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Clinical Trials/ACTRN12619000080123
ACTRN12619000080123
Completed
未知

Characterising the prothrombotic changes associated with transcatheter aortic valve implantation: the key to promoting the rational use of anti-thrombotic prophylaxis and minimizing devastating thromboembolic and bleeding complications

St. Andrew's War Memorial Hospital0 sites40 target enrollmentJanuary 21, 2019

Overview

Phase
未知
Intervention
Not specified
Conditions
transcatheter aortic valve implantation
Sponsor
St. Andrew's War Memorial Hospital
Enrollment
40
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 21, 2019
End Date
December 23, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
St. Andrew's War Memorial Hospital

Eligibility Criteria

Inclusion Criteria

  • 1\) Informed consent for participation;
  • 2\) Either: i) severe aortic stenosis (aortic valve area \<0\.8cm2, mean aortic valve gradient \>40mmHg or peak jet velocity \>4m/s); AND planned management with either a TF\-TAVI or isolated AVR; OR, ii) Non\-ST elevation myocardial infarction (new ischaemic ECG criteria, troponin \> upper limit of normal, clinical symptoms); AND planned management with elective PCI; 3\) Stable haemoglobin \> 100g/l; 4\) Non\-emergency procedure; 5\) Preserved ejection fraction (\>50%).

Exclusion Criteria

  • 1\) Lack of capacity to consent for him or herself; 2\) Medications known to: i) interact with coagulation assays; or ii) have a known or suspected prothrombotic or coagulopathic action that cannot be corrected for by the analysers used for point of care coagulation testing; 3\) Known or suspected bleeding or clotting disorders; 4\) Severe liver, renal, respiratory or psychiatric disease (including substance abuse); 5\) Enrolled in another study with a non\-standard treatment intervention.

Outcomes

Primary Outcomes

Not specified

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