- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07671300
Superficial Vein Thrombosis Testing in the Emergency Department (SVTest)
Evaluating Superficial Vein Thrombosis in the Emergency Department.
Superficial vein thrombosis (SVT) occurs when blood in a vein directly under the skin clots. SVT causes vein tenderness, pain, and skin discolouration. Over time, the vein hardens into a firm, nontender, easily palpable lump. SVT commonly occurs in the veins of the leg. Each year, 1 per 1000 people over the age of 18 have SVT. SVT is painful but usually gets better within a month. Four in 100 people with SVT develop progressively worse blood clotting involving the deep veins or lungs.
If a deep vein clot in the leg occurs it can cause permanent disability with post-thrombotic syndrome (long-term leg pain and swelling) and reduced quality of life. If a pulmonary embolism occurs it may cause chest pain, breathlessness, pulmonary hypertension, psychological distress, and potentially death. Guidelines tell doctors to use ultrasound scanning to decide whether SVT needs treatment with a blood thinner or not. Blood thinners prevent the clot from worsening.
Many people who have SVT go to the emergency department. Scanning is limited to the daytime so often people have multiple trips to the emergency department for their scan and they spend many hours waiting for a doctor to see them. Our research group developed simple ways to limit the need for scans for other types of blood clots, like blood clots in the lungs or in the deep veins. We use a simple blood test called D-dimer. We believe we may be able to use D-dimer to help limit the need for SVT scanning.
This is an exploratory study to document what happens to patients tested for SVT in the emergency department, and to see if the D-dimer blood test might be useful in reducing scans. Our research group will review the emergency department charts for patients who came to the emergency department with SVT. Our results will tell us whether further studies would be helpful.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Natasha S Clayton
- Telefonnummer: 416-566-3590
- E-post: natasha.clayton@queensu.ca
Studer Kontakt Backup
- Navn: de Wit, MD
Studiesteder
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Ontario
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Kingston, Ontario, Canada, K7L 2V7
- Emergency Medicine
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Ta kontakt med:
- Natasha S Clayton
- Telefonnummer: 416-566-3590
- E-post: natasha.clayton@queensu.ca
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Aged ≥ 18
- Tested for superficial vein thrombosis in the emergency department or urgent care centre
- Patients tested for SVT at all sites, including arms, legs and torso
Exclusion Criteria:
- Patient opted out of research at the participating site
- Patient included in the study in the last 90 days
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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Emergency department patients tested for superficial vein thrombosis
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D-dimer blood test levels will be extracted from medical records.
This is an non-interventional study.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Superficial vein thrombosis, deep vein thrombosis and no thrombosis
Tidsramme: During index testing
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SVT will be classified as a) situated within 3 cm of the deep vein junction, b) ≥ 5 cm in length and > 3 cm from the deep vein junction, and c) SVT < 5 cm in length and > 3 cm from the deep vein junction. Diagnosis of deep vein thrombosis and the finding of no thrombosis will be reported. |
During index testing
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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The secondary outcomes will the subsequent development of recurrent SVT, SVT propagation, deep vein thrombosis, pulmonary embolism, or death from pulmonary embolism among patients diagnosed with SVT at the index visit.
Tidsramme: 90 days
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90 days
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Kerstin de Wit, MD, Kingston Health Sciences Centre
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CTO5894
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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