact, there is no postoperative standard of care. These variations in operative and postoperative care have yet to significantly decrease the recurrent rate of CSDH.
Given the health status and fragility of the patient population that is most commonly affected by CSDHs, and the inherent morbidity related to operating on this population, we hypothesize that D5 1/4NS can help mitigate the issue of residual/recurrence CSDH leading to subsequent surgeries. The fluid dynamics of D5 1/4NS have been studied and we can assume that it will facilitate brain re-expansion.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Historical Controls | – | –The retrospective arm will consist of our control group, it will be derived from a retrospective medical chart review of all patients with CSDH at the facility. |
| Prospective Arm | – | Drug: Dextrose 5% W/ Sodium Chloride 0.225%The prospective arm of the study will be looking at the effects of Dextrose 5% W/ Sodium Chloride 0.225% on the recurrence rate defined by the need for secondary surgical intervention for residual/recurrent CSDH) of CSDH in a 3-month post-operative window. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We will be recruiting patients (male, female; 18-60 years old) from our center, Carilion Roanoke Memorial Hospital, that have been diagnosed with CSDH necessitating burr-hole evacuation who fit our inclusion and exclusion criteria.
Key inclusion criteria (5 listed)
- Diagnosis of chronic subdural hematoma (based on imaging)
- Need for surgical intervention (assessed by attending neurosurgeon based on full neurological assessment)
- The procedure of choice is burr hole drainage
- Cessation of anti-coagulant therapy with accompanying normal lab values in appropriate time frames respective to the drug
- Tolerance of supine position
Key exclusion criteria (9 listed)
- <60 years old
- Presence of acute hemorrhage, stroke, or parenchymal damage
- Neurological deficits not accountable to mass effect
- Hyponatremia or inherent electrolyte imbalances
- Pregnancy or non-consentable patients
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 |
|---|---|---|
| Dextrose 5% W/ Sodium Chloride 0.225%Also: D5 1/4NSD5 1/4NS is comprised of 5% dextrose in a 0.225% sodium chloride (NaCl) solution. D5 1/4NS is initially slightly hypertonic to plasma, with an osmolarity of 321 mOSm/L. As the glucose component is rapidly metabolized, 0.225% NaCl solution remains and is hypotonic to plasma at an osmolarity of 77 mOsm/L. Because of the hypotonicity of the 1/4NS, it shifts into the intracellular compartments, followed by free water, and allows for volume expansion. | Drug | Prospective Arm |
Primary outcome
Recurrence Rate
Time frame: Within 120 days (+/- 7 days) of their initial burr-hole surgery.
We will see how many patients who are treated with D5 1/4NS have a recurrent episode of CSDH after their post-operative treatment.
1 secondary outcome
Rate of Volume Change of Residual CSDH Space
Time frame: 24 (+/- 6 hours) hours post-operative.
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 6 Nov 2026.
- Background: PubMed 27162857Alvis-Miranda HR, Castellar-Leones SM, Moscote-Salazar LR. Intravenous Fluid Therapy in Traumatic Brain Injury and Decompressive Craniectomy. Bull Emerg Trauma. 2014 Jan;2(1):3-14.
- Background: PubMed 25794342Balser D, Farooq S, Mehmood T, Reyes M, Samadani U. Actual and projected incidence rates for chronic subdural hematomas in United States Veterans Administration and civilian populations. J Neurosurg. 2015 Nov;123(5):1209-15. doi: 10.3171/2014.9.JNS141550. Epub 2015 Mar 20.
- Background: PubMed 23874740De Bonis P, Trevisi G, de Waure C, Sferrazza A, Volpe M, Pompucci A, Anile C, Mangiola A. Antiplatelet/anticoagulant agents and chronic subdural hematoma in the elderly. PLoS One. 2013 Jul 12;8(7):e68732. doi: 10.1371/journal.pone.0068732. Print 2013.
- Background: PubMed 23609478Dickerson RN, Maish GO 3rd, Weinberg JA, Croce MA, Minard G, Brown RO. Safety and efficacy of intravenous hypotonic 0.225% sodium chloride infusion for the treatment of hypernatremia in critically ill patients. Nutr Clin Pract. 2013 Jun;28(3):400-8. doi: 10.1177/0884533613483840. Epub 2013 Apr 22.
- Background: PubMed 28558815Edlmann E, Giorgi-Coll S, Whitfield PC, Carpenter KLH, Hutchinson PJ. Pathophysiology of chronic subdural haematoma: inflammation, angiogenesis and implications for pharmacotherapy. J Neuroinflammation. 2017 May 30;14(1):108. doi: 10.1186/s12974-017-0881-y.
- Background: PubMed 22770690Fedorov A, Beichel R, Kalpathy-Cramer J, Finet J, Fillion-Robin JC, Pujol S, Bauer C, Jennings D, Fennessy F, Sonka M, Buatti J, Aylward S, Miller JV, Pieper S, Kikinis R. 3D Slicer as an image computing platform for the Quantitative Imaging Network. Magn Reson Imaging. 2012 Nov;30(9):1323-41. doi: 10.1016/j.mri.2012.05.001. Epub 2012 Jul 6.
- Background: PubMed 1730949Feldman Z, Kanter MJ, Robertson CS, Contant CF, Hayes C, Sheinberg MA, Villareal CA, Narayan RK, Grossman RG. Effect of head elevation on intracranial pressure, cerebral perfusion pressure, and cerebral blood flow in head-injured patients. J Neurosurg. 1992 Feb;76(2):207-11. doi: 10.3171/jns.1992.76.2.0207.
- Background: PubMed 22532865Janowski M, Kunert P. Intravenous fluid administration may improve post-operative course of patients with chronic subdural hematoma: a retrospective study. PLoS One. 2012;7(4):e35634. doi: 10.1371/journal.pone.0035634. Epub 2012 Apr 20.
- Background: PubMed 21710618Kirk T, Jones K, Miller S, Corbett J. Measurement of intraocular and intracranial pressure: is there a relationship? Ann Neurol. 2011 Aug;70(2):323-6. doi: 10.1002/ana.22414. Epub 2011 Jun 27.
- Background: PubMed 20087120Komotar RJ, Starke RM, Connolly ES. The role of drain placement following chronic subdural hematoma evacuation. Neurosurgery. 2010 Feb;66(2):N15-6. doi: 10.1227/01.neu.0000367840.82764.3a. No abstract available.
- Background: PubMed 29274740Matsumoto H, Hanayama H, Okada T, Sakurai Y, Minami H, Masuda A, Tominaga S, Miyaji K, Yamaura I, Yoshida Y. Which surgical procedure is effective for refractory chronic subdural hematoma? Analysis of our surgical procedures and literature review. J Clin Neurosci. 2018 Mar;49:40-47. doi: 10.1016/j.jocn.2017.11.009. Epub 2017 Dec 20.
- Background: PubMed 28887078Montano N, Stifano V, Skrap B, Mazzucchi E. Management of residual subdural hematoma after burr-hole evacuation. The role of fluid therapy and review of the literature. J Clin Neurosci. 2017 Dec;46:26-29. doi: 10.1016/j.jocn.2017.08.041. Epub 2017 Sep 5.
- 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.
Eric Marvin, DO principal investigator
Carilion Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Subdural Hematoma, run by Carilion Clinic 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 5 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: looking for participants now, as of the sponsor's last update on 6 Nov 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 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.
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 Eric A Marvin, DO (5405889711, eamarvin@carilionclinic.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence Rate (time frame: Within 120 days (+/- 7 days) of their initial burr-hole surgery.). 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 NCT03831997, which also lists 20 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 6 Nov 2026.