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Platelet reactivity and post-operative myocardial injury after major non-cardiac surgery (PROMISE).

Completed
Conditions
asymptomatic postoperative troponin elevation
heart injury after surgery
Myocardial injury after noncardiac surgery
10003184
Registration Number
NL-OMON47812
Lead Sponsor
Sint Antonius Ziekenhuis
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
60
Inclusion Criteria

Patient must meet ALL of the following criteria:
* Males or females > 21 years of age and < 85 years
* Undergoing elective open abdominal vascular surgery
* On pre-operative ascal maintenance therapy

Exclusion Criteria

1) Patients who are unable to give informed consent or have life expectancy of < 1year
2) Subjects who have received thrombolytic therapy within 24 hours or GpIIb/IIIa-inhibitors within last 30 days
3) Subjects who had an acute coronary syndrome within the last 30 days
4) Subjects with a contra-indication to anticoagulation or at increased bleeding risk
a. Past or present history (<1 year) of bleeding from gastrointestinal (haematemesis) melena, frank bleed in stool or visible haematuria
b. Known platelet count (<100,00/mm3 ) or coagulopathy or platelet disorder
c. History of major recent (<30 day) surgery or trauma
5) Known Hb <6.5 mmol/L11g/dl or HCT <33%

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Peak postoperative cardiac troponin level</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Length of stay, myocardial infarction, stroke, death during hospital stay. </p><br>
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