Survival and quality of life of cancer patients diagnosed with previously unsuspected pulmonary embolism

Phase 1

• Conditions: Incidental Pulmonary Embolism in Cancer Patients; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-001707-31-GB
• Lead Sponsor: Hull & East Yorkshire Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-05-14
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 390

Inclusion Criteria

A. i-PE group:
1) Adults =18 years.
2) Active cancer.
3) Incidentally diagnosed with pulmonary embolism.
4) Able to provide written informed consent.
5) Able to complete study assessments
6) LMWH considered as standard care

B. prospective recruited control group
1) Adults =18 years.
2) Active cancer.
3) Able to provide written informed consent.
4) Able to complete study assessments.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1) No Cancer.
2) No PE.
3) Other thrombosis without concurrent PE (deep vein thrombosis (DVT), splanchnic VTE)
4)Anticoagulation contraindications.
a) Brain metastasis.
b) Platelets = 50x 10 log 9/l
c) Known bleeding tumour with active bleeding, eg:
- Bladder tumour with haematuria
- Lung tumour with haemoptysis
- Gastric tumour with hematemesis
5) Allergy reaction/ previous side effects of heparin (heparin-induced thrombocytopenia [HIT])
6) Patients already on warfarin or already anticoagulated with LMWH
7) Recent brain surgery within 6 months.
8) Vascular surgery within 6 months
9) Other arterial event (without concurrent PE)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified