Reperfusion Treatment in Acute Pulmonary Embolism: A Multicenter Observational Study in the Nordic Countries

Status: Recruiting
Location: See all (13) locations...
Intervention Type: Drug, Procedure
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Denmark
Aarhus University Hospital
RECRUITING
Aarhus
Rigshospitalet
RECRUITING
Copenhagen
Odense University Hospital
RECRUITING
Odense
Sweden
Sahlgrenska University Hospital
RECRUITING
Gothenburg
Linköping University Hospital
RECRUITING
Linköping
Sunderby Hospital
RECRUITING
Luleå
Skåne University Hospital
RECRUITING
Lund
Örebro University Hospital
RECRUITING
Örebro
Danderyd Hospital
RECRUITING
Stockholm
Karolinska University Hospital Huddinge
RECRUITING
Stockholm
Karolinska University Hospital Solna
RECRUITING
Stockholm
Södersjukhuset
RECRUITING
Stockholm
Uppsala University Hospital
NOT_YET_RECRUITING
Uppsala
Contact Information
Primary
Freyr Einarsson, MD
freyr.einarsson@vgregion.se
+46500 43 10 36
Backup
Annika Odenstedt, coordinator
annika.odenstedt@vgregion.se
+46 343 53 94
Time Frame
Start Date: 2025-04-01
Estimated Completion Date: 2029-05-01
Participants
Target number of participants: 220
Treatments
Catheter-directed intervention
Catheter-directed intervention, any device
Systemic thrombolysis
Intravenous thrombolysis with tissue-type plasminogen activator (tPA)
Related Therapeutic Areas
Sponsors
Collaborators: Sunderby Hospital, Stockholm South General Hospital, Karolinska University Hospital, University Hospital, Linkoeping, Odense University Hospital, Danderyd Hospital, Örebro University, Sweden, Skane University Hospital, Rigshospitalet, Denmark, Aarhus University Hospital
Leads: Sahlgrenska University Hospital

This content was sourced from clinicaltrials.gov