ow dose catheter directed thrombolytic therapy for patients suffering from acute pulmonary embolism.

Phase 1

• Conditions: Acute intermediary-high risk pulmonary embolism; MedDRA version: 21.0Level: PTClassification code 10037377Term: Pulmonary embolismSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2018-003564-31-DK
• Lead Sponsor: Aarhus University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-27
• Last Update Posted: 22 November 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

- Age > 17 and < 81 years
- Debut of symptoms <14 days
- Acute symptomatic Intermediate-high risk PE (according to 2014 ESC guidelines) confirmed by CTA with the embolus located in at least one proximal lower lobe or main pulmonary artery.
- Right-to-left ventricular dimension ratio >1.0 on contrast enhanced computed tomography or transthoracic echocardiography.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

- Significant bleeding risk or other contraindications to catheter directed trombolysis or unfractioned heparin.*
- Not possible to perform catheter directed trombolysis within 48 h after diagnosis
- Known pregnancy or positive urine hCG screening test in fertile women**
- Cardiac arrest requiring cardiopulmonary resuscitation
- Life expectancy < 120 days
- Altered mental status such that the patient is unable to provide informed consent
- Chronic thromboembolic pulmonary hypertension
- Sustained hypertension (>180 mmHg systolic and/or >105 mmHg diastolic)

*Treated with thrombolytics for the index
** Fertile women will be screened for pregnancy with a blood hCG screening test before inclusion if they are not on any contraceptives.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified