Intracranial haemorrhage in thrombocytopenic haematology patients

ISRCTN	ISRCTN05026912
DOI	https://doi.org/10.1186/ISRCTN05026912
Secondary identifying numbers	CTCP 10-02

Submission date: 11/03/2011
Registration date: 17/06/2011
Last edited: 24/07/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Haematological Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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. It is not known 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.

Who can participate?
Patients aged 16 or over 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

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. Information is collected 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?
NHS Blood and Transplant Clinical Trials Unit, Oxford (UK)

When is the study starting and how long is it expected to run for?
June 2011 to 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

Study website

Contact information

Dr Lise Estcourt
Scientific

NHS Blood and Transplant
Level 2
John Radcliffe Hospital
Headley Way
Headington
Oxford
OX3 9BQ
United Kingdom

Email	lise.estcourt@nhsbt.nhs.uk

Study information

Study design	Case control study
Primary study design	Observational
Secondary study design	Case-control study
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Risk factors of intracranial haemorrhage in thrombocytopenic haematology patients: a case-control study
Study acronym	INCITE
Study objectives	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. Protocol can be found at: http://hospital.blood.co.uk/library/pdf/InCiTe_Study_Protocol.pdf
Ethics approval(s)	Oxford REC B, 16/02/2011, ref: 10/H0605/78
Health condition(s) or problem(s) studied	Intracranial haemorrhage in patients with haematological malignancies
Intervention	Case-control study with prospective active surveillance of cases
Intervention type	Other
Primary outcome measure	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 study start date	01/05/2011
Completion date	01/05/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	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.
Key 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
Key exclusion criteria	Does not meet the inclusion criteria
Date of first enrolment	01/05/2011
Date of final enrolment	01/05/2015

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

John Radcliffe Hospital

Oxford
OX3 9BQ
United Kingdom

Sponsor information

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

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

"ROR"	https://ror.org/0227qpa16

Funders

Funder type

Government

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	07/02/2014		Yes	No

Editorial Notes

24/07/2020: No publications found.
09/08/2017: Publication reference added.
23/09/2013: The overall trial end date was changed from 01/05/2013 to 01/05/2015.