Subarachnoid HemorrhageEarly Phase 1NCT02216513
Deferoxamine to Prevent Delayed Cerebral Ischemia After Subarachnoid Hemorrhage
A Early Phase 1 study testing desferrioxamine (DFO) in people with Subarachnoid Hemorrhage, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The investigators will test the central hypothesis that DFO treatment after SAH may improve cerebrovascular regulation, mitigate ischemic neural injury, and serve as an effective neuroprotectant against delayed ischemic injury after SAH. 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?
- desferrioxamine (DFO)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Jul 2015
- Phase
- Early Phase 1
- 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
- diagnosis of spontaneous SAH
- impaired cerebral autoregulation on day 2-4 post SAH
Who cannot join
- traumatic SAH
- other central neurological disorders such as tumors, known prior stroke, hemorrhage or vascular malformations
- pregnancy
- severe renal disease or anuria
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Deferoxamine: An Emerging Therapy to Prevent Delayed Cerebral Ischemia After Subarachnoid Hemorrhage
The investigators will test the central hypothesis that DFO treatment after SAH may improve cerebrovascular regulation, mitigate ischemic neural injury, and serve as an effective neuroprotectant against delayed ischemic injury after SAH.
- Conditions
- Subarachnoid Hemorrhage
- Being tested
- desferrioxamine (DFO), placebo
- Keywords
- subarachnoid hemorrhage, SAH, DFO, cerebral autoregulation, delayed cerebral ischemia
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
desferrioxamine (DFO)Drug
Also called deferoxamine, desferal, DFO, deferoxamine mesylate
DFO (20mg/kg/hr) in normal saline for 4 hours for 5 consecutive days
placeboDrug
Also called normal saline NS
normal saline IV for 4 hours for 5 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| Desferrioxamine (DFO) | Active comparator | DFO (20mg/kg/hr) in normal saline IV for 4 hours for 5 consecutive days Receives: Drug: desferrioxamine (DFO) |
| placebo | Placebo comparator | normal saline IV for 4 hours for 5 consecutive days Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
delayed cerebral ischemia (DCI)
DCI will be defined radiographically as any cerebral infarct on the latest CT scan that was seen within 6 weeks after SAH or before discharge or death, that was not present on admission scan or on the CT scan done within 24 to 48 hours after any aneurysmal treatment procedures. All head CT scans will be reviewed for DCI ascertainment by neuroradiologists blinded to the clinical and TCD data using the standardized protocol.
Measured: 6 weeks post hemorrhage
Secondary outcomes (1)
Clinical outcome at discharge
Clinical outcome at discharge will be assessed using modified Rankin Scale (mRS) as a global functional status. The modified Rankin scale evaluates global disability and handicap; scores range from 0 (no symptoms or disability) to 6 (death). Good mRS will be defined as score of ≤ 2.
Measured: patient's discharge date, which averages 3-4 weeks post hemorrhage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionJun 2015
- Study completionJul 2015
Why it stopped: Principle Investigator is moving to another institution and plans to restart this proctocol in the new location.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 Brigham and Women's 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Jeffrey Thomas Stroke Shield Foundation
- Responsible party
- Principal investigator, Farzaneh Sorond, Brigham and Women's Hospital
- Investigators
- Farzaneh A Sorond, MD, PhD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02216513
- Sponsor's protocol ID
- 2014P001400
- Status last verified
- Jul 2015
- First submitted
- 6 Aug 2014
- Last updated
- 21 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Van der Loo LE, Aquarius R, Teernstra O, Klijn K, Menovsky T, van Dijk JMC, Bartels R, Boogaarts HD. Iron chelators for acute stroke. Cochrane Database Syst Rev. 2020 Nov 24;11(11):CD009280. doi: 10.1002/14651858.CD009280.pub3.
PubMed 33236783
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deferoxamine: An Emerging Therapy to Prevent Delayed Cerebral Ischemia After Subarachnoid Hemorrhage
- ClinicalTrials.gov ID
- NCT02216513
- Acronym / sponsor ID
- 2014P001400
- Conditions
- Subarachnoid Hemorrhage
- Keywords
- subarachnoid hemorrhage, SAH, DFO, cerebral autoregulation, delayed cerebral ischemia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Principle Investigator is moving to another institution and plans to restart this proctocol in the new location.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Dr. Jeffrey Thomas Stroke Shield Foundation
- Study start
- Sep 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 15 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will test the central hypothesis that DFO treatment after SAH may improve cerebrovascular regulation, mitigate ischemic neural injury, and serve as an effective neuroprotectant against delayed ischemic injury after SAH.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Desferrioxamine (DFO) | Active comparator | Drug: desferrioxamine (DFO)DFO (20mg/kg/hr) in normal saline IV for 4 hours for 5 consecutive days |
| placebo | Placebo comparator | Drug: placebonormal saline IV for 4 hours for 5 consecutive days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- diagnosis of spontaneous SAH
- impaired cerebral autoregulation on day 2-4 post SAH
Key exclusion criteria (4 listed)
- traumatic SAH
- other central neurological disorders such as tumors, known prior stroke, hemorrhage or vascular malformations
- pregnancy
- severe renal disease or anuria
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 |
|---|---|---|
| desferrioxamine (DFO)Also: deferoxamine, desferal, DFO, deferoxamine mesylateDFO (20mg/kg/hr) in normal saline for 4 hours for 5 consecutive days | Drug | Desferrioxamine (DFO) |
| placeboAlso: normal saline NSnormal saline IV for 4 hours for 5 consecutive days | Drug | placebo |
Primary outcome
delayed cerebral ischemia (DCI)
Time frame: 6 weeks post hemorrhage
DCI will be defined radiographically as any cerebral infarct on the latest CT scan that was seen within 6 weeks after SAH or before discharge or death, that was not present on admission scan or on the CT scan done within 24 to 48 hours after any aneurysmal treatment procedures. All head CT scans will be reviewed for DCI ascertainment by neuroradiologists blinded to the clinical and TCD data using the standardized protocol.
1 secondary outcome
Clinical outcome at discharge
Time frame: patient's discharge date, which averages 3-4 weeks post hemorrhage
Results and safety
The study was stopped early (reason given: Principle Investigator is moving to another institution and plans to restart this proctocol in the new location.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2015.
- Derived from this study: PubMed 33236783Van der Loo LE, Aquarius R, Teernstra O, Klijn K, Menovsky T, van Dijk JMC, Bartels R, Boogaarts HD. Iron chelators for acute stroke. Cochrane Database Syst Rev. 2020 Nov 24;11(11):CD009280. doi: 10.1002/14651858.CD009280.pub3.
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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.
Farzaneh A Sorond, MD, PhD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing desferrioxamine (DFO) in people with Subarachnoid Hemorrhage, run by Brigham and Women's Hospital 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 2 inclusion and 4 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: stopped early, as of the sponsor's last update on 21 Jul 2015. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 was stopped early (reason given: Principle Investigator is moving to another institution and plans to restart this proctocol in the new location.). Results are not available in the source record.
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?
delayed cerebral ischemia (DCI) (time frame: 6 weeks post hemorrhage). 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 NCT02216513, which also lists 1 linked publication.
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 21 Jul 2015.