- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00656396
Point of Care Coagulation Testing in Patients Undergoing Major Surgery (POC-OP)
7 september 2015 uppdaterad av: University of Bern
Does Point of Care Coagulation Testing Reduce the Transfusion of Non-erythrocyte Blood Products in Patients Undergoing Major Surgery? A Randomized-Controlled Trial
Bleeding is a frequent complication during surgery.
The peri-operative administration of blood products, including packed red blood cells, thrombocytes and fresh frozen plasma (FFP), is often deemed necessary.
Therefore the transfusion of allogenic blood products mandates strategies to optimize the clinical decision to transfuse.
The decision to administer FFP is usually made in the absence of any data.
Point of care testing of prothrombin time ensures that a major parameter of coagulation is readily available.
The test is fast, easy to perform, inexpensive and may enable physicians to rationally determine the need for FFP.
Objective of the study is to determine the effectiveness of point of care coagulation testing of prothrombin time to reduce the administration of FFP.
Studieöversikt
Status
Avslutad
Betingelser
Detaljerad beskrivning
Background: Bleeding is a frequent complication during surgery.
The peri-operative administration of blood products, including packed red blood cells, thrombocytes and fresh frozen plasma (FFP), is often deemed necessary.
Beside the expenses of blood products these products carry risks of infection, allergic reaction and immune-modulation.
Therefore the transfusion of allogenic blood products mandates strategies to optimize the clinical decision to transfuse.
Bleeding during surgery is a dynamic process; it can happen within minutes and result not only in major blood loss, but also in coagulation aberrations.
The indication for a transfusion should be based on reliable coagulation studies.
Traditional coagulation studies require up to 1 hour.
Therefore, the decision to administer FFP is usually made in the absence of any data.
Point of care testing of prothrombin time ensures that a major parameter of coagulation is readily available in the operation theatre within 3 minutes.
It is fast, easy to perform, inexpensive and may enable physicians to rationally determine the need for FFP.
Objective: To determine the effectiveness of point of care coagulation testing of prothrombin time to reduce the administration of FFP.
Methods: Patient and assessor blind, single center randomized controlled parallel group trial in 220 patients aged between 18 and 90 years undergoing major surgery (any type, except cardiac surgery and liver transplant) with an estimated blood loss during surgery exceeding 20% of the calculated normal total blood volume or a requirement of FFP according to the judgment of treating surgeons or anesthesiologists.
Patients will be randomized to usual care plus point of care coagulation testing or usual care alone without point of care testing.
Primary endpoint will be the relative risk to receive any FFP peri-operatively.
Significance: Point of care coagulation testing in the operation theatre may reduce the administration of fresh frozen plasma considerably, which in turn may decrease costs and complications usually associated with the administration of allogenic blood products.
Studietyp
Interventionell
Inskrivning (Faktisk)
228
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
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Bern, Schweiz, 3010
- University Hospital Bern
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 90 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Age between 18 and 90 years
- Major surgery
- Estimated blood loss during surgery > 20% of individual blood volume of 70ml per kg body weight
- Patients requiring FFP
Exclusion Criteria:
- Known hereditary coagulopathy
- Liver transplant
- Cardiac surgery
- Pregnancy
- Preoperative hemoglobin <100g/l
- Abnormal coagulation studies before surgery
- Active treatment with drugs inhibiting coagulation or platelet function
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Control
Standard care
|
Standard care
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Experimentell: Intervention
Point of care monitoring used
|
Coagucheck XS Plus® is used for intraoperative measurement of Prothrombin time
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
The relative risk to receive any FFP peri-operatively.
Tidsram: at post-operative discharge from hospital, estimated to be about 5 days after randomisation
|
at post-operative discharge from hospital, estimated to be about 5 days after randomisation
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Number of units of FFP received between randomization and post-operative discharge from hospital
Tidsram: at post-operative discharge from hospital, estimated to be about 5 days after randomisation
|
at post-operative discharge from hospital, estimated to be about 5 days after randomisation
|
The relative risk of major in-hospital bleeding defined as bleeding event requiring an extension of hospitalization, reoperation due to bleeding, bleeding resulting in hemorrhagic shock or death
Tidsram: at post-operative discharge from hospital, estimated to be about 5 days after randomisation
|
at post-operative discharge from hospital, estimated to be about 5 days after randomisation
|
The relative risk of an APTC event (non-fatal myocardial infarction, non-fatal stroke, cardiovascular death, or death of unknown cause) between randomization and post-operative discharge from hospital
Tidsram: at post-operative discharge from hospital, estimated to be about 5 days after randomisation
|
at post-operative discharge from hospital, estimated to be about 5 days after randomisation
|
The relative risk of overall mortality between randomization and post-operative discharge from hospital
Tidsram: at post-operative discharge from hospital, estimated to be about 5 days after randomisation
|
at post-operative discharge from hospital, estimated to be about 5 days after randomisation
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: Robert Greif, MD MME, Departement of Anesthesiology and Pain Therapy, Bern University Hospital
- Huvudutredare: Natalie Urwyler, MD, Bern University Hospital
- Studiestol: Peter Jüni, PD Dr med, CTU Bern, Bern University Hospital, and Institute of Social and Preventive Medicine, University of Bern
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 maj 2008
Primärt slutförande (Faktisk)
1 september 2011
Avslutad studie (Faktisk)
1 september 2011
Studieregistreringsdatum
Först inskickad
7 april 2008
Först inskickad som uppfyllde QC-kriterierna
10 april 2008
Första postat (Uppskatta)
11 april 2008
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
9 september 2015
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
7 september 2015
Senast verifierad
1 september 2015
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- KEK 232_06
- 232_06 (Annan identifierare: KEK)
- 3200B0_122461 (Annat bidrag/finansieringsnummer: SNF)
- 1295 (Inselspital)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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