- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00264095
An Observational Study of Blood Management Techniques in Oncology Surgical Treatment
25. april 2014 opdateret af: Janssen-Cilag B.V.
Blood Management Observation in Oncology Surgical Treatment (BOOST)
The purpose of this study is to observe the methods used to manage blood loss in surgical procedures to remove tumors from patients with cancer and to determine if there is a relationship with the need for blood transfusions.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Considerable blood loss typically accompanies surgical procedures to remove malignant tumors.
Blood transfusions, the best method of compensating for blood loss during surgery, have associated medical risks including infection transmission and allergic reaction, in addition to using significant amounts of red blood cells, which are often in short supply.
Options exist to manage blood loss before surgery, including a procedure where a patient's own blood is stored in advance to be given if needed during surgery, and drug intervention, where a drug is given before surgery to help increase red blood cell production, thereby maintaining hemoglobin and oxygen levels in the body during surgery.
This is a multi-center observational study to collect information regarding the methods used to manage blood loss in patients undergoing surgical removal of malignant tumors in the Netherlands.
Information will be collected by study center and by patient over the course of approximately 18 months.
For study center information, each observation period will last 2 months and there will be at least a 2-month interval between each observation period.
For patient information there is one continuous observation period.
General information regarding the frequency of use of different blood-saving techniques for the various types of operations performed will be collected from each of the centers participating in the study.
Data obtained at the onset of the study will be compared to follow-up data gathered throughout the additional reporting periods and trends or changes in frequency of use of blood-saving techniques will be noted.
The following information will be collected: medical history, tumor stage, type/site of operation, anticipated vs. actual blood loss during surgery, most recent hemoglobin and hematocrit values prior to the operation, blood-saving techniques used and the number of units and types of blood transfusions up to 24 hours after the operation.
Information will be obtained from patients' medical records.
No medication will be supplied by the study Sponsor and no specific procedures will be required for the study.
Each patient's surgeon and anesthesiologist will be responsible for all decisions regarding his/her care and treatment during the operation.
Information may be collected a maximum of one time from each patient during this study and there will be no follow-up information collected from individual patients.
Since the study involves only the collection of information, no treatment will be required by the Sponsor and no medication will be supplied by the Sponsor.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
488
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Alkmaar, Holland
-
Amersfoort, Holland
-
Apeldoorn, Holland
-
Deventer, Holland
-
Dordrecht, Holland
-
Drachten, Holland
-
Nieuwegein, Holland
-
Nijmegen, Holland
-
Roosendaal, Holland
-
Sneek, Holland
-
Zwolle, Holland
-
-
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 with a malignant tumour for which surgery is the primary treatment and a minimal blood loss of 500 ml.
and a maximum blood loss of 3000 ml. is expected.
Beskrivelse
Inclusion Criteria:
- Patients with a malignant tumor for which surgery is the first treatment
- Having an expected blood loss of at least 500 ml (100 teaspoons), and not more than 3000 ml (600 teaspoons)
Exclusion Criteria:
- Patients with a malignant tumor for which surgery is not the first treatment (i.e. have received chemotherapy first)
- Inability to speak, read and write Dutch
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
---|---|
001
|
surgery is primary observed intervention and blood loss is between 500-3000 ml
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Patients' medical history; tumor stage; type/site of operation; anticipated vs. actual blood loss; hemoglobin/hematocrit values prior to surgery, blood-saving techniques used; number of units and types of blood transfusions up to 24 hours after surgery
Tidsramme: 24 hours after surgery
|
24 hours after surgery
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Frequency of use of different blood-saving techniques for the various types of operations performed from each of the centers participating in the study
Tidsramme: within 24 hours after surgery
|
within 24 hours after surgery
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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. juli 2004
Primær færdiggørelse (Faktiske)
1. februar 2006
Studieafslutning (Faktiske)
1. februar 2006
Datoer for studieregistrering
Først indsendt
9. december 2005
Først indsendt, der opfyldte QC-kriterier
9. december 2005
Først opslået (Skøn)
12. december 2005
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
28. april 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
25. april 2014
Sidst verificeret
1. april 2014
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CR003460
- EPOSUR4001
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 .
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