Condition category
Circulatory System
Date applied
31/07/2004
Date assigned
01/04/2005
Last edited
14/11/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.helpstudy.org/

Contact information

Type

Scientific

Primary contact

Dr Philip White

ORCID ID

Contact details

Dept. of Neuroradiology
Western General Hospital
Crewe Road
Edinburgh
EH4 2XU
United Kingdom
pmw@skull.dcn.ed.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

HELPS

Study hypothesis

The HELPS (hydrocoil: endovascular aneurysm occlusion and packing study) trial aims to compare major aneurysm recurrence rate on follow-up angiography at 15 - 18 months between patients allocated hydrocoil versus patients allocated bare platinum coiling.

Ethics approval

Not provided at time of registration.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Patient information sheet can be found at http://www.mymainplace.com/HelpStudy/Collateral/PIS%20V3.doc.

Condition

Intracranial aneurysms

Intervention

This study is now closed to recruitment.

Patients are randomised to the hydrogel coil or control arms by using concealed allocation with minimisation matching groups. Any bare platinum coils are allowed in the control arm, and assist devices could be used as clinically required.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Angiographic outcomes at 15-18 months between aneurysms coiled using bare platinum coils (control group) and those coiled using hydrocoil embolic system.

Secondary outcome measures

Secondary outcome measures include packing density, clinical outcome, rebleed and retreatment comparisons between these 2 groups.

Overall trial start date

01/09/2004

Overall trial end date

30/06/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Patient presenting with a cerebral aneurysm deemed to require endovascular treatment by the neurosurgeon/neurointerventionist (generically referred to subsequently as 'the neurovascular team'), and:
1. Patient has given fully informed consent to endovascular coiling procedure
2. Aneurysm 2 - 25 mm in maximum diameter
3. Anatomy such that endovascular occlusion is deemed possible (not necessarily probable)
4. The neurointerventionist is content to use either bare platinum or hydrocoil embolic system (HES) depending on randomisation result (i.e., clinical equipoise principle applies)
5. The neurointerventionist is content not to use any other type of coated coil
6. Patient World Federation of Neurological Surgeons (WFNS) Grade 0 - 2 and aged 18 - 75 years
7. The patient has not been previously randomised into this trial
8. Aneurysm has not previously been treated (by coiling or clipping)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

500

Participant exclusion criteria

Subjects will not be considered for the trial unless they meet all the inclusion criteria. If the patient has more than one aneurysm requiring treatment at the same treatment episode they will not be eligible for the trial. If treatment will be staged in a patient with multiple aneurysms and only one aneurysm will be treated at one sitting then the patient is eligible. However, a patient may not be randomised into the study more than once.

From the moment of randomisation, the patient is in the trial whether they receive trial treatment or not, and will be followed up and accounted for in the final analysis (intention-to-treat).

Death or procedural/disease related morbidity may result in some subjects not having check angiography (or magnetic resonance angiography [MRA] if unit uses this as standard mode of follow-up). These patients will be counted as poor outcomes in the primary analysis.

Retreatment of previously coiled or clipped aneurysm is an exclusion criteria.

Use of coil assist devices (stent, balloon, trispan etc.) should be recorded but is not an exclusion criteria. It must be recorded in order to ascertain if any difference in use between control and hydrocoil groups acts as a potential confounding variable.

Recruitment start date

01/09/2004

Recruitment end date

30/06/2008

Locations

Countries of recruitment

Argentina, Australia, Brazil, France, Germany, United Kingdom, United States of America

Trial participating centre

Dept. of Neuroradiology
Edinburgh
EH4 2XU
United Kingdom

Sponsor information

Organisation

Lothian University Hospitals Division (UK)

Sponsor details

Research & Development Office
Room G8137
Royal Infirmary of Edinburgh
Little France Crescent
Edinburgh
EH16 4SA
United Kingdom
neil.feltham@luht.scot.nhs.uk

Sponsor type

Hospital/treatment centre

Website

http://www.research.luht.scot.nhs.uk/

Funders

Funder type

Industry

Funder name

Microvention Incorporated (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Lothian University Hospitals Division (UK)

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

1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18184832
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21571149

Publication citations

  1. Results

    White PM, Lewis SC, Nahser H, Sellar RJ, Goddard T, Gholkar A, , HydroCoil Endovascular Aneurysm Occlusion and Packing Study (HELPS trial): procedural safety and operator-assessed efficacy results., AJNR Am J Neuroradiol, 2008, 29, 2, 217-223, doi: 10.3174/ajnr.A0936.

  2. Results

    White PM, Lewis SC, Gholkar A, Sellar RJ, Nahser H, Cognard C, Forrester L, Wardlaw JM, , Hydrogel-coated coils versus bare platinum coils for the endovascular treatment of intracranial aneurysms (HELPS): a randomised controlled trial., Lancet, 2011, 377, 9778, 1655-1662, doi: 10.1016/S0140-6736(11)60408-X.

Additional files

Editorial Notes