BAIL-OUT: 'Bail-out Anticoagulation in coronary Intervention TriaL - OUTcomes': a randomised comparison of the real world use of bivalirudin versus abciximab as a 'bail out' anticoagulant following heparin in percutaneous coronary intervention with focus on patient safety
| ISRCTN | ISRCTN98978563 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN98978563 |
| Clinical Trials Information System (CTIS) | 2006-003343-23 |
| Protocol serial number | UHL 10145 |
| Sponsor | University Hospitals of Leicester NHS Trust (UK) |
| Funders | University Hospitals of Leicester NHS Trust (UK), Nycomed UK Ltd (UK) will provide a small research grant (to cover consumables and admin costs); Nycomed have no rights to any future publications or input into design or conduct of the study |
- Submission date
- 07/09/2006
- Registration date
- 04/01/2007
- Last edited
- 10/07/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Anthony Gershlick
Scientific
Scientific
Clinical Sciences Department
Glenfield Hospital
Groby Road
Leicester
LE3 9QP
United Kingdom
| Phone | +44 (0)116 256 3021 |
|---|---|
| agershlick@aol.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre open-label randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | BAIL-OUT: 'Bail-out Anticoagulation in coronary Intervention TriaL - OUTcomes': a randomised comparison of the real world use of bivalirudin versus abciximab as a 'bail out' anticoagulant following heparin in percutaneous coronary intervention with focus on patient safety |
| Study acronym | BAIL-OUT |
| Study objectives | Non-inferiority exists in terms of bleeding complication rates between bivalirudin and abciximab (ReoPro) when used as provisional (Bail-out) anticoagulants during Percutaneous Coronary Intervention (PCI). |
| Ethics approval(s) | Leicestershire, Northamptonshire and Rutland REC 1, 13/10/2006, ref: 06/Q2501/197 |
| Health condition(s) or problem(s) studied | Coronary artery disease |
| Intervention | Provisional bivalirudin versus provisional Abciximab following bolus heparin (65 u/kg) during PCI. The trial anticoagulant is given as per normal protocol, i.e., Bivalirudin bolus 0.75 mg/kg followed by infusion of 1.75 mg/kg/hr for duration of procedure only and Abciximab bolus and infusion for 12 hours. Data collected from baseline, day of discharge post PCI and 30 days post PCI. |
| Intervention type | Drug |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Bivalirudin, abciximab (ReoPro), heparin |
| Primary outcome measure(s) |
Major and minor bleeding complication rate |
| Key secondary outcome measure(s) |
1. Major Adverse Coronary Events (MACE) |
| Completion date | 01/04/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 100 |
| Key inclusion criteria | Patients undergoing planned elective PCI at Leicester Glenfield Hospital without requirement for up-front GlycoProtein (GP) IIb IIIa after consent from patient and operator, randomised when Bail out situation is deemed to have occurred by the operator, which requires additional anticoagulation. There will be no limitation of concomitant therapy. All therapeutic regimens will be documented on the Case Report Form (CRF). Indications for additional anticoagulation (and hence randomisation) will include but not be restricted to: 1. Abrupt or side-branch closure 2. Obstructive dissection 3. New or suspected thrombus 4. Impaired or slow coronary blood flow 5. Distal embolisation of thrombus 6. Persistent residual stenosis 7. Unplanned stent placement 8. Prolonged ischaemia 9. Other clinical instability or at discretion of the operator |
| Key exclusion criteria | 1. Any contra-indication to Bivalirudin or ReoPro as per product licence 2. Primary PCI for acute myocardial infarction 3. Uncontrolled sustained Blood Pressure (BP) more than 200/110 mmHg 4. Previous PCI within one month 5. Active bleeding, surgery, trauma or Gastro-Intestinal (GI) bleeding within 6/52 6. Serious intracranial pathology or previous bleed 7. Disseminated malignancy 8. Potential bleeding diathesis or other contra-indication to anticoagulation 9. Platelet count less than 100 10. Serum creatinine more than 350 or dialysis dependent 11. Abciximab within seven days, eptifibitide or tirofiban within 12 hours 12. Any other medical condition, or the presence of extreme age or general frailty which would lead operator to reduce dose or omit anticoagulants in normal practice |
| Date of first enrolment | 01/11/2006 |
| Date of final enrolment | 01/04/2008 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Glenfield Hospital
Leicester
LE3 9QP
United Kingdom
LE3 9QP
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
10/07/2017: No publications found, verifying study status with principal investigator.
