Reperfusion Treatment in Acute Pulmonary 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

Qualifiers

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 design

Treatments tested in this trial

  • Catheter directed intervention, any device
  • Alteplase

Treatment groups

220 Participants
are divided into 2 treatment groups

Sponsors and collaborators

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