Thrombolytic TherapySPEEKNCT02926742
Submassive Pulmonary Embolism Experience With EKOS
An observational study of Thrombolytic Therapy and Thrombolysis, run by Krishna Mannava, MD, FACS, RPVI at 1 site in United States.
Trial summary
This single site study evaluates the efficacy of ultrasound accelerated thrombolysis using EKOS Endovascular Device with a standard infusion of thrombolytics for treatment of PE Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombolytic Therapy, Thrombolysis, Mechanical Thrombolysis
- What is being tested?
- EkoSonic Endovascular System
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Feb 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospital setting. Volunteers meeting the inclusion/ exclusion criteria who are patients of Fairfield Medical Center located in Lancaster, Oho
Who may be able to join
- Acute symptomatic PE confirmed by CT, with filling defect in at least one main or segmental pulmonary artery.
- RV dysfunction as evidenced by RV/LV ratio > 0.9 on echo
- Ability to give informed consent or Legally Authorized Representative (LAR) is able to give consent
- PE symptom duration < 21 days
- Age >18 years
- And, a MBS baseline measurement above 3 plus at least one of the following: O2 sat < 90% RA, or inability to maintain a HR <100, or inability to maintain a Systolic Bp > 100. Whichever measurement is chosen for inclusion criteria in addition to the MBS will also be used in determination of therapeutic endpoint (i.e. O2 Sat., HR<100 or BP >100)..
Who cannot join
- Stroke or transient ischemic attack (TIA), head trauma, or other active intracranial or intraspinal disease within one year
- Recent (within one month) or active bleeding from a major organ
- Hemoglobin (Hgb) < 8.0
- Platelets < 60 thousand/µL
- Major surgery within seven days
- Clinician deems high-risk for catastrophic bleeding
Show all 14Show fewer
- History of heparin-induced thrombocytopenia (HIT)
- Pregnancy
- Catheter-based pharmacomechanical treatment for pulmonary embolism within 3 days of study enrollment
- Systolic blood pressure less than 80 mm Hg despite vasopressor or inotropic support
- Cardiac arrest (including pulseless electrical activity and asystole) requiring active cardiopulmonary resuscitation (CPR)
- Evidence of irreversible neurological compromise
- Life expectancy < 30 days
- Use of thrombolytics or glycoprotein IIb/IIIa antagonists within 3 days prior to inclusion in the study
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Fairfield Medical Center
Lancaster, Ohio, 43130
Lisa K Stevens, MSN, 740-689-4426, lisas@fmchealth.org
Krishna Mannava, MD, 7406876910, kmannava@fmchealth.org
About this study
This single site study evaluates the efficacy of ultrasound accelerated thrombolysis using EKOS Endovascular Device with a standard infusion of thrombolytics for treatment of PE
Read the detailed description
Previous clinical trials examining thrombolytics used to treat Acute Submassive PE, many times will use fixed dose and duration. Little research has been conducted on the physiologic implication of resolution of symptoms. It seems reasonable, that symptomatic relief results from some degree of hemodynamic normalization. This study will seek to examine the extent to which the hemodynamic impairment is normalized from a thrombolytic treatment protocol with an endpoint of therapy determined as resolution of presenting symptoms. Treatment plans will utilize the MBS (Modified Borg Scale) score to help evaluate and measure outcome-based care, quantifying shortness of breath.
- Being tested
- EkoSonic Endovascular System
- Keywords
- Thrombolysis, Ultrasound Thrombolysis, Pulmonary Embolism, Saddle PE, Submassive PE, Massive PE, Bilateral PE
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EkoSonic Endovascular SystemDevice
Ultrasound catheter-directed thrombolysis.
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of RV dysfunction
Reduction of RV dysfunction as evidenced by a reduction in RVSP and or a reduction in RV/LV ratio measured by echo at baseline and again at 48 ±6 hours post EKOS catheter removal
Measured: 48 hours post catheter removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2016 (estimated)
- Study startFeb 2014
- Primary completionFeb 2017 (estimated)
- Study completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thrombolytic TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Krishna Mannava, MD, FACS, RPVI
- Sponsor type
- University, hospital or other
- Collaborators
- EKOS Corporation
- Responsible party
- Sponsor-investigator, Krishna Mannava, MD, FACS, RPVI, Fairfield Medical Center
- Investigators
- Lisa K Stevens, MSN, Study director, Fairfield Medical CenterKrishna Mannava, MD, Principal investigator, Fairfield Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02926742
- Sponsor's protocol ID
- FMCspeekEKOSstudy
- Acronym
- SPEEK
- Status last verified
- Oct 2016
- First submitted
- 5 Oct 2016
- Last updated
- 6 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: De-identified individual study participant data will be made available 6 months after study completion. This data to include all primary and secondary outcome measures.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Submassive Pulmonary Embolism Experience With EKOS
- ClinicalTrials.gov ID
- NCT02926742
- Acronym / sponsor ID
- SPEEK / FMCspeekEKOSstudy
- Keywords
- Thrombolysis, Ultrasound Thrombolysis, Pulmonary Embolism, Saddle PE, Submassive PE, Massive PE, Bilateral PE
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Krishna Mannava, MD, FACS, RPVIUniversity, hospital or other
- Collaborators
- EKOS Corporation
- Study start
- Feb 2014
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 6 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This single site study evaluates the efficacy of ultrasound accelerated thrombolysis using EKOS Endovascular Device with a standard infusion of thrombolytics for treatment of PE
Detailed description
Previous clinical trials examining thrombolytics used to treat Acute Submassive PE, many times will use fixed dose and duration. Little research has been conducted on the physiologic implication of resolution of symptoms. It seems reasonable, that symptomatic relief results from some degree of hemodynamic normalization. This study will seek to examine the extent to which the hemodynamic impairment is normalized from a thrombolytic treatment protocol with an endpoint of therapy determined as resolution of presenting symptoms. Treatment plans will utilize the MBS (Modified Borg Scale) score to help evaluate and measure outcome-based care, quantifying shortness of breath.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospital setting. Volunteers meeting the inclusion/ exclusion criteria who are patients of Fairfield Medical Center located in Lancaster, Oho
Key inclusion criteria (6 listed)
- Acute symptomatic PE confirmed by CT, with filling defect in at least one main or segmental pulmonary artery.
- RV dysfunction as evidenced by RV/LV ratio > 0.9 on echo
- Ability to give informed consent or Legally Authorized Representative (LAR) is able to give consent
- PE symptom duration < 21 days
- Age >18 years
Key exclusion criteria (14 listed)
- Stroke or transient ischemic attack (TIA), head trauma, or other active intracranial or intraspinal disease within one year
- Recent (within one month) or active bleeding from a major organ
- Hemoglobin (Hgb) < 8.0
- Platelets < 60 thousand/µL
- Major surgery within seven days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EkoSonic Endovascular SystemUltrasound catheter-directed thrombolysis. | Device | – |
Primary outcome
Reduction of RV dysfunction
Time frame: 48 hours post catheter removal
Reduction of RV dysfunction as evidenced by a reduction in RVSP and or a reduction in RV/LV ratio measured by echo at baseline and again at 48 ±6 hours post EKOS catheter removal
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2016.
- Individual participant dataSharing planned: Undecided. De-identified individual study participant data will be made available 6 months after study completion. This data to include all primary and secondary outcome measures.
Related trials for Thrombolytic Therapy
RecruitingObservational study
Pulmonary Embolism Registry From Short-Term Emergency to Long-Term Follow-Up and Surveillance
Venous Thromboembolism (VTE), Chronic Thromboembolic Pulmonary Hypertension
Not yet recruiting
Percutaneous Mechanical Thrombectomy With or Without Low-Dose Catheter-Directed Thrombolysis in Acute Intermediate-High Risk Pulmonary Embolism
Acute Pulmonary Embolism
RecruitingPhase 4
Safety and Efficacy of Intravenous Thrombolysis in Patients With Ischemic Stroke and Direct Oral Anticoagulants Intake
Ischemic Stroke
Not yet recruiting
SAIL-MEVO: Endovascular Treatment Versus Best Medical Therapy for Distal Vessel Occlusions
Medium Vessel Occlusion Stroke (MeVO), Stroke Acute
Not yet recruiting
COOLing of the Ischemic PENumbra in Patients With Acute Ischemic Stroke.
Acute Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa K Stevens, MSN study director
Fairfield Medical Center
Krishna Mannava, MD principal investigator
Fairfield Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thrombolytic Therapy and Thrombolysis, run by Krishna Mannava, MD, FACS, RPVI at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lisa K Stevens, MSN (7406894426, lisas@fmchealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of RV dysfunction (time frame: 48 hours post catheter removal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2016.