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NCT00516126 Clinical Trial

Goal-orientated Therapy of Perioperative Disturbance in Hemostasis in Cardiac Surgery

Blood Coagulation Disorders Clinical Trial

Official title:
Goal-orientated Therapy of Perioperative Disturbance in Hemostasis With MULTIPLATE and ROTEM in Cardiac Surgery Patients Under Platelets Inhibitors

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00516126
Other study ID # 194/06
Secondary ID
Status Completed
Phase Phase 4
First received August 13, 2007
Last updated January 10, 2013
Start date June 2009
Est. completion date December 2011

Study information
Verified date January 2013
Source University Hospital, Basel, Switzerland
Contact n/a
Is FDA regulated No
Health authority Switzerland: Swissmedic
Study type Observational

Clinical Trial Summary

Aim of this study is to investigate whether patients preoperatively treated with acetylsalicylic acid and/or clopidogrel have fewer perioperative bleeding and lower amounts of blood substitution when managed by ROTEM (whole blood coagulation analyzer) and MULTIPLATE (thrombocyte function analyzer).

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date December 2011
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- written consent

Exclusion Criteria:

- no written consent

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Switzerland University Hospital Basel Basel CH

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Perioperative blood loss 24 hours No
Secondary perioperative substitution with erythrocyte concentrates, thrombocyte concentrates or fresh frozen plasma 24 hours and 7 days No
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