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Point of Care Coagulation Testing in Patients Undergoing Major Surgery

NCT00656396 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 228

Last updated 2015-09-09

No results posted yet for this study

Summary

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.

Conditions

  • Blood Loss, Surgical

Interventions

DEVICE

Coagucheck XS Plus (Point of care monitor of coagulation intraoperative)

Coagucheck XS Plus® is used for intraoperative measurement of Prothrombin time

PROCEDURE

Control Intervention

Standard care

Sponsors & Collaborators

  • University of Bern

    lead OTHER

Principal Investigators

  • Robert Greif, MD MME · Departement of Anesthesiology and Pain Therapy, Bern University Hospital

  • Natalie Urwyler, MD · Bern University Hospital

  • Peter Jüni, PD Dr med · CTU Bern, Bern University Hospital, and Institute of Social and Preventive Medicine, University of Bern

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00656396 on ClinicalTrials.gov