Efficacy and safety of home treatment versus in hospital treatment with LMWH in patients with non-massive pulmonary embolism

Efficacy and safety of home treatment versus in hospital treatment with LMWH in patients with non-massive pulmonary embolism - The Hestia Study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON32323

Enrollment

280

Registered

2008-03-14

Start date

2009-02-18

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary embolism Venous-thromboembolism

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Consecutive patients with proven acute non-massive, stable PE 2. Age over 18 3. Informed consent

Exclusion criteria

Exclusion criteria: 1. Patients who have had symptoms of PE for longer than 7 days duration 2. Diagnosis of PE during anticoagulant treatment 3. Active bleeding, or a very high risk for major bleeding 4. Severe pain requiring intravenous narcotic analgesia 5. Medical or social condition which necessitates admission to the hospital for another reason 6. Pregnancy 7. Severe renal of liver failure 8. Previously documented heparin induced thrombocytopenia

Design outcomes

Primary

Measure	Time frame
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 of six months is assessed by autopsy or a clinical report indicating the - likely - cause of death.	—

Measure

Time frame

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 of six months is assessed by autopsy or a clinical report indicating the - likely - cause of death.

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Secondary

Measure	Time frame
- a health economics evaluation in all patients - a quality of life evaluation in all patients	—

Countries

Netherlands

Outcome results