NCT00516126

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 14, 2007

Completed
1.8 years until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

January 11, 2013

Status Verified

January 1, 2013

Enrollment Period

2.5 years

First QC Date

August 13, 2007

Last Update Submit

January 10, 2013

Conditions

Coronary Artery Bypass Graft Triple VesselBlood Coagulation Disorders

Keywords

hemostasis monitoringperioperative blood loss

Outcome Measures

Primary Outcomes (1)

  • Perioperative blood loss

    24 hours

Secondary Outcomes (1)

  • perioperative substitution with erythrocyte concentrates, thrombocyte concentrates or fresh frozen plasma

    24 hours and 7 days

Study Arms (2)

Point-of-Care managed

This arm includes all patients in which the hemostatic therapy is guided by POC devices e.g. MULTIPLATE (a platelet function analyzer) or ROTEM (thromboelastometry)

Conventional hemostasis lab managed

This arm includes all patients in which the hemostatic therapy is guided by conventional hemostasis laboratory data e.g. INR, aPTT, fibrinogen concentration, platelet count but no POC devices e.g. MULTIPLATE (a platelet function analyzer) or ROTEM (thromboelastometry)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing cardiac surgery

You may qualify if:

  • written consent

You may not qualify if:

  • no written consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel

Basel, CH, 4031, Switzerland

Location

MeSH Terms

Conditions

Blood Coagulation Disorders

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Miodrag Filipovic, PhD, MD

    Department of Anesthesia, University Hospital Basel, CH-4031 Basel, Switzerland

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr. Daniel Bolliger

Study Record Dates

First Submitted

August 13, 2007

First Posted

August 14, 2007

Study Start

June 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

January 11, 2013

Record last verified: 2013-01

Locations

CH(1)