Condition category
Injury, Occupational Diseases, Poisoning
Date applied
06/11/2005
Date assigned
03/02/2006
Last edited
03/02/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Boke Linse Sjirk Borger van der Burg

ORCID ID

Contact details

Bronovolaan 4
The Hague
2597 AX
Netherlands
+31 (0)703124141
boudewijn.borgervanderburg@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00250237

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

In this study we want to determine if treatment with haloperidol directly after acute hip surgery in high risk patients protects against developing a post-operative delirium.

Ethics approval

Yes, Medical Ethics Committee Southwest Holland (Medisch Ethische Toetsingscommissie [METC] Zuidwest Holland). Date of approval: September 2nd 2005.
METC number: 05-56.

Study design

Randomised double-blind placebo-controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Hip fracture

Intervention

Post-operative Haloperidol versus Placebo

Intervention type

Drug

Phase

Not Specified

Drug names

Haloperidol

Primary outcome measures

Incidence of post-operative delirium

Secondary outcome measures

1. Mortality
2. Activities of daily living (ADL) dependency

Overall trial start date

10/11/2005

Overall trial end date

10/11/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients aged 75 years and older
2. Hip Fracture

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

206

Participant exclusion criteria

1. Younger patients
2. Pre-operative delirium
3. Contra-indications for use of haloperidol

Recruitment start date

10/11/2005

Recruitment end date

10/11/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

Bronovolaan 4
The Hague
2597 AX
Netherlands

Sponsor information

Organisation

Research Fund Bronovo Hospital (The Netherlands)

Sponsor details

Bronovolaan 5
The Hague
2597 AX
Netherlands
+31 (0)703124141
sgieskes@bronovo.nl

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Research Fund Bronovo Hospital

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes