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Hope-ICU Trial

(HalOPeridol: Effectiveness trial)

A randomised, double-blind, placebo-controlled trial to compare the early administration of intravenous haloperidol versus placebo in the prevention and treatment of delirium in critically ill ventilated patients

EudraCT Number: 2009-017842-30


REC Number: 10/H0505/65
ISRCTN 83567338
Funding Body: National Institute for Health Research

Version Number: 8

Version Date 8th April 2012



Stage: Final

Protocol Substantial Amendments:


Amendment No Date of Amendment Date of approval


  1. 9th February 2011 8th April

  2. 21st December 2012 30th January

Contact Names and Numbers


Role Name, address, telephone
Lead sponsor: West Hertfordshire Hospitals NHS Trust

Vicarage Road

Watford

WD18 0HB


Tel: 01442 213141 Ext: 2473

Email: Fiona.smith@whht.nhs.uk


Chief Investigator: Valerie Page, Consultant Critical Care

Department of Anaesthesia

Watford General Hospital

Vicarage Road

Watford

WD18 0HB


Tel: 01923 217604

Email: Valerie.page@whht.nhs.uk


Trial Co-ordinator: Ms Xiao Bei Zhao

Department of Anaesthesia

Watford General Hospital

Vicarage Road

Watford

WD18 0HB


Tel: 01923 217604

Email: ZhaoBei.Xaio@whht.nhs.uk


Trial Statistician: Dr Simon Gates

Warwick Clinical Trials Unit

University of Warwick

Tel:02476 575850

Email: s.gates@warwick.ac.uk

Health Economist Mr David Meads

University of Leeds

Leeds Institute of Health Sciences

Leeds


Tel: 0113 343 6989

Fax: 0113 246 0899

Email: D.Meads@leeds.ac.uk

Trial Steering Committee



Dr Neil Soni (Chair)

Chelsea and Westminster Hospital

Dr Danny McAuley

Royal Victoria Hospital, Belfast

Dr Valerie Page, Chief Investigator

West Hertfordshire Hospitals NHS Trust

Dr Gavin Perkins

Birmingham Heartlands Hospital

Dr Tom Stambach

West Hertfordshire Hospitals NHS Trust

Ms Fiona Smith

West Hertfordshire Hospitals NHS Trust


Dr Simon Gates

Warwick Clinical Trials Unit


Professor Wes Ely

Vanderbilt Medical Center

Nashville

Dr James Pickett

Research Grants Officer

Alzheimer’s Society




Data Monitoring and Ethics Committee

Dr Martin Kuper (Chair)

Consultant Intensive Care

Whittington Hospital NHS Trust




Dr Mike Grocott


Consultant Intensive Care

Southampton Hospitals NHS Trust


Dr Yogi Amin

Consultant Neuroanaesthetist,

University College Hospital London
Dr David Wellsted

Senior Lecturer

University of Hertfordshire

Table of Contents

Title Page

Contact Names and Details

Table of Contents

List of abbreviations
1. Lay Summary
2. Background

2.1 Terminology

2.2 Pathophysiology

2.3 Outcomes

2.4 Rationale for using haloperidol

2.4.1 Delirium treatment

2.4.2 Lack of evidence

2.4.3 Potential benefits in ICU patients

2.4.4 Delirium prevention

2.4.5 The intervention is simple and cheap

2.4.6 Acceptable tolerability and side effects

2.4.7 Dosing regimen

2.4.8 Need for a trial

2.5 Rationale for plasma -amyloid levels

2.6 Good Clinical Practice

2.7 CONSORT Guidelines


3. Trial Design

3.1 Trial Summary

3.2 Flow Diagram

3.3 Trial Objectives

3.4 Trial Outcome

3.4.1 Primary Outcome

3.4.2 Secondary Outcomes

3.4.3 Definition primary outcome

3.4.4 Rationale

3.4.5 Definition of delirium and coma

3.4.6 Safety

3.5 Eligibility criteria

3.5.1 Inclusion Criteria

3.5.2 Exclusion Criteria

3.6 Screening of Patients not suitable for Trial

3.7 Consent

3.7.1 Patient Consent

3.7.2 Personal Legal Representative Consent

3.7.3 Professional Legal Representative Consent

3.7.4 Retrospective Patient Information

3.7.5 Withdrawal of Consent

3.8 Randomisation

3.9 Trial Procedures

3.9.1 Test treatment

3.9.2 Control (placebo) Treatment

3.9.3 Treatment Preparation and Supply

3.9.4 Treatment Administration

3.9.5 Treatment Reduction

3.9.6 Treatment termination criteria

3.9.7 Treatment compliance

3.9.8 Drug Accountability

3.9.10 Blood Sampling Mechanisms

3.10 Clinical Management of Patients in the Trial

3.10.1 Rescue protocol for delirium

3.10.2.Sedation Management

3.10.3 Extrapyramidal Symptoms

3.10.4 Prolonged QTc

3.10.5 Blinding and procedures for unblinding

3.11 Post treatment follow-up

3.12 Pharmacovigilance

3.12.1 Definition of Adverse Events

3.12.2 Assessment of causality

3.12.3 Adverse Event reporting period

3.12.4 Adverse Event reporting requirements

3.12.5 Adverse Event reporting

3.12.6 Serious Adverse Event reporting

3.13 End of Trial
4 Data Management

4.1 Training Issues

4.2 Data Collection and Management

4.3.Follow-up at 6 months

4.4 Data Storage

4.5 Archiving


5. Data Analysis

5.1 Sample Size Calculation

5.2 Statistical Analysis

5.3 Economic Evaluation


6. Trial Organisation

6.1 Sponsor

6.2 Trial Steering Committee (TSC)

6.3 Data Monitoring and Ethics Committee (DMEC)

6.3.1 Safety

6.4 Administration

6.5 Indemnity

6.6 Monitoring and Safety Procedures

6.7 Safety and well being of study subjects

6.8 Safety of Investigators


7. Ethics and Regulatory Approval
8. Protocol Amendments
9. Publication
10. References

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