Reperfusion Treatment in Acute Pulmonary Embolism
ConditionPulmonary Embolism
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSahlgrenska University Hospital
About this trial
International guidelines recommend immediate reperfusion with systemic thrombolysis (ST) as first-line treatment in high-risk pulmonary embolism (PE). The therapy improves hemodynamics and overall survival but is also associated with a significant risk of severe bleeding. Catheter-directed intervention (CDI) is recommended as an alternative reperfusion therapy in high-risk PE when ST is contraindicated or has failed, as well as in patients who deteriorate or fail to improve during anticoagulation (AC) treatment. Despite lack of high-quality evidence and randomized studies between CDI and standard care, the use of CDI is spreading rapidly in high-risk PE and in less severe PE not fulfilling current treatment criteria.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All adult patients (≥18 years), including pregnant women, with verified (CTPA, angiography or scintigraphy) acute pulmonary embolism who are planned for, or have received, treatment with catheter directed intervention or systemic thrombolysis
Informed consent (for patients who do not survive before informed consent can be obtained, a waiver of consent applies)
Disqualifiers
Ongoing enrolment in interventional catheter directed intervention trial
Surgical embolectomy as primary reperfusion treatment
Trial population
Pulmonary embolism patients treated with catheter directed intervention or systemtic thrombolysis in hospitals in Sweden and Denmark where the former treatment modality is established.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Catheter directed intervention, any device
Procedure/SurgeryCatheter directed intervention for treatment of pulmonary embolism
Alteplase
DrugSystemic thrombolysis
Treatment groups
220 Participants
are divided into 2 treatment groupsGroup A: Catheter-directed intervention1 intervention
Group B: Systemic thrombolysis1 intervention
Trial outcomes
Primary outcomes
1
Composite of severe bleeding or mortality at 30 days
A composite of severe bleeding according to GUSTO (defined as intracranial bleeding or bleeding with substantial hemodynamic com-promise requiring treatment) or death within 30 days after treatment
Time frame
From treatment to day 30 after treatmentSecondary outcomes
1
Mortality
Incidence of all-cause mortality
Time frame
30 days2
Mortality
Cause of death
Time frame
30 days3
Bleeding
Defined by GUSTO criteria, severe/non-severe.
Time frame
30 days4
Rescue treatment
Incidence of rescue treatment for PE (Systemic thrombolysis/Catheter-directed intervention/extracorporeal membrane oxygenation (ECMO)/surgical embolectomy)
Time frame
30 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Sahlgrenska University Hospital
Lead sponsor
Stockholm South General Hospital
Collaborator
Karolinska University Hospital
Collaborator
Danderyd Hospital
Collaborator
University Hospital, Linkoeping
Collaborator
Sunderby Hospital
Collaborator
Aarhus University Hospital
Collaborator
Örebro University, Sweden
Collaborator
Odense University Hospital
Collaborator
Skane University Hospital
Collaborator
Rigshospitalet, Denmark
Collaborator
Source ClinicalTrials.gov