pulmonary embolism venous thromboembolism
Conditions
Interventions
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - objectively proven pulmonary embolism - age 18 years or older - presenting to outpatient clinic or emergency ward
Exclusion criteria
Exclusion criteria: 1. Age less than 18 years 2. Acute onset or acute worsening of symptoms of PE (shortness of breath or chest pain without another obvious cause) 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), 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 (profylatic dosis of LMWH is allowed) 10. Severe renal failure e.g. calculated creatinine clearance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 30 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| - 3 month major bleedings - 3 month recurrent pulmonary embolism - 3 month all-cause mortality | — |
Countries
Netherlands
Outcome results
None listed