Prothrombotic changes during aortic valve management

Not Applicable

Completed

• Conditions: transcatheter aortic valve implantation; percutaneous coronary intervention; aortic valve replacement; thrombosis; bleeding; Anaesthesiology - Anaesthetics; Cardiovascular - Other cardiovascular diseases; Surgery - Other surgery

• Registration Number: ACTRN12619000080123
• Lead Sponsor: St. Andrew's War Memorial Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-21
• Study Completion: 2019-12-23
• Last Update Posted: 27 April 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified