A trial to determine the Optimal TR-Band Deflation Time (ORBIT) in patients undergoing diagnostic or interventional coronary procedures

Not Applicable

• Conditions: Coronary Heart Disease; Bleeding; Haemostasis; Cardiovascular - Coronary heart disease

• Registration Number: ACTRN12616000550404
• Lead Sponsor: Deakin University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-28
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 548

Inclusion Criteria

1. Any patient undergoing diagnostic coronary angiography or percutaneous coronary intervention;
2. Use of a 6F radial artery sheath for access; and
3. Intra-procedural administration of 5000 units of heparin.

Exclusion Criteria

1.Concomitant use of other arterial access sites;
2.Patient has received thrombolytic therapy up to 12 hours prior to sheath removal;
3.Patient has received Gp IIb/IIIa antagonists up to 24 hours prior to sheath removal;
4.Estimated glomerular filtration rate (eGFR, based on the Modification of Diet in Renal Disease criteria) less than 30 mL/min per 1.73 m2;
5.Patient has received subcutaneous enoxaparin up to 12 hours prior to sheath removal when eGFR is known to be greater than 35mL/min/1.73 m2;
6.Patient has received subcutaneous enoxaparin up to 24 hours prior to sheath removal when eGFR is known to be equal to 35mL/min/1.73 m2;
7.Patient has received heparin up to 6 hours prior to sheath removal
8.Platelet count less than 100 x1^9/L;
9.Prothrombin ratio (PR) or international normalized ratio (INR) greater than 1.5 at the time of the procedure;
10.Activated partial thromboplastin time (APTT) greater than 45 seconds at the time of the procedure; and/or
11.Patient is unable to give informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified