Status:
COMPLETED
Breath Analysis Technique to Diagnose Pulmonary Embolism
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
WFD Ventures Incorporated
Conditions:
Pulmonary Embolism
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
A pulmonary embolism (PE) is a blockage in one of the arteries of the lungs, and is usually caused by a traveling blood clot. The D-dimer blood test is currently used to diagnose PEs, but it is not al...
Detailed Description
PE is the second leading cause of sudden, unexpected death in the United States. In 90% of the cases, it is caused by deep vein thrombosis: a blood clot forms in a vein, travels through the bloodstrea...
Eligibility Criteria
Inclusion
- Phase I
- Experienced or is scheduled for at least one of the following:
- Hip or knee replacement surgery
- Hip or acetabular fracture surgery
- Pelvic fracture
- Decompression for spinal stenosis surgery
- Scoliosis corrective surgery
- Craniotomy surgery for brain tumor
- Surgery for any of the following cancers: bladder, colon (including caecum and rectum), kidney, ovary, pancreas, or uterus
- Phase I
Exclusion
- Currently undergoing treatment for PE or has received treatment for PE in the 4 weeks prior to study entry
- Hospitalized for fewer than 2 days
- Anatomic abnormality that would prevent use of a mouthpiece
- Living situation that makes follow-up difficult (e.g., homeless, incarcerated)
- Phase II Inclusion Criteria:
- Clinical suspicion of PE with signs or symptom suggestive of PE within 24 hours of presentation and at least one risk factor for PE, as defined under the criteria as outlined in this protocol
- CTA of pulmonary arteries ordered by clinical care providers
- 18 years or older or an emancipated 17 year old
- Written informed consent
- Phase II
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
475 Patients enrolled
Trial Details
Trial ID
NCT00368836
Start Date
January 1 2006
End Date
June 1 2008
Last Update
April 21 2022
Active Locations (1)
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1
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203