Intracranial haemorrhage in thrombocytopenic haematology patients
ISRCTN | ISRCTN05026912 |
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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
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
Contact information
Scientific
NHS Blood and Transplant
Level 2
John Radcliffe Hospital
Headley Way
Headington
Oxford
OX3 9BQ
United Kingdom
lise.estcourt@nhsbt.nhs.uk |
Study information
Study design | Case control study |
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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 |
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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
OX3 9BQ
United Kingdom
Sponsor information
Government
c/o Professor Marion Scott
NHS Blood and Transplant
Southmead Road
Bristol
BS10 5ND
United Kingdom
https://ror.org/0227qpa16 |
Funders
Funder type
Government
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.