Condition category
Haematological Disorders
Date applied
11/03/2011
Date assigned
17/06/2011
Last edited
26/11/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Intra-cranial haemorrhage (bleeding inside the skull) is the most serious type of bleed caused by a very low platelet count. Intra-cranial haemorrhage (ICH) is rare but can have devastating consequences, sometimes leading to death or long-term disability. We do not know why some patients with a very low platelet count bleed and others do not bleed. The main aim of this study is to identify possible risk factors for this type of bleeding. Other aims of the study are to look at the short-term outcomes for these patients (30 days after the ICH) and to produce a more accurate estimate of how often ICH occurs in this particular group of patients. This study is collecting data specifically from patients with haematological disorders (typically those who have been diagnosed with cancer of the blood) who are being treated with chemotherapy or a stem cell transplant.

Who can participate?
Patients must be 16 years old or over and be receiving treatment intended to cure their disease.

What does the study involve?
Participating centres are sent monthly report cards for them to indicate if their centre has or has not observed any ICH that month. All information is completely anonymised (all personal identifiable data is removed) before being sent to the study team. No identifiable information is ever collected as part of this study. The study does not involve any active participation from patients. We are collecting information about an event (the ICH) that has already occurred; it does not affect or influence treatment or care in any way.

What are the possible benefits and risks of participating?
Collecting and analysing anonymised information is a useful research method and can lead to a greater understanding of many aspects of healthcare in the longer term. As this data is collected anonymously and has no impact on any aspect of patient care there are no risks or benefits to any of the individual patients from whom the data is collected.

Where is the study run from?
The study is run from NHS Blood and Transplant Clinical Trials Unit, Oxford (UK).

When is the study starting and how long is it expected to run for?
The study started in June 2011 and will run until May 2015.

Who is funding the study?
NHS Blood and Transplant (UK).

Who is the main contact?
Dr Lise J Estcourt
lise.estcourt@nhsbt.nhs.uk

Trial website

http://hospital.blood.co.uk/research/incite_study/index.asp

Contact information

Type

Scientific

Primary contact

Dr Lise Estcourt

ORCID ID

Contact details

NHS Blood and Transplant
Level 2
John Radcliffe Hospital
Headley Way
Headington
Oxford
OX3 9BQ
United Kingdom
lise.estcourt@nhsbt.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CTCP 10-02

Study information

Scientific title

Risk factors of intracranial haemorrhage in thrombocytopenic haematology patients: a case-control study

Acronym

INCITE

Study hypothesis

To advance the quality of care for haematology patients it is important to gain a greater understanding of the risk factors for life-threatening haemorrhage. This case-control study concentrates on intracranial haemorrhage because it is the most serious type of bleed caused by significant thrombocytopenia. If it does not cause death it may lead to significant long-term morbidity. However, this complication of thrombocytopenia is rare, its exact incidence is uncertain and pre-disposing risk factors are unknown.

As of 23/09/2013, the anticipated end date was changed from 01/05/2013 to 01/05/2015, and the trial is still actively recruiting patients.

Protocol can be found at: http://hospital.blood.co.uk/library/pdf/InCiTe_Study_Protocol.pdf

Ethics approval

Oxford REC B, 16/02/2011, ref: 10/H0605/78

Study design

Case control study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Intracranial haemorrhage in patients with haematological malignancies

Intervention

Case-control study with prospective active surveillance of cases

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Factors (e.g., age, type of haematological disease, treatment, infection) associated with an increased risk of developing an intracranial haemorrhage

Secondary outcome measures

1. Incidence of intracranial haemorrhage in thrombocytopenic haematology patients
2. Short-term outcomes for these patients (e.g., death or persistent neurological deficit)
3. Rates of death
4. Rates of significant neurological deficits

Overall trial start date

01/05/2011

Overall trial end date

01/05/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. All thrombocytopenic adult haematology patients in the UK undergoing intensive chemotherapy (defined as chemotherapy expected to cause a significant thrombocytopenia < 50 x 10E9/L for > 5 days) or a stem cell transplant who had an intracranial haemorrhage within the study period
2. Aged 16 years or older
3. Only patients being treated with curative intent
4. All severities of intracranial haemorrhage
5. All types of intracranial haemorrhage

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Dependent on true incidence of intracranial haemorrhage within the study population. Minimum of 78 cases and 78 controls. As of 23/09/2013, the trial is still actively recruiting patients.

Participant exclusion criteria

Does not meet the inclusion criteria

Recruitment start date

01/05/2011

Recruitment end date

01/05/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

NHS Blood and Transplant
Oxford
OX3 9BQ
United Kingdom

Sponsor information

Organisation

National Health Service Blood and Transplant (NHSBT) (UK)

Sponsor details

c/o Professor Marion Scott
NHS Blood and Transplant
Southmead Road
Bristol
BS10 5ND
United Kingdom

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

National Health Service Blood and Transplant (NHSBT) (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

Publication citations

Additional files

Editorial Notes