Intracranial HemorrhagesCARICHNCT02135783
Decompressive Craniectomy Combined With Hematoma Removal to Treat ICH
A study testing Decompressive Craniectomy and non-Decompressive Craniectomy in people with Intracranial Hemorrhages, run by Southwest Hospital, China at 1 site in China.
Trial summary
Decompressive craniectomy has been reported for the treatment of patients with intracerebral hemorrhage. But no prospective randomised controlled trials have yet been undertaken to confirm its effect.The purpose of the study is to determine whether decompressive craniectomy post hematoma removal surgery after… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intracranial Hemorrhages
- What is being tested?
- Decompressive Craniectomy and non-Decompressive Craniectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Oct 2014to Oct 2018
- Phase
- Interventional
- 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
- Evidence of a spontaneous lobar and basal ganglia ICH on CT scan
- Patient within 72 hours of ictus
- Best score on the GCS of 5-13.
- Volume of hematoma between 30 and 100ml [Calculated using (a x b x c)/2 method]
- The history of hypertensive
Who cannot join
- Clear evidence that the hemorrhage is due to an aneurysm or angiographically proven arteriovenous malformation.
- Intraventricular hemorrhage of any sort
- ICH secondary to tumour or trauma.
- If the hematological effects of any previous anticoagulants are not completely reversed.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Neurosurgery , Southwest Hospital, Third Military Medical University,
Chongqing
Rong Hu, MD, +8615123917123, huchrong@aliyun.com
Rong Hu, MD PHD
About this study
Official title: A Randomised Trial to Establish the Efficacy and Safety of Decompressive Craniectomy Combined With Hematoma Removal in Patients With Intracerebral Hemorrhage
Decompressive craniectomy has been reported for the treatment of patients with intracerebral hemorrhage. But no prospective randomised controlled trials have yet been undertaken to confirm its effect.The purpose of the study is to determine whether decompressive craniectomy post hematoma removal surgery after intracerebral hemorrhage will reduce the chances of a person dying or surviving with a long term disability.
Read the detailed description
Intracerebral hemorrhage (ICH) is one of the most serious subtypes of stroke, affecting approximately 2-3 million people worldwide each year. About one third of people with ICH die early after onset and the majority of survivors are left with major long-term disability. Hematoma removal (HR) surgery is the primary treatment for ICH which volume is more than 30ml. But whether decompressive craniectomy (DC) should be employed during the HR surgery still has considerable controversy. Outcomes in this study will be measured at 3 months after surgery via a postal questionnaire including the Glasgow Outcome scale, Modified Rankin Scale, and Barthel index. Two hundred patients will be recruited to the trial over 36 months. Follow-up will take three months with analysis and reporting taking one year.
- Conditions
- Intracranial Hemorrhages
- Being tested
- Decompressive Craniectomy, non-Decompressive Craniectomy
- Medical subject headings
- Intracranial Hemorrhages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decompressive CraniectomyProcedure or surgery
A portion of frontal,temporal, and parietal bone was removed by craniectomy and the size of decompression was about 10x12 cm2.Intracerebral hematoma was evacuated by transcortical approach with the aid of a surgical microscope.
non-Decompressive CraniectomyProcedure or surgery
a simple hematoma removal by osteoplastic craniotomy group (HR) or Intracerebral hematoma was evacuated by transcortical approach with the aid of a surgical neuroendoscopyand the size of decompression was about 3x2.5 cm2.
| Study group | Role | What they receive |
|---|---|---|
| Decompressive Craniectomy | Experimental | Decompressive Craniectomy afte Hematoma Removal in Patients with Intracerebral Hemorrhage Receives: Procedure: Decompressive Craniectomy |
| non-Decompressive Craniectomy | Active comparator | non-Decompressive Craniectomy afte Hematoma Removal in Patients with Intracerebral Hemorrhage Receives: Procedure: non-Decompressive Craniectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality and disability
according to a 3-6 scores on the modified Rankin Score
Measured: 3 months
Secondary outcomes (1)
Occurrence of second Surgery
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2017 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intracranial HemorrhagesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southwest Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rong Hu, Southwest Hospital, China
- Investigators
- Rong Hu, MD,PhD, Principal investigator, Department of Neurosurgery, Southwest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02135783
- Sponsor's protocol ID
- Neurosurg 01
- Acronym
- CARICH
- Status last verified
- Feb 2016
- First submitted
- 7 May 2014
- Last updated
- 5 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zhang C, Zhang S, Yin Y, Wang L, Li L, Lan C, Shi J, Jiang Z, Ge H, Li X, Ao Z, Hu S, Chen J, Feng H, Hu R. Clot removAl with or without decompRessive craniectomy under ICP monitoring for supratentorial IntraCerebral Hemorrhage (CARICH): a randomized controlled trial. Int J Surg. 2024 Aug 1;110(8):4804-4809. doi: 10.1097/JS9.0000000000001466.
PubMed 38640513Hu R, Zhang C, Xia J, Ge H, Zhong J, Fang X, Zou Y, Lan C, Li L, Feng H. Long-term Outcomes and Risk Factors Related to Hydrocephalus After Intracerebral Hemorrhage. Transl Stroke Res. 2021 Feb;12(1):31-38. doi: 10.1007/s12975-020-00823-y. Epub 2020 Jun 8.
PubMed 32514905
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Trial to Establish the Efficacy and Safety of Decompressive Craniectomy Combined With Hematoma Removal in Patients With Intracerebral Hemorrhage
- ClinicalTrials.gov ID
- NCT02135783
- Acronym / sponsor ID
- CARICH / Neurosurg 01
- Conditions
- Intracranial Hemorrhages
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Southwest Hospital, ChinaUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 12 May 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.
Decompressive craniectomy has been reported for the treatment of patients with intracerebral hemorrhage. But no prospective randomised controlled trials have yet been undertaken to confirm its effect.The purpose of the study is to determine whether decompressive craniectomy post hematoma removal surgery after intracerebral hemorrhage will reduce the chances of a person dying or surviving with a long term disability.
Detailed description
Intracerebral hemorrhage (ICH) is one of the most serious subtypes of stroke, affecting approximately 2-3 million people worldwide each year. About one third of people with ICH die early after onset and the majority of survivors are left with major long-term disability. Hematoma removal (HR) surgery is the primary treatment for ICH which volume is more than 30ml. But whether decompressive craniectomy (DC) should be employed during the HR surgery still has considerable controversy. Outcomes in this study will be measured at 3 months after surgery via a postal questionnaire including the Glasgow Outcome scale, Modified Rankin Scale, and Barthel index. Two hundred patients will be recruited to the trial over 36 months. Follow-up will take three months with analysis and reporting taking one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Decompressive Craniectomy | Experimental | Procedure: Decompressive CraniectomyDecompressive Craniectomy afte Hematoma Removal in Patients with Intracerebral Hemorrhage |
| non-Decompressive Craniectomy | Active comparator | Procedure: non-Decompressive Craniectomynon-Decompressive Craniectomy afte Hematoma Removal in Patients with Intracerebral Hemorrhage |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Evidence of a spontaneous lobar and basal ganglia ICH on CT scan
- Patient within 72 hours of ictus
- Best score on the GCS of 5-13.
- Volume of hematoma between 30 and 100ml [Calculated using (a x b x c)/2 method]
- The history of hypertensive
Key exclusion criteria (4 listed)
- Clear evidence that the hemorrhage is due to an aneurysm or angiographically proven arteriovenous malformation.
- Intraventricular hemorrhage of any sort
- ICH secondary to tumour or trauma.
- If the hematological effects of any previous anticoagulants are not completely reversed.
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 |
|---|---|---|
| Decompressive CraniectomyA portion of frontal,temporal, and parietal bone was removed by craniectomy and the size of decompression was about 10x12 cm2.Intracerebral hematoma was evacuated by transcortical approach with the aid of a surgical microscope. | Procedure or surgery | Decompressive Craniectomy |
| non-Decompressive Craniectomya simple hematoma removal by osteoplastic craniotomy group (HR) or Intracerebral hematoma was evacuated by transcortical approach with the aid of a surgical neuroendoscopyand the size of decompression was about 3x2.5 cm2. | Procedure or surgery | non-Decompressive Craniectomy |
Primary outcome
Mortality and disability
Time frame: 3 months
according to a 3-6 scores on the modified Rankin Score
1 secondary outcome
Occurrence of second Surgery
Time frame: 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2016.
- Derived from this study: PubMed 38640513Zhang C, Zhang S, Yin Y, Wang L, Li L, Lan C, Shi J, Jiang Z, Ge H, Li X, Ao Z, Hu S, Chen J, Feng H, Hu R. Clot removAl with or without decompRessive craniectomy under ICP monitoring for supratentorial IntraCerebral Hemorrhage (CARICH): a randomized controlled trial. Int J Surg. 2024 Aug 1;110(8):4804-4809. doi: 10.1097/JS9.0000000000001466.
- Derived from this study: PubMed 32514905Hu R, Zhang C, Xia J, Ge H, Zhong J, Fang X, Zou Y, Lan C, Li L, Feng H. Long-term Outcomes and Risk Factors Related to Hydrocephalus After Intracerebral Hemorrhage. Transl Stroke Res. 2021 Feb;12(1):31-38. doi: 10.1007/s12975-020-00823-y. Epub 2020 Jun 8.
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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.
Department of Neurosurgery , Southwest Hospital, Third Military Medical University,
Chongqing, China
Rong Hu, MD,PhD principal investigator
Department of Neurosurgery, Southwest Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decompressive Craniectomy and non-Decompressive Craniectomy in people with Intracranial Hemorrhages, run by Southwest Hospital, China 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 5 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: status not confirmed, as of the sponsor's last update on 5 Feb 2016. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality and disability (time frame: 3 months). 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 NCT02135783, which also lists 2 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 5 Feb 2016.