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
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
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