|- candidate number||3312|
|- NTR Number||NTR1319|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||22-mei-2008|
|- Secondary IDs||P07-244 METC LUMC|
|- Public Title||Efficacy and safety of home treatment versus in hospital treatment with LMWH in patients with non-massive pulmonary embolism|
|- Scientific Title||Efficacy and safety of home treatment versus in hospital treatment with LMWH in patients with non-massive pulmonary embolism|
|- ACRONYM||Hestia study|
|- hypothesis||Outpatient LMHW treatment in patients with objectively proven non-massive pulmonary embolism is efficacious and safe.|
|- Healt Condition(s) or Problem(s) studied||Pulmonary embolism, Home treatment, Low-molecular-weight-heparin|
|- 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||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
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.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||6-mei-2008|
|- planned closingdate||6-nov-2008|
|- Target number of participants||260|
|- 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 symptoms of the patient and consists of subcutaneous injections once daily for a minimum of five days. All patients who can be treated at home are sent home either immediately or within 24 hours after PE is objectively diagnosed.
|- Primary outcome||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 outcome||A health economics evaluation in all patients
|- Timepoints||One week, six weeks and three months after diagnosis.|
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||MD. PhD. M.V. Huisman|
|- CONTACT for SCIENTIFIC QUERIES||MD. PhD. M.V. Huisman|
|- Sponsor/Initiator ||Leiden University Medical Center (LUMC), Department of General Internal Medicine-Endocrinology|
(Source(s) of Monetary or Material Support)
|GlaxoSmithKline, Leiden University Medical Center (LUMC)|
|- Brief summary||While evidence is accumulating that initial home treatment of patients with acute PE may be feasible and safe, no study has conclusively demonstrated effective and safe out of hospital treatment in patients with acute PE. Given this limited evidence, clinicians remain reluctant to routinely treat patients with non-massive pulmonary embolism at home with LMWH and as a result, nearly all patients presenting with acute PE still receive initial treatment at the hospital. |
The purpose of the current study is to evaluate the efficacy and safety of out of hospital LMWH treatment in consecutive patients with acute non-massive PE. In addition, a health economics evaluation will be performed.
|- Main changes (audit trail)|
|- RECORD||22-mei-2008 - 3-jul-2010|