Carotid Artery InjuryNCT00494156
Anticoagulation in Blunt Cerebrovascular Injuries
A study testing heparin and aspirin and clopidogrel in people with Carotid Artery Injury and Vertebral Artery Injury, run by C. Clay Cothren, MD at 1 site in United States.
Trial summary
Originally thought to be a rare occurrence, BCVI are now diagnosed in approximately 1% of blunt trauma patients. Initially BCVI were thought to have unavoidable devastating neurologic outcomes. But early reports suggested anticoagulation might decrease these events. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Artery Injury, Vertebral Artery Injury
- What is being tested?
- heparin and aspirin and clopidogrel
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2003to Jul 2008
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients greater than 18 years old with documented grade I-III blunt cerebrovascular injuries.
Who cannot join
- Pregnancy
- Nasal polyps
- Previous gastrointestinal bleeding secondary to antiplatelet medications
- Contraindication to systemic anticoagulation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Denver Health Medical Center
Denver, Colorado, 80204
About this study
Official title: Anticoagulation in the Management of Grade I-III Blunt Cerebrovascular Injuries
Originally thought to be a rare occurrence, BCVI are now diagnosed in approximately 1% of blunt trauma patients. Initially BCVI were thought to have unavoidable devastating neurologic outcomes. But early reports suggested anticoagulation might decrease these events. If untreated, carotid artery injuries (CAI) have a stoke rate up to 50% depending on injury grade, with increasing stroke rates correlating with increasing grades of injury. Current studies report early treatment with antithrombotics - either heparin or anti-platelet agents - in patients with BCVI markedly reduces stroke rates and resultant neurologic morbidity. As reports of bleeding complications have altered heparin protocols in these patients, the use of antiplatelet agents is attractive. Although heparin has been has been proposed as the gold standard treatment due to its initial empiric use, no comparative studies of antithrombotic agents has been performed.
In sum, Grade I-III blunt carotid and vertebral arterial injuries (BCVI) have the potential for stroke, and should be treated. Heparin has not been shown to clearly improve healing rates compared with antiplatelet therapy. The purpose of this study is to determine whether systemic anticoagulation alters the course of Grade I-III BCVI compared with antiplatelet therapy. The investigators study hypothesis is that Grade I-III BCVI will heal or progress to pseudoaneurysm formation, independent of systemic antithrombotic regimen, and that the combination of aspirin and clopidogrel is equally efficacious in preventing neurologic symptoms compared to systemic heparin associated with Grade I-III BCVI.
- Conditions
- Carotid Artery Injury, Vertebral Artery Injury
- Being tested
- heparin, aspirin and clopidogrel
- Medical subject headings
- Carotid Artery Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
heparinDrug
aspirin and clopidogrelDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurologic sequelae
Measured: during hospital visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2007 (estimated)
- Study startJul 2003
- Primary completionJul 2008 (estimated)
- Study completionJul 2008 (estimated)
Why it stopped: Study halted prematurely prior to enrollment of first participant.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Artery InjuryStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- C. Clay Cothren, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, C. Clay Cothren, MD, Denver Health and Hospital Authority
- Investigators
- Clay Cothren, MD, Principal investigator, Denver Health Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00494156
- Sponsor's protocol ID
- COMIRB 00-508
- Status last verified
- Oct 2015
- First submitted
- 25 Jun 2007
- Last updated
- 21 Oct 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anticoagulation in the Management of Grade I-III Blunt Cerebrovascular Injuries
- ClinicalTrials.gov ID
- NCT00494156
- Acronym / sponsor ID
- COMIRB 00-508
- Conditions
- Carotid Artery Injury, Vertebral Artery Injury
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study halted prematurely prior to enrollment of first participant.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- C. Clay Cothren, MDUniversity, hospital or other
- Study start
- Jul 2003
- Primary completion
- Jul 2008 (estimated)
- Study completion
- Jul 2008 (estimated)
- First posted
- 29 Jun 2007 (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.
Originally thought to be a rare occurrence, BCVI are now diagnosed in approximately 1% of blunt trauma patients. Initially BCVI were thought to have unavoidable devastating neurologic outcomes. But early reports suggested anticoagulation might decrease these events. If untreated, carotid artery injuries (CAI) have a stoke rate up to 50% depending on injury grade, with increasing stroke rates correlating with increasing grades of injury. Current studies report early treatment with antithrombotics - either heparin or anti-platelet agents - in patients with BCVI markedly reduces stroke rates and resultant neurologic morbidity. As reports of bleeding complications have altered heparin protocols in these patients, the use of antiplatelet agents is attractive. Although heparin has been has been proposed as the gold standard treatment due to its initial empiric use, no comparative studies of antithrombotic agents has been performed.
In sum, Grade I-III blunt carotid and vertebral arterial injuries (BCVI) have the potential for stroke, and should be treated. Heparin has not been shown to clearly improve healing rates compared with antiplatelet therapy. The purpose of this study is to determine whether systemic anticoagulation alters the course of Grade I-III BCVI compared with antiplatelet therapy. The investigators study hypothesis is that Grade I-III BCVI will heal or progress to pseudoaneurysm formation, independent of systemic antithrombotic regimen, and that the combination of aspirin and clopidogrel is equally efficacious in preventing neurologic symptoms compared to systemic heparin associated with Grade I-III BCVI.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients greater than 18 years old with documented grade I-III blunt cerebrovascular injuries.
Key exclusion criteria (4 listed)
- Pregnancy
- Nasal polyps
- Previous gastrointestinal bleeding secondary to antiplatelet medications
- Contraindication to systemic anticoagulation.
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 |
|---|---|---|
| heparin | Drug | – |
| aspirin and clopidogrel | Drug | – |
Primary outcome
Neurologic sequelae
Time frame: during hospital visit
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2015.
Related trials for Carotid Artery Injury
Not yet recruitingObservational study
Doppler Ultrasonography Parameters and Mortality in Traumatic Brain Injury
Traumatic Brain Injuries, Brain Injuries,Traumatic
Not yet recruitingPhase 2
A Ph2, Colchicine For Inflammatory Carotid Injury And Disease Evolution After Radiotherapy
Head and Neck Cancer
Active, not recruitingObservational study
Florida Cerebrovascular Disease Biorepository and Genomics Center
Cerebrovascular Disease, Ischemic Stroke
RecruitingObservational study
PANTHER Study of Terumo Aortic Knitted and Woven Grafts, and Cardiovascular Patches
Aneurysm, Dissection
RecruitingObservational study
Neurosurgical Outcome Network
Aneurysms, Arteriovenous Malformations
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.
Clay Cothren, MD principal investigator
Denver Health Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing heparin and aspirin and clopidogrel in people with Carotid Artery Injury and Vertebral Artery Injury, run by C. Clay Cothren, MD 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 1 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: withdrawn, as of the sponsor's last update on 21 Oct 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 withdrawn before enrolling participants, so there are no results.
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?
Neurologic sequelae (time frame: during hospital visit). 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 21 Oct 2015.