Ignite Creation Date:
2024-05-05 @ 6:30 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00494156
Status:
WITHDRAWN
Last Update Posted:
2015-10-21
First Post:
2007-06-25
Brief Title:
Anticoagulation in Blunt Cerebrovascular Injuries
Sponsor:
C Clay Cothren MD
Organization:
Denver Health and Hospital Authority
Study Overview
Official Title:
Anticoagulation in the Management of Grade I-III Blunt Cerebrovascular Injuries
Status:
WITHDRAWN
Status Verified Date:
2015-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study halted prematurely prior to enrollment of first participant
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None