Intracerebral HemorrhageNCT02054117
Association Between Haptoglobin Genotype and Brain Swelling
An observational study of Intracerebral Hemorrhage, run by University of Florida at 1 site in United States.
Trial summary
Intracerebral hemorrhage is bleeding into the brain and is a major cause of stroke and other complications. Brain injury from intracerebral hemorrhage occurs in two phases. The early phase involves the mechanical compression of brain tissue by the expanding hematoma. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Intracerebral Hemorrhage
- What is being tested?
- Intracerebral Hemorrhage
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Mar 2015
- Phase
- Observational
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be recruited from within the hospital setting.
Who may be able to join
- Spontaneous intracranial or intraparenchymal hemorrhage
- 18-85 years of age
- Hemorrhage occurred in a supratentorial location
Who cannot join
- Inability to obtain consent within 3 days of hemorrhage onset
- Known pregnancy
- Therapeutic anticoagulation with Lovenox, Coumadin or Heparin
- Prior history of therapeutic radiation to any area
- Brain tumor
- Hemorrhage related to trauma, aneurysm, arteriovenous malformation or other vascular malformation
Show all 12Show fewer
- Central nervous system infection
- Subdural hematoma
- Subarachnoid hemorrhage
- Chronic immunosuppression, including steroids or chemotherapy agents
- Infratentorial location
- Unable to obtain MRI due to mental status or other contraindication (metal, pacemaker, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association Between Haptoglobin Genotype and the Development of Perihematomal Edema After Spontaneous Intracerebral Hemorrhage
Intracerebral hemorrhage is bleeding into the brain and is a major cause of stroke and other complications. Brain injury from intracerebral hemorrhage occurs in two phases. The early phase involves the mechanical compression of brain tissue by the expanding hematoma. In a later phase, brain swelling develops causing further compression that may lead to brain herniation and death. This study investigates the neuroprotective role of haptoglobin, in minimizing the development of brain swelling following intracerebral hemorrhage.
Read the detailed description
Intracerebral hemorrhage is bleeding into the brain parenchyma. It is a major cause of stroke, and is associated with significant morbidity and mortality. Brain injury from intracerebral hemorrhage occurs in two phases. The early phase involves the mechanical compression of brain tissue by the expanding hematoma. In a later phase, brain edema, especially perihematomal edema, develops causing further compression that may lead to brain herniation and death. Several factors are implicated in the development of brain edema, including inflammation resulting from the oxidative stress caused by iron-rich hemoglobin released from lysed erythrocytes in brain tissue. This study investigates the neuroprotective role of an acute phase reactant, haptoglobin, in minimizing the development of perihematomal edema following intracerebral hemorrhage. This protein protects brain tissue from hemoglobin degradation products by forming haptoglobin-hemoglobin complexes that are subsequently cleared by the spleen. Notably, different alleles of haptoglobin exist in humans, with varying affinities for hemoglobin. Investigating the association between the different alleles and the degree of perihematomal edema formation is the primary goal of this study. The investigators will also look at a marker of inflammation, matrix metalloproteinases, and analyze its level of expression in subjects with different alleles of haptoglobin.
- Conditions
- Intracerebral Hemorrhage
- Being tested
- Intracerebral Hemorrhage
- Keywords
- Hemorrhage, Intracerebral hemorrhage (ICH)
- Medical subject headings
- Cerebral Hemorrhage, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracerebral HemorrhageOther
Also called Spontaneious intracranial hemorrhage, Intraparenchymal hemorrhage
Spontaneous intracranial or intraparenchymal hemorrhage that occurred in a supratentorial location.
| Study group | Role | What they receive |
|---|---|---|
| Intracerebral Hemorrhage | Spontaneous intracranial or intraparenchymal hemorrhage that occurred in a supratentorial location. Receives: Other: Intracerebral Hemorrhage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perihematomal Edema Volume
Perihematomal edema will be measured by averaging the edema area over multiple slices and subtracting the hemorrhage area from the total lesion area.
Measured: Post-hemmorhage day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2014 (estimated)
- Study startMar 2014
- Primary completionMar 2015
- Study completionMar 2015
Why it stopped: Principal Investigator is leaving institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracerebral HemorrhageStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Spiros Blackburn, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02054117
- Sponsor's protocol ID
- 201300797
- Status last verified
- Mar 2015
- First submitted
- 3 Feb 2014
- Last updated
- 5 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Haptoglobin Genotype and the Development of Perihematomal Edema After Spontaneous Intracerebral Hemorrhage
- ClinicalTrials.gov ID
- NCT02054117
- Acronym / sponsor ID
- 201300797
- Conditions
- Intracerebral Hemorrhage
- Keywords
- Hemorrhage, Intracerebral hemorrhage (ICH)
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Principal Investigator is leaving institution.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 4 Feb 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.
Intracerebral hemorrhage is bleeding into the brain and is a major cause of stroke and other complications. Brain injury from intracerebral hemorrhage occurs in two phases. The early phase involves the mechanical compression of brain tissue by the expanding hematoma. In a later phase, brain swelling develops causing further compression that may lead to brain herniation and death. This study investigates the neuroprotective role of haptoglobin, in minimizing the development of brain swelling following intracerebral hemorrhage.
Detailed description
Intracerebral hemorrhage is bleeding into the brain parenchyma. It is a major cause of stroke, and is associated with significant morbidity and mortality. Brain injury from intracerebral hemorrhage occurs in two phases. The early phase involves the mechanical compression of brain tissue by the expanding hematoma. In a later phase, brain edema, especially perihematomal edema, develops causing further compression that may lead to brain herniation and death. Several factors are implicated in the development of brain edema, including inflammation resulting from the oxidative stress caused by iron-rich hemoglobin released from lysed erythrocytes in brain tissue. This study investigates the neuroprotective role of an acute phase reactant, haptoglobin, in minimizing the development of perihematomal edema following intracerebral hemorrhage. This protein protects brain tissue from hemoglobin degradation products by forming haptoglobin-hemoglobin complexes that are subsequently cleared by the spleen. Notably, different alleles of haptoglobin exist in humans, with varying affinities for hemoglobin. Investigating the association between the different alleles and the degree of perihematomal edema formation is the primary goal of this study. The investigators will also look at a marker of inflammation, matrix metalloproteinases, and analyze its level of expression in subjects with different alleles of haptoglobin.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intracerebral Hemorrhage | – | Other: Intracerebral HemorrhageSpontaneous intracranial or intraparenchymal hemorrhage that occurred in a supratentorial location. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from within the hospital setting.
Key inclusion criteria (3 listed)
- Spontaneous intracranial or intraparenchymal hemorrhage
- 18-85 years of age
- Hemorrhage occurred in a supratentorial location
Key exclusion criteria (12 listed)
- Inability to obtain consent within 3 days of hemorrhage onset
- Known pregnancy
- Therapeutic anticoagulation with Lovenox, Coumadin or Heparin
- Prior history of therapeutic radiation to any area
- Brain tumor
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 |
|---|---|---|
| Intracerebral HemorrhageAlso: Spontaneious intracranial hemorrhage, Intraparenchymal hemorrhageSpontaneous intracranial or intraparenchymal hemorrhage that occurred in a supratentorial location. | Other | Intracerebral Hemorrhage |
Primary outcome
Perihematomal Edema Volume
Time frame: Post-hemmorhage day 3
Perihematomal edema will be measured by averaging the edema area over multiple slices and subtracting the hemorrhage area from the total lesion area.
Results and safety
The study was stopped early (reason given: Principal Investigator is leaving institution.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2015.
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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.
Spiros Blackburn, MD principal investigator
University of Florida
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 Intracerebral Hemorrhage, run by University of Florida 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 12 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 5 Mar 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. 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?
The study was stopped early (reason given: Principal Investigator is leaving institution.). 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?
Perihematomal Edema Volume (time frame: Post-hemmorhage day 3). 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 5 Mar 2015.