Intracerebral HemorrhagePhase 1/2NCT02367248
Deferoxamine and Xingnaojing Injection Treatment in Intracerebral Hemorrhage
A Phase 1/2 study testing deferoxamine, Xingnaojing injection and Normal saline in people with Intracerebral Hemorrhage, run by Capital Medical University at 1 site in China.
Trial summary
The main purpose of this study is to determine whether deferoxamine and xingnaojing injection is effective and safe as a treatment for intracerebral hemorrhage. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intracerebral Hemorrhage
- What is being tested?
- deferoxamine, Xingnaojing injection and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- Mar 2015to Dec 2016
- Phase
- Phase 1/2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 and ≤ 80 years
- The diagnosis of ICH is confirmed by brain CT scan
- NIHSS score ≥ 6 and GCS > 6 upon presentation
- The first dose of the study drug can be administered within 12h of ICH symptom onset
- Functional independence prior to ICH, defined as pre-ICH mRS ≤ 1
- Signed and dated informed consent is obtained.
Who cannot join
- Known hypersensitivity to deferoxamine or xingnaojing injection
- Known severe iron deficiency anemia (defined as hemoglobin concentration < 7g/dL or requiring blood transfusions)
- Abnormal renal function, defined as serum creatinine > 2 mg/dL
- Planned surgical evacuation of ICH prior to administration of study drug
- Suspected secondary ICH related to tumour, ruptured aneurysm or arteriovenous malformation, hemorrhagic transformation of an ischemic infarct, or venous sinus thrombosis
- Infratentorial hemorrhage
Show all 16Show fewer
- Irreversibly impaired brainstem function (bilateral fixed and dilated pupils and extensor motor posturing)
- Complete unconsciousness, defined as a score of 3 on item 1a of the NIHSS (Responds only with reflex motor or autonomic effects or totally unresponsive, and flaccid)
- Pre-existing disability, defined as pre-ICH mRS ≥ 2
- Coagulopathy - defined as elevated aPTT or INR >1.3 upon presentation; concurrent use of direct thrombin inhibitors (such as dabigatran), direct factor Xa inhibitors (such as rivaroxaban), or low-molecular-weight heparin
- Taking iron supplements containing ≥ 325 mg of ferrous iron
- Patients with heart failure taking > 500 mg of vitamin C daily
- Known severe hearing loss
- Known pregnancy, or positive pregnancy test, or breastfeeding
- Patients known or suspected of not being able to comply with the study protocol due to alcoholism, drug dependency, noncompliance, living in another state or any other cause
- Life expectancy of less than 90 days due to comorbid conditions
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Neurology，Beijing Shijitan Hospital，Capital Medical University
Beijing, 100038
Maolin He, MD, 0086-010-63926550, maolinh@sina.com
About this study
Official title: Safety and Effectiveness Study of Deferoxamine and Xingnaojing Injection in Intracerebral Hemorrhage
The main purpose of this study is to determine whether deferoxamine and xingnaojing injection is effective and safe as a treatment for intracerebral hemorrhage.
Read the detailed description
Research shows that more than 1/3 of patients with acute cerebral hemorrhage in the first 24 hours will be expanding hematoma. The treatment of acute cerebral hemorrhage has two main targets: prevention of hematoma enlargement in primary brain damage; Reduce hematoma secondary brain damage caused by blood toxicity degradation products. At present, the curative effect of drug treatment of acute cerebral hemorrhage remains limited, using drug therapy to treat hematoma caused by blood toxicity degradation products secondary brain damage, is one of the main current international research direction and hotspot. Recent studies have found that iron overload in cells in acute cerebral hemorrhage stove weeks edema secondary lesion plays a very important role. Acute cerebral hemorrhage animal model research and small sample clinical study has shown that the iron chelator deferoxamine has good curative effect and security. Currently ongoing international HI-DEF test plans to assess the efficacy and safety of high-dose deferoxamine treatment within 24 h of patients with acute cerebral hemorrhage.
Basic research shows Xingnaojing injection can inhibit inflammatory reaction, scavenging free radicals, relieve acute cerebral hemorrhage hematoma surrounding edema and has a variety of brain protection mechanism. The current study builds on these results to assess the potential utility of deferoxamine and Xingnaojing injection as a therapeutic intervention in ICH.
This is a prospective, multi-center, double-blind, randomized, placebo-armed clinical study to test the safety and effectiveness of deferoxamine and Xingnaojing injection treatment in intracerebral hemorrhage. The investigators will randomize 180 subjects with ICH equally (1:1:1) to either DFO at 40mg/kg/day (up to a maximum daily dose of 6000 mg/day), or Xingnaojing injection, or saline placebo, given by continuous IV infusion for 5 consecutive days. Treatment will be initiated within 12 hours after ICH symptom onset.
The main objectives are:
- Examining the effects of DFO and Xingnaojing injection on peri-hematoma edema (PHE) volume progression between baseline and post-treatment CT/MRI scans and the residual cavity volume at 90 days.
- Obtaining data on the National Institute of Health Stroke Scale (NIHSS) to explore the effects of treatment on neurological functions.
- Examining the effects of DFO and Xingnaojing injection on biomarkers of acute cerebral hemorrhage such as ferritin, interleukin - 6, matrix metalloproteinase 9, tumor necrosis factor alpha and so on.
- Study the traditional Chinese medicine(TCM)curative effect evaluation of the roles of different treatment methods on secondary damage after ICH.
Secondary and exploratory objectives include:
- Exploring whether the effect of DFO on outcome is dependent on initial ICH volume, after adjusting for other prognostic variables, to determine if specific limits for ICH volume should be specified as exclusion/inclusion criteria for future studies.
- Exploring the differences between early (≤12h) and late (>12-24h) OTT windows in DFO treatment effect on functional outcome.
Exploratory study shows that iron chelator deferoxamine is effective and safe in the treatment of acute cerebral hemorrhage. We choose within 12 hours as the treatment time window, different from within 24 hours in the current international ongoing HI-DEF test. In theory, the earlier, the better curative effect. So this experiment is more likely to get a better curative effect. Xingnaojing injection is widely used in clinical in china, but lack of rigorous randomized controlled trial to prove its brain protection effect currently. Successful completion of this study will provide a crucial, reliable experimental evidence for a new treatment for acute cerebral hemorrhage. ICH is one of main causes of disability and death. A successful study demonstrating the efficacy of DFO and xingnaojing injection would be of considerable public health significance.
- Conditions
- Intracerebral Hemorrhage
- Being tested
- deferoxamine, Xingnaojing injection, Normal saline
- Keywords
- Brain hemorrhage, Cerebral Hemorrhage, Deferoxamine, Xingnaojing injection, Hematoma edema
- Medical subject headings
- Cerebral Hemorrhage, Intracranial Hemorrhages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
deferoxamineDrug
Also called Deferoxamine Mesylate
Deferoxamine mesylate(40 mg/kg/day up to a maximum daily dose of 6000 mg/day) given by a continuous IV infusion for 5 consecutive days beginning within 12 hours of ICH symptom onset.
Xingnaojing injectionDrug
Xingnaojing injection (20 ml/day) given by a continuous IV infusion for 5 consecutive days beginning within 12 hours of ICH symptom onset.
Normal salineDrug
Also called 0.90% Sodium Chloride Solution
This is a placebo. Normal saline will be given by a continuous IV infusion for 5 consecutive days beginning within 12 hours of ICH symptom onset.
| Study group | Role | What they receive |
|---|---|---|
| Deferoxamine | Active comparator | Deferoxamine mesylate supplied in vials containing 500 mg of sterile, lyophilized, powdered deferoxamine mesylate. The drug will be reconstituted for injection, by dissolving in 20 ml of sterile water. Receives: Drug: deferoxamine |
| Xingnaojing injection | Active comparator | Xingnaojing injection supplied in vials containing 20 ml liquid xingnaojing. Receives: Drug: Xingnaojing injection |
| Normal Saline | Placebo comparator | 0.9% sodium chloride Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numbers of patients with the perihematomal edema (PHE) volume variation.
decreases of more than 20% from initial PHE volumes were defined as "decreased" PHE volume; increases of more than 20% from initial PHE volumes were defined as "increased" PHE volume; changes between -20% and 20% were defined as "unchanged".
Measured: 7 days
Secondary outcomes (4)
The residual cavity volume
the variation of residual cavity volume of
Measured: 90 days
The variation of the mRS score and the Bathel Index
the variation of mRS score and Bathel Index of different treated subjects from ICH onset to treatment time windows.
Measured: 90 days
mortality
the mortality of different treated subjects from ICH onset to treatment time windows.
Measured: 90 days
Frequency of Treatment-related Adverse Events
The safety endpoints will include all DFO-related adverse events until day-7 or discharge (whichever is earlier), and DFO-related SAEs and through day-90.
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 posted20 Feb 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Intracerebral HemorrhageStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tiantan Hospital, Peking University First Hospital, People's Hospital of Beijing Daxing District, Beijing Haidian Hospital, The 263 Hospital of PLA, Beijing Aerospace General Hospital, Peking University Third Hospital, Beijing Pinggu District Hospital, Beijing Shuyi Hospital, General Hospital of Beijing PLA Military Region, Beijing Luhe Hospital, Beijing Fangshan District Liangxiang Hospital, Beijing Neurosurgical Institute, Beijing Jishuitan Hospital, Beijing Ditan Hospital, Beijing Youyi Hospital, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Peking University People's Hospital, The Second Artillery General Hospital, Chinese PLA General Hospital
- Responsible party
- Principal investigator, Maolin He, Capital Medical University
- Investigators
- Maolin He, MD, Principal investigator, Department of Neurology，Beijing Shijitan Hospital，Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02367248
- Sponsor's protocol ID
- MHe
- Status last verified
- May 2015
- First submitted
- 13 Feb 2015
- Last updated
- 18 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Okauchi M, Hua Y, Keep RF, Morgenstern LB, Schallert T, Xi G. Deferoxamine treatment for intracerebral hemorrhage in aged rats: therapeutic time window and optimal duration. Stroke. 2010 Feb;41(2):375-82. doi: 10.1161/STROKEAHA.109.569830. Epub 2009 Dec 31.
PubMed 20044521Selim M. Deferoxamine mesylate: a new hope for intracerebral hemorrhage: from bench to clinical trials. Stroke. 2009 Mar;40(3 Suppl):S90-1. doi: 10.1161/STROKEAHA.108.533125. Epub 2008 Dec 8.
PubMed 19064798Selim M, Yeatts S, Goldstein JN, Gomes J, Greenberg S, Morgenstern LB, Schlaug G, Torbey M, Waldman B, Xi G, Palesch Y; Deferoxamine Mesylate in Intracerebral Hemorrhage Investigators. Safety and tolerability of deferoxamine mesylate in patients with acute intracerebral hemorrhage. Stroke. 2011 Nov;42(11):3067-74. doi: 10.1161/STROKEAHA.111.617589. Epub 2011 Aug 25.
PubMed 21868742Morgenstern LB, Hemphill JC 3rd, Anderson C, Becker K, Broderick JP, Connolly ES Jr, Greenberg SM, Huang JN, MacDonald RL, Messe SR, Mitchell PH, Selim M, Tamargo RJ; American Heart Association Stroke Council and Council on Cardiovascular Nursing. Guidelines for the management of spontaneous intracerebral hemorrhage: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2010 Sep;41(9):2108-29. doi: 10.1161/STR.0b013e3181ec611b. Epub 2010 Jul 22.
PubMed 20651276Chaudhary N, Gemmete JJ, Thompson BG, Xi G, Pandey AS. Iron--potential therapeutic target in hemorrhagic stroke. World Neurosurg. 2013 Jan;79(1):7-9. doi: 10.1016/j.wneu.2012.11.048. Epub 2012 Nov 19. No abstract available.
PubMed 23174156Demchuk AM, Dowlatshahi D, Rodriguez-Luna D, Molina CA, Blas YS, Dzialowski I, Kobayashi A, Boulanger JM, Lum C, Gubitz G, Padma V, Roy J, Kase CS, Kosior J, Bhatia R, Tymchuk S, Subramaniam S, Gladstone DJ, Hill MD, Aviv RI; PREDICT/Sunnybrook ICH CTA study group. Prediction of haematoma growth and outcome in patients with intracerebral haemorrhage using the CT-angiography spot sign (PREDICT): a prospective observational study. Lancet Neurol. 2012 Apr;11(4):307-14. doi: 10.1016/S1474-4422(12)70038-8. Epub 2012 Mar 8.
PubMed 22405630Gu Y, Hua Y, Keep RF, Morgenstern LB, Xi G. Deferoxamine reduces intracerebral hematoma-induced iron accumulation and neuronal death in piglets. Stroke. 2009 Jun;40(6):2241-3. doi: 10.1161/STROKEAHA.108.539536. Epub 2009 Apr 16.
PubMed 19372448Okauchi M, Hua Y, Keep RF, Morgenstern LB, Xi G. Effects of deferoxamine on intracerebral hemorrhage-induced brain injury in aged rats. Stroke. 2009 May;40(5):1858-63. doi: 10.1161/STROKEAHA.108.535765. Epub 2009 Mar 12.
PubMed 19286595
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness Study of Deferoxamine and Xingnaojing Injection in Intracerebral Hemorrhage
- ClinicalTrials.gov ID
- NCT02367248
- Acronym / sponsor ID
- MHe
- Conditions
- Intracerebral Hemorrhage
- Keywords
- Brain hemorrhage, Cerebral Hemorrhage, Deferoxamine, Xingnaojing injection, Hematoma edema
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Collaborators
- Beijing Tiantan Hospital, Peking University First Hospital, People's Hospital of Beijing Daxing District, Beijing Haidian Hospital, The 263 Hospital of PLA, Beijing Aerospace General Hospital, Peking University Third Hospital, Beijing Pinggu District Hospital, Beijing Shuyi Hospital, General Hospital of Beijing PLA Military Region, Beijing Luhe Hospital, Beijing Fangshan District Liangxiang Hospital, Beijing Neurosurgical Institute, Beijing Jishuitan Hospital, Beijing Ditan Hospital, Beijing Youyi Hospital, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Peking University People's Hospital, The Second Artillery General Hospital, Chinese PLA General Hospital
- Study start
- Mar 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 20 Feb 2015 (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 main purpose of this study is to determine whether deferoxamine and xingnaojing injection is effective and safe as a treatment for intracerebral hemorrhage.
Detailed description
Research shows that more than 1/3 of patients with acute cerebral hemorrhage in the first 24 hours will be expanding hematoma. The treatment of acute cerebral hemorrhage has two main targets: prevention of hematoma enlargement in primary brain damage; Reduce hematoma secondary brain damage caused by blood toxicity degradation products. At present, the curative effect of drug treatment of acute cerebral hemorrhage remains limited, using drug therapy to treat hematoma caused by blood toxicity degradation products secondary brain damage, is one of the main current international research direction and hotspot. Recent studies have found that iron overload in cells in acute cerebral hemorrhage stove weeks edema secondary lesion plays a very important role. Acute cerebral hemorrhage animal model research and small sample clinical study has shown that the iron chelator deferoxamine has good curative effect and security. Currently ongoing international HI-DEF test plans to assess the efficacy and safety of high-dose deferoxamine treatment within 24 h of patients with acute cerebral hemorrhage.
Basic research shows Xingnaojing injection can inhibit inflammatory reaction, scavenging free radicals, relieve acute cerebral hemorrhage hematoma surrounding edema and has a variety of brain protection mechanism. The current study builds on these results to assess the potential utility of deferoxamine and Xingnaojing injection as a therapeutic intervention in ICH.
This is a prospective, multi-center, double-blind, randomized, placebo-armed clinical study to test the safety and effectiveness of deferoxamine and Xingnaojing injection treatment in intracerebral hemorrhage. The investigators will randomize 180 subjects with ICH equally (1:1:1) to either DFO at 40mg/kg/day (up to a maximum daily dose of 6000 mg/day), or Xingnaojing injection, or saline placebo, given by continuous IV infusion for 5 consecutive days. Treatment will be initiated within 12 hours after ICH symptom onset.
The main objectives are:
- Examining the effects of DFO and Xingnaojing injection on peri-hematoma edema (PHE) volume progression between baseline and post-treatment CT/MRI scans and the residual cavity volume at 90 days.
- Obtaining data on the National Institute of Health Stroke Scale (NIHSS) to explore the effects of treatment on neurological functions.
- Examining the effects of DFO and Xingnaojing injection on biomarkers of acute cerebral hemorrhage such as ferritin, interleukin - 6, matrix metalloproteinase 9, tumor necrosis factor alpha and so on.
- Study the traditional Chinese medicine(TCM)curative effect evaluation of the roles of different treatment methods on secondary damage after ICH.
Secondary and exploratory objectives include:
- Exploring whether the effect of DFO on outcome is dependent on initial ICH volume, after adjusting for other prognostic variables, to determine if specific limits for ICH volume should be specified as exclusion/inclusion criteria for future studies.
- Exploring the differences between early (≤12h) and late (>12-24h) OTT windows in DFO treatment effect on functional outcome.
Exploratory study shows that iron chelator deferoxamine is effective and safe in the treatment of acute cerebral hemorrhage. We choose within 12 hours as the treatment time window, different from within 24 hours in the current international ongoing HI-DEF test. In theory, the earlier, the better curative effect. So this experiment is more likely to get a better curative effect. Xingnaojing injection is widely used in clinical in china, but lack of rigorous randomized controlled trial to prove its brain protection effect currently. Successful completion of this study will provide a crucial, reliable experimental evidence for a new treatment for acute cerebral hemorrhage. ICH is one of main causes of disability and death. A successful study demonstrating the efficacy of DFO and xingnaojing injection would be of considerable public health significance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Deferoxamine | Active comparator | Drug: deferoxamineDeferoxamine mesylate supplied in vials containing 500 mg of sterile, lyophilized, powdered deferoxamine mesylate. The drug will be reconstituted for injection, by dissolving in 20 ml of sterile water. |
| Xingnaojing injection | Active comparator | Drug: Xingnaojing injectionXingnaojing injection supplied in vials containing 20 ml liquid xingnaojing. |
| Normal Saline | Placebo comparator | Drug: Normal saline0.9% sodium chloride |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 and ≤ 80 years
- The diagnosis of ICH is confirmed by brain CT scan
- NIHSS score ≥ 6 and GCS > 6 upon presentation
- The first dose of the study drug can be administered within 12h of ICH symptom onset
- Functional independence prior to ICH, defined as pre-ICH mRS ≤ 1
Key exclusion criteria (16 listed)
- Known hypersensitivity to deferoxamine or xingnaojing injection
- Known severe iron deficiency anemia (defined as hemoglobin concentration < 7g/dL or requiring blood transfusions)
- Abnormal renal function, defined as serum creatinine > 2 mg/dL
- Planned surgical evacuation of ICH prior to administration of study drug
- Suspected secondary ICH related to tumour, ruptured aneurysm or arteriovenous malformation, hemorrhagic transformation of an ischemic infarct, or venous sinus thrombosis
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 |
|---|---|---|
| deferoxamineAlso: Deferoxamine MesylateDeferoxamine mesylate(40 mg/kg/day up to a maximum daily dose of 6000 mg/day) given by a continuous IV infusion for 5 consecutive days beginning within 12 hours of ICH symptom onset. | Drug | Deferoxamine |
| Xingnaojing injectionXingnaojing injection (20 ml/day) given by a continuous IV infusion for 5 consecutive days beginning within 12 hours of ICH symptom onset. | Drug | Xingnaojing injection |
| Normal salineAlso: 0.90% Sodium Chloride SolutionThis is a placebo. Normal saline will be given by a continuous IV infusion for 5 consecutive days beginning within 12 hours of ICH symptom onset. | Drug | Normal Saline |
Primary outcome
Numbers of patients with the perihematomal edema (PHE) volume variation.
Time frame: 7 days
decreases of more than 20% from initial PHE volumes were defined as "decreased" PHE volume; increases of more than 20% from initial PHE volumes were defined as "increased" PHE volume; changes between -20% and 20% were defined as "unchanged".
4 secondary outcomes
The residual cavity volume
Time frame: 90 days
The variation of the mRS score and the Bathel Index
Time frame: 90 days
mortality
Time frame: 90 days
Frequency of Treatment-related Adverse Events
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2015.
- Background: PubMed 20044521Okauchi M, Hua Y, Keep RF, Morgenstern LB, Schallert T, Xi G. Deferoxamine treatment for intracerebral hemorrhage in aged rats: therapeutic time window and optimal duration. Stroke. 2010 Feb;41(2):375-82. doi: 10.1161/STROKEAHA.109.569830. Epub 2009 Dec 31.
- Background: PubMed 19064798Selim M. Deferoxamine mesylate: a new hope for intracerebral hemorrhage: from bench to clinical trials. Stroke. 2009 Mar;40(3 Suppl):S90-1. doi: 10.1161/STROKEAHA.108.533125. Epub 2008 Dec 8.
- Background: PubMed 21868742Selim M, Yeatts S, Goldstein JN, Gomes J, Greenberg S, Morgenstern LB, Schlaug G, Torbey M, Waldman B, Xi G, Palesch Y; Deferoxamine Mesylate in Intracerebral Hemorrhage Investigators. Safety and tolerability of deferoxamine mesylate in patients with acute intracerebral hemorrhage. Stroke. 2011 Nov;42(11):3067-74. doi: 10.1161/STROKEAHA.111.617589. Epub 2011 Aug 25.
- Background: PubMed 20651276Morgenstern LB, Hemphill JC 3rd, Anderson C, Becker K, Broderick JP, Connolly ES Jr, Greenberg SM, Huang JN, MacDonald RL, Messe SR, Mitchell PH, Selim M, Tamargo RJ; American Heart Association Stroke Council and Council on Cardiovascular Nursing. Guidelines for the management of spontaneous intracerebral hemorrhage: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2010 Sep;41(9):2108-29. doi: 10.1161/STR.0b013e3181ec611b. Epub 2010 Jul 22.
- Background: PubMed 23174156Chaudhary N, Gemmete JJ, Thompson BG, Xi G, Pandey AS. Iron--potential therapeutic target in hemorrhagic stroke. World Neurosurg. 2013 Jan;79(1):7-9. doi: 10.1016/j.wneu.2012.11.048. Epub 2012 Nov 19. No abstract available.
- Background: PubMed 22405630Demchuk AM, Dowlatshahi D, Rodriguez-Luna D, Molina CA, Blas YS, Dzialowski I, Kobayashi A, Boulanger JM, Lum C, Gubitz G, Padma V, Roy J, Kase CS, Kosior J, Bhatia R, Tymchuk S, Subramaniam S, Gladstone DJ, Hill MD, Aviv RI; PREDICT/Sunnybrook ICH CTA study group. Prediction of haematoma growth and outcome in patients with intracerebral haemorrhage using the CT-angiography spot sign (PREDICT): a prospective observational study. Lancet Neurol. 2012 Apr;11(4):307-14. doi: 10.1016/S1474-4422(12)70038-8. Epub 2012 Mar 8.
- Background: PubMed 19372448Gu Y, Hua Y, Keep RF, Morgenstern LB, Xi G. Deferoxamine reduces intracerebral hematoma-induced iron accumulation and neuronal death in piglets. Stroke. 2009 Jun;40(6):2241-3. doi: 10.1161/STROKEAHA.108.539536. Epub 2009 Apr 16.
- Background: PubMed 19286595Okauchi M, Hua Y, Keep RF, Morgenstern LB, Xi G. Effects of deferoxamine on intracerebral hemorrhage-induced brain injury in aged rats. Stroke. 2009 May;40(5):1858-63. doi: 10.1161/STROKEAHA.108.535765. Epub 2009 Mar 12.
Related trials for Intracerebral Hemorrhage
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
RecruitingObservational study
Smartphone Enabled Detection of Cognitive Motor Dissociation in the ICU
Traumatic Brain Injury (TBI) Patients, Intracerebral Hemorrhage
Not yet recruitingObservational study
Integrating Wearable Monitoring and Clinical Data for Stroke Early Warning
Stroke, Ischemic Stroke
Recruiting
Stereotactic Thrombolysis With Tenecteplase for Supratentorial Intracerebral Hemorrhage
Intracerebral Haemorrhage, Minimally Invasive Treatment
RecruitingObservational study
Sleep to Predict Recovery In Unconscious Patients With Acute Brain Injury
Traumatic Brain Injury (TBI) Patients, Intracerebral Hemorrhage (ICH)
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.
Maolin He, MD principal investigator
Department of Neurology，Beijing Shijitan Hospital，Capital Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing deferoxamine, Xingnaojing injection and Normal saline in people with Intracerebral Hemorrhage, run by Capital Medical University at 1 site in China.
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 6 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: status not confirmed, as of the sponsor's last update on 18 May 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 China. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maolin He, MD (0086-010-63926550, maolinh@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numbers of patients with the perihematomal edema (PHE) volume variation. (time frame: 7 days). 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 NCT02367248, which also lists 8 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 18 May 2015.