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WithdrawnNCT00494156Updated Oct 21, 2015

Anticoagulation in Blunt Cerebrovascular Injuries

An interventional study of heparin and aspirin and clopidogrel in Carotid Artery Injury and Vertebral Artery Injury, sponsored by C. Clay Cothren, MD. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-10-21.

Sponsored by C. Clay Cothren, MD · Not applicable, Interventional, and Prevention

Why this study was withdrawn
Study halted prematurely prior to enrollment of first participant.
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Carotid Artery Injury
  • Vertebral Artery Injury

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03

In context

Wounds and Injuries

5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.

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Lead sponsor

This is the only study on the registry with C. Clay Cothren, MD as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients greater than 18 years old with documented grade I-III blunt cerebrovascular injuries.

Exclusion criteria

Exclusion Criteria:

  • Pregnancy
  • Nasal polyps
  • Previous gastrointestinal bleeding secondary to antiplatelet medications
  • Contraindication to systemic anticoagulation.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Interventions

  • Drugheparin
  • Drugaspirin and clopidogrel
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What researchers measure

Primary outcomes

  1. Neurologic sequelae

    Time frame: during hospital visit

07

Study locations

1 site
  • Denver Health Medical Center
    Denver, Colorado 80204, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 21, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00494156
Lead sponsor
C. Clay Cothren, MD
Responsible party
C. Clay Cothren, MD (Principal Investigator, Denver Health and Hospital Authority) — Sponsor-investigator
First posted
Jun 29, 2007
Start date
Jul 2003
Primary completion
Jul 2008 (estimated)
Completion
Jul 2008 (estimated)
Last update
Oct 21, 2015

Study contacts

Clay Cothren, MD
principal investigator · Denver Health Medical Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

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