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 designCase control study
Primary study designObservational
Secondary study designCase-control study
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleRisk factors of intracranial haemorrhage in thrombocytopenic haematology patients: a case-control study
Study acronymINCITE
Study objectivesTo 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) studiedIntracranial haemorrhage in patients with haematological malignancies
InterventionCase-control study with prospective active surveillance of cases
Intervention typeOther
Primary outcome measureFactors (e.g., age, type of haematological disease, treatment, infection) associated with an increased risk of developing an intracranial haemorrhage
Secondary outcome measures1. 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 date01/05/2011
Completion date01/05/2015

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participantsDependent 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 criteria1. 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 criteriaDoes not meet the inclusion criteria
Date of first enrolment01/05/2011
Date of final enrolment01/05/2015

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 logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.