Pulmonary embolism Outpatient treatment In dutch: longembolie thuisbehandeling
Conditions
Interventions
Patients with acute PE not applying to one of the criteria of the Hestia rule are randomized in two treatment strategy groups:
1. Outpatient treatment
2. Outpatient treatment depending on NT-proBNP levels.
Sponsors
Leiden University Medical Centre,
Leiden, The Netherlands
Eligibility
Inclusion criteria
Inclusion criteria: Consecutive patients with proven acute, hemodynamically stable PE, i.e. PE that does not warrant thrombolytic therapy, presenting to the emergency department or to the outpatient clinic. Patients with provoked and unprovoked PE are eligible.
Exclusion criteria
Exclusion criteria: 1. Age less than 18 years; 2. Acute onset or acute worsening of symptoms indicative of PE lasting for more than 14 days; 3. Active bleeding, or a very high risk for major bleeding, i.e. gastro-intestinal bleeding in the preceding 14 days, recent stroke (less than 4 weeks ago), recent operation (less than 2 weeks ago, when in doubt bleeding risk can be assessed in consultation with the surgeon), bleeding disorder, thrombocytopenia (platelet count 180 mm Hg or diastolic blood pressure > 110 mm Hg); 4. PE accompanied by hemodynamic instability. The criteria for instability include the following: systolic blood pressure 100 beats per minute; possibly in combination with one or more of the following symptoms of organ perfusion defects: oliguria, pale skin or elevated lactate levels in arterial blood gas analysis, altered mental state, or any other PE related condition requiring admission to an intensive care unit; 5. Acute PE requiring thrombolytic treatment or pulmonary embolectomy; 6. Requirement for oxygen therapy to maintain oxygen saturation greater than 90%; 7. Severe pain requiring intravenous narcotic analgesia; 8. Medical or social condition which necessitates admission to the hospital for another reason (for example infection, cancer or stroke) without discharge in the next 24hours; 9. Diagnosis of PE during anticoagulant treatment (prophylactic doses of LMWH are allowed); 10. Severe renal failure e.g. calculated creatinine clearance < 30 ml/min. Cockcroft-Gault formula or MDRD is acceptable; 11. Pregnancy; 12. Previously documented heparin induced thrombocytopenia; 13. Severe liver failure (according judgement of physician); 14. Likelihood of non-compliance (e.g. no fixed address); 15. Life expectancy less than three months; 16. Participation in this study during a previous episode of acute PE; 17. Participation in another therapeutic trial (diagnostic studies are allowed); 18. Failure to sign informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 30 day adverse outcome defined as occurrence of any of the following: 1. PE or major bleeding related mortality; 2. Cardiopulmonary resuscitation; 3. Mechanical ventilation; 4. Use of vasopressors; 5. Thrombolytic therapy given; 6. Thrombosuction; 7. Open surgical embolectomy; 8. PE or major bleeding related admission to IC unit. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Recurrent venous thromboembolism; 2. Major bleeding and all-cause mortality during three months; 3. Also ten day mortality due to PE or its treatment and ten day adverse outcome defined as occurrence of any of the following: PE or major bleeding related mortality, cardiopulmonary resuscitation, mechanical ventilation, use of vasopressors, thrombolytic therapy given, thrombosuction, open surgical embolectomy or PE or major bleeding related admission to IC unit are considered as secondary endpoints. | — |
Contacts
Public ContactM.V. Huisman
Leiden University Medical Center (LUMC) Department of Thrombosis and Haemostasis Room C4-68 P.O Box 9600
Outcome results
None listed