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
EudraCT/CTIS number	2006-003343-23
Secondary identifying numbers	UHL 10145

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

Clinical Sciences Department
Glenfield Hospital
Groby Road
Leicester
LE3 9QP
United Kingdom

Phone	+44 (0)116 256 3021
Email	agershlick@aol.com

Study information

Study design	Single-centre open-label randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient 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
Pharmaceutical study type(s)
Phase	Phase IV
Drug / device / biological / vaccine name(s)	Bivalirudin, abciximab (ReoPro), heparin
Primary outcome measure	Major and minor bleeding complication rate
Secondary outcome measures	1. Major Adverse Coronary Events (MACE) 2. Peri-procedural Troponin T level
Overall study start date	01/11/2006
Completion date	01/04/2008

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	50 per group = 100 patients
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

England
United Kingdom

Study participating centre

Glenfield Hospital

Leicester
LE3 9QP
United Kingdom

Sponsor information

University Hospitals of Leicester NHS Trust (UK)
Hospital/treatment centre

c/o Professor David Rowbotham
Trust Headquarters
Gwendolen House
Gwendolen Road
Leicester
LE5 4QF
England
United Kingdom

Phone	+44 (0)115 249 0490
Email	djr8@le.ac.uk
Website	http://www.uhl-tr.nhs.uk/
"ROR"	https://ror.org/02fha3693

Funders

Funder type

Government

University Hospitals of Leicester NHS Trust (UK)

No information available

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

10/07/2017: No publications found, verifying study status with principal investigator.