Condition category
Haematological Disorders
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status
Results overdue

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. 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

Trial website

Contact information



Primary contact

Dr Lise Estcourt


Contact details

NHS Blood and Transplant
Level 2
John Radcliffe Hospital
Headley Way
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number

CTCP 10-02

Study information

Scientific title

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



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.

Protocol can be found at:

Ethics approval

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

Study design

Case control study

Primary study design


Secondary study design

Case-control study

Trial setting


Trial type


Patient information sheet

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


Intracranial haemorrhage in patients with haematological malignancies


Case-control study with prospective active surveillance of cases

Intervention type



Not Applicable

Drug names

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 trial start date


Overall trial end date


Reason abandoned (if study stopped)


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


Age group




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


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

John Radcliffe Hospital
United Kingdom

Sponsor information


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

Sponsor details

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

Sponsor type




Funder type


Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Basic results (scientific)

Publication list

2014 protocol in:

Publication citations

Additional files

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.