- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02017743
Effectiveness And Safety of LMWH Treatment in Cancer Patients Diagnosed With Non-High Risk Venous Thromboembolism (TREBECA)
16. december 2013 opdateret af: Trio Grup Clinical Research
Effectiveness And Safety of LMWH Treatment in Cancer Patients Diagnosed With Non-High Risk Venous Thromboembolism - An Observational Study
This study is a multicenter post authorization observational study.
Cancer patients diagnosed with non high risk VTE and are followed up in an outpatient setting will be treated with LMWH and the data will be recorded.
Since this is an observational study there are no specific treatment protocols, i.e., patients will be treated according to the best investigator's criteria.
Treatment protocol will be based on the routine treatment practice of the involved investigator.
Patients to enroll will be cancer patients diagnosed for VTE and who are able to receive outpatient LMWH treatment.
There will be no specific hypothesis to be tested.
Studieoversigt
Status
Ukendt
Betingelser
Detaljeret beskrivelse
Inclusion criteria
- 18 years or upper age
- A signed informed consent document
- Cancer patient diagnosed for VTE
- Life expectancy > 6 months
- Eligible for criteria of outpatient administration of LMWH
Exclusion criteria
• Should not carry any medical situation listed below, that outpatient administration of LMWH might be risky :
- Patients with active bleeding or at-risk for bleeding
- Major surgery in the last 7 days
- Cardiopulmonary unstability
- Severe systemic venous occlusion
- Patients at high risk for pulmonary embolism
- Thrombocytopenia (<50000/microliter)
- Inpatients under medical or surgery supervision
- Patients with low ability to communicate and for whom it is not possible to provide care at home
- INR≥1.5 due to liver functions impairment
- Diagnosed for cerebral vascular aneurism
- Active gastric and/or duodenum ulcer
- Diagnosed for bacterial endocarditis
- Severe renal function impairment (Creatinine clearance < 30 ml/min)
- Grade 3 hypertension (DBP >= 110 mmHg and/or SBP >= 180 mmHg)
- <35 kg or ≥110 kg weight
- Known allergy to heparin and/or its derivatives
- History of cerebrovascular event in the last 1 month
- Active haemorrhage within the last 3 months
Undersøgelsestype
Observationel
Tilmelding (Forventet)
200
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Metin Ozkan, Prof
- E-mail: metino@erciyes.edu.tr
Undersøgelse Kontakt Backup
- Navn: Ilker Kurkcu, Pharm
- E-mail: ilker.kurkcu@triogrup-cro.com
Studiesteder
-
-
Melikgazi
-
Kayseri, Melikgazi, Kalkun
- Rekruttering
- Erciyes University Faculty of Medicine
-
Kontakt:
- Metin Ozkan, Prof
- E-mail: metino@erciyes.edu.tr
-
Ledende efterforsker:
- Metin Ozkan, Prof
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Patients to enroll will be cancer patients diagnosed for VTE and who are able to receive outpatient LMWH treatment.
Beskrivelse
Inclusion Criteria:
- 18 years or upper age
- A signed informed consent document
- Cancer patient diagnosed for VTE
- Life expectancy > 6 months
- Eligible for criteria of outpatient administration of LMWH
Exclusion Criteria:
- Patients with active bleeding or at-risk for bleeding
- Major surgery in the last 7 days
- Cardiopulmonary unstability
- Severe systemic venous occlusion
- Patients at high risk for pulmonary embolism
- Thrombocytopenia (<50000/microliter)
- Inpatients under medical or surgery supervision
- Patients with low ability to communicate and for whom it is not possible to provide care at home
- INR≥1.5 due to liver functions impairment
- Diagnosed for cerebral vascular aneurism
- Active gastric and/or duodenum ulcer
- Diagnosed for bacterial endocarditis
- Severe renal function impairment (Creatinine clearance < 30 ml/min)
- Grade 3 hypertension (DBP >= 110 mmHg and/or SBP >= 180 mmHg)
- <35 kg or ≥110 kg weight
- Known allergy to heparin and/or its derivatives
- History of cerebrovascular event in the last 1 month
- Active haemorrhage within the last 3 months
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Evaluation of effectiveness of LMWH used in the treatment of thrombosis in cancer patients with VTE regarding new thrombosis.
Tidsramme: [Time to new thrombosis in 15 days]
|
[Time to new thrombosis in 15 days]
|
Evaluation of effectiveness of LMWH used in the treatment of thrombosis in cancer patients with VTE regarding resolution.
Tidsramme: [Time to resolution in 15 days]
|
[Time to resolution in 15 days]
|
Evaluation of effectiveness of LMWH used in the treatment of thrombosis in cancer patients with VTE regarding bleeding
Tidsramme: [Time to bleeding in 15 days]
|
[Time to bleeding in 15 days]
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Metin Ozkan, Prof., Erciyes University Faculty of Medicine
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. december 2012
Primær færdiggørelse (Forventet)
1. august 2014
Studieafslutning (Forventet)
1. august 2014
Datoer for studieregistrering
Først indsendt
5. december 2013
Først indsendt, der opfyldte QC-kriterier
16. december 2013
Først opslået (Skøn)
23. december 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
23. december 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. december 2013
Sidst verificeret
1. december 2013
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- TREBECA
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .