Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00178789
Status:
COMPLETED
Last Update Posted:
2007-05-23
First Post:
2005-09-13
Brief Title:
Sonography Outcomes Assessment Program for Lower Extremity Deep Venous Thrombosis
Sponsor:
The University of Texas Health Science Center Houston
Organization:
The University of Texas Health Science Center Houston
Study Overview
Official Title:
Prospective Observational Trial of Point-of-Care Limited Ultrasonography PLUS for Lower Extremity Deep Venous Thrombosis in the Emergency Department The Sonography Outcomes Assessment Program SOAP-4 Trial
Status:
COMPLETED
Status Verified Date:
2007-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Currently most emergency physicians have limited access to obtaining formal radiology ultrasound studies particularly overnight Many are forced to adopt risky and expensive strategies in managing their patients with suspected deep venous thrombosis DVT who present during off-hours for low risk patients discharging without anticoagulation and arranging for outpatient studies for moderate to high risk patients empirically anticoagulating and admitting to the hospital to await definitive testing If emergency physicians could reliably perform an accurate ultrasound exam for DVT such risks could be obviated
This is a prospective observational cohort study assessing the accuracy of emergency physician diagnosis of proximal DVT using compact ultrasound equipment and a simplified compression technique The value of color flow doppler and augmentation will also be assessed Outcomes sensitivity specificity positive likelihood ratio and negative likelihood ratio will be assessed at 30 days
Prior to enrolling patients in the study emergency physicians will undertake a 2 hour training course on the performance of the simplified compression technique for the diagnosis of lower extremity DVT Emergency physicians will perform the DVT ultrasound exam on study subjects with suspected DVT Clinical management of the study subjects will not be altered all subjects will proceed to receive a formal DVT ultrasound study by the radiology department which will serve as the criterion reference for the study
This is a prospective observational cohort study assessing the accuracy of emergency physician diagnosis of proximal DVT using compact ultrasound equipment and a simplified compression technique The value of color flow doppler and augmentation will also be assessed Outcomes sensitivity specificity positive likelihood ratio and negative likelihood ratio will be assessed at 30 days
Prior to enrolling patients in the study emergency physicians will undertake a 2 hour training course on the performance of the simplified compression technique for the diagnosis of lower extremity DVT Emergency physicians will perform the DVT ultrasound exam on study subjects with suspected DVT Clinical management of the study subjects will not be altered all subjects will proceed to receive a formal DVT ultrasound study by the radiology department which will serve as the criterion reference for the study
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