Standard vs Ultrasound-assisted Catheter Thrombolysis for Submassive Pulmonary Embolism
| Status: | Recruiting |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/31/2018 |
| Start Date: | October 19, 2017 |
| End Date: | January 31, 2020 |
| Contact: | Wissam Jaber, MD |
| Email: | wissam.jaber@emory.edu |
| Phone: | 404-686-1474 |
USAT-CDT Trial: Standard vs Ultrasound-assisted Catheter Thrombolysis for Submassive Pulmonary Embolism
The study is an investigator-initiated trial comparing two different catheters (standard
versus ultrasound assisted) for the treatment of acute high risk pulmonary embolism (blood
clots in lung arteries with evidence or heart strain). Patients already planned for the
procedure will be randomized to standard catheter-directed thrombolysis (CDT) or to
ultrasound-assisted catheter thrombolysis (USAT). Both catheters are currently used routinely
in practice for the treatment of pulmonary embolism, but it is not known if USAT is superior
to standard CDT, the former being much more expensive and more commonly used.
The purpose of the study is to learn about which catheter-directed therapy is more suitable
for patients with pulmonary embolism (PE), who are candidates for both standard catheter
directed therapy (CDT), and ultrasound-assisted catheter directed therapy (USAT), and to
provide information regarding the cost effectiveness of the two different types of treatment.
A total of 80 patients are planned to be recruited. All medication administration, procedures
or in-hospital tests will be performed as routine clinical practice. The study will compare
short term and long term outcomes: resolution of blood clots on CT scan, right ventricular
size improvement, quality of life and symptoms at 3 and 12 months, and cost effectiveness.
versus ultrasound assisted) for the treatment of acute high risk pulmonary embolism (blood
clots in lung arteries with evidence or heart strain). Patients already planned for the
procedure will be randomized to standard catheter-directed thrombolysis (CDT) or to
ultrasound-assisted catheter thrombolysis (USAT). Both catheters are currently used routinely
in practice for the treatment of pulmonary embolism, but it is not known if USAT is superior
to standard CDT, the former being much more expensive and more commonly used.
The purpose of the study is to learn about which catheter-directed therapy is more suitable
for patients with pulmonary embolism (PE), who are candidates for both standard catheter
directed therapy (CDT), and ultrasound-assisted catheter directed therapy (USAT), and to
provide information regarding the cost effectiveness of the two different types of treatment.
A total of 80 patients are planned to be recruited. All medication administration, procedures
or in-hospital tests will be performed as routine clinical practice. The study will compare
short term and long term outcomes: resolution of blood clots on CT scan, right ventricular
size improvement, quality of life and symptoms at 3 and 12 months, and cost effectiveness.
Acute pulmonary embolism (PE) accounts for 5-10% of in-hospital deaths. Systemic
anticoagulation (AC) is the standard of care and thrombolysis is recommended for those at a
higher mortality risk. Catheter-directed therapies, mainly standard catheter-directed
thrombolysis (CDT) and ultrasound-accelerated thrombolysis (USAT), have been introduced as
new, more effective, and safer treatment modalities. USAT is a modification of standard
catheter thrombolysis, utilizing a system of local ultrasound to dissociate the fibrin matrix
of the thrombus, allowing deeper penetration of lytics. However, there is limited data
comparing the two treatments. More rapid clearance of pulmonary thrombus by USAT compared to
standard CDT may prove to be more effective regarding clinical outcomes and cost (e.g. via
reduced length of ICU and hospital stay). Alternatively, if thrombus clearance is similar,
the cost of USAT may exceed the cost of CDT (equipment and disposables), without offering any
potential advantage.
This controlled, randomized study seeks to determine if ultrasound acceleration adds any
benefits in the outcomes and costs of catheter-directed thrombolysis for patients with acute
submassive PE. The treatment with CDT or USAT are standard of care for submassive PE and
participants will be randomized to receive one treatment or the other. Participants will have
follow up visits at 3 months and 12 months post procedure. All the procedures, tests, and
follow up visits are according to current standard of care.
anticoagulation (AC) is the standard of care and thrombolysis is recommended for those at a
higher mortality risk. Catheter-directed therapies, mainly standard catheter-directed
thrombolysis (CDT) and ultrasound-accelerated thrombolysis (USAT), have been introduced as
new, more effective, and safer treatment modalities. USAT is a modification of standard
catheter thrombolysis, utilizing a system of local ultrasound to dissociate the fibrin matrix
of the thrombus, allowing deeper penetration of lytics. However, there is limited data
comparing the two treatments. More rapid clearance of pulmonary thrombus by USAT compared to
standard CDT may prove to be more effective regarding clinical outcomes and cost (e.g. via
reduced length of ICU and hospital stay). Alternatively, if thrombus clearance is similar,
the cost of USAT may exceed the cost of CDT (equipment and disposables), without offering any
potential advantage.
This controlled, randomized study seeks to determine if ultrasound acceleration adds any
benefits in the outcomes and costs of catheter-directed thrombolysis for patients with acute
submassive PE. The treatment with CDT or USAT are standard of care for submassive PE and
participants will be randomized to receive one treatment or the other. Participants will have
follow up visits at 3 months and 12 months post procedure. All the procedures, tests, and
follow up visits are according to current standard of care.
Inclusion Criteria:
- Patients eligible for catheter directed thrombolysis per the study protocol for
submassive pulmonary embolism (PE)
- CT or echocardiographic RV strain (defined as RV/LV ratio >1)
- without persisting hypotension <90mmHg or drop of systolic blood pressure by at
least 40mm Hg for at least 15 minutes with signs of end-organ hypoperfusion (cold
extremities or low urinary output <30 mL/h or mental confusion)
- without the need of catecholamine support
- without the need of cardiopulmonary resuscitation
Exclusion Criteria:
- Pregnancy
- Index PE symptom duration >14 days
- High bleeding risk (any prior intracranial hemorrhage, known structural intracranial
cerebrovascular disease or neoplasm, ischemic stroke within 3 months, suspected aortic
dissection, active bleeding or bleeding diathesis, recent spinal or cranial/brain
surgery, recent closed-head or facial trauma with bony fracture or brain injury)
- Participation in any other investigational drug or device study
- Life expectancy <90 days
- Inability to comply with study assessments
We found this trial at
4
sites
550 Peachtree St NE
Atlanta, Georgia 30308
Atlanta, Georgia 30308
(404) 686-4411
Phone: 404-686-1474
Emory University Hospital Midtown Emory University Hospital Midtown is a 511-bed community-based, acute care teaching...
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1364 Clifton Rd NE
Atlanta, Georgia 30322
Atlanta, Georgia 30322
(404) 712-2000
Phone: 404-686-1474
Emory University Hospital As the largest health care system in Georgia and the only health...
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