Safety and efficiency of home treatment based on Hestia rule versus Hestia rule and NT-proBNP in patients with acute pulmonary embolism

Phase 4

Recruiting

• Conditions: pulmonary embolism; venous thromboembolism; 10014523

• Registration Number: NL-OMON38133
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 530

Inclusion Criteria

- objectively proven pulmonary embolism
- age 18 years or older
- presenting to outpatient clinic or emergency ward

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 < 75 x 109/L) or uncontrolled hypertension (systolic blood pressure > 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 mmHg with heart rate > 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 < 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>30 day adverse outcome defined as occurrence of any of the following: PE or<br /><br>major bleeding related mortality, cardiopulmonary resuscitation, mechanical<br /><br>ventilation, use of vasopressors, thrombolytic therapy given, thrombosuction,<br /><br>open surgical embolectomy or PE or major bleeding related admission to IC unit.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- 3 month major bleedings<br />- 3 month recurrent pulmonary embolism<br />- 3 month all-cause mortality</p>