Pulmonary embolism Home treatment Low-molecular-weight-heparin And in Dutch: Longembolie Thuisbehandeling Laag-moleculair-gewicht-heparine
Conditions
Interventions
Patients with objectively proven PE will be triaged for possibility of treatment with LMWH out of the hospital.
Initial anticoagulant treatment with LMWH can be started on the basis of the clinical
Sponsors
Leiden University Medical Center,
Department of General Internal Medicine-Endocrinology
Eligibility
Inclusion criteria
Inclusion criteria: 1. Consecutive patients with proven acute non-massive, stable Pulmonary Embolism (PE), i.e. PE that does not warrant thrombolytic therapy, presenting to the emergency ward or to the outpatient clinic. 2. Patients with provoked and non-provoked (‘idiopathic’) pulmonary embolism and patient with a first as well as those with a recurrent episode of pulmonary embolism are considered eligible for the study.
Exclusion criteria
Exclusion criteria: 1. Patients who have had symptoms of PE for longer than 7 days duration 2. 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, or thrombocytopenia (platelet count < 75 x 109/L) 3. PE accompanied by hemodynamic instability. The criteria for instability are left to the discretion of the investigator. 4. Massive PE requiring thrombolytic treatment or pulmonary embolectomy 5. Requirement for oxygen therapy to maintain oxygen saturation greater than 90% 6. Severe pain requiring intravenous narcotic analgesia 7. 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 8. Severe renal failure e.g. calculated creatinine clearance < 30 ml/min. 9. Severe liver failure 10. Diagnosis of PE during anticoagulant treatment 11. Previously documented heparin induced thrombocytopenia 12. Pregnancy 13. Age less than 18 years 14. Likelihood of non-compliance (e.g. no fixed address) 15. Life expectancy less than three months 16. Failure to sign informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy and safety of home treatment 1. Recurrent thromboembolic events are defined as recurrent pulmonary embolism if demonstrated by new defects on helical CT scan, perfusion-ventilation lung scan or pulmonary angiography or PE at autopsy or a clinical report indicating PE as the (likely) cause of death; or deep vein thrombosis demonstrated by compression ultrasonography or contrast venography. 2. Bleeding is defined as major if it is clinically overt e.g. a clinically apparent bleeding or sign and symptoms suggestive of bleeding confirmed with imaging studies (ultrasound, computer tomography (CT)) combined with at least one of the following situations: a) Critical site involvement e.g. intracranial, retroperitoneal, intraocular, intraspinal, pericardial or non-traumatic intra-articular. b) Bleeding associated with a decrease in hemoglobin level of 1.3 mmol/L (2.0 gr/dl) or more. c) Bleeding leading to transfusion of > 2 units of whole blood or packed red cells. d) Fatal bleeding. 3. The cause of death in patients who die within the study period is assessed by autopsy or a clinical report indicating the – likely - cause of death. | — |
Secondary
| Measure | Time frame |
|---|---|
| A health economics evaluation in all patients | — |
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