Hematological DiseasesNCT06113601
Assessment of Admission to the ICU of Onco-hematological Patients.
An observational study of Hematological Diseases and Critical Illness, run by University Hospital A Coruña.
Trial summary
Multicenter, observational and prospective study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematological Diseases, Critical Illness
- How many people
- 800 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 1 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with a diagnosis of solid organ or hematological tumor who are admitted to the hospital and require ICU evaluation.
Who may be able to join
- Adults
- Solid organ tumor or hematological malignancy,
Who cannot join
- -under 18 years old
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Assessment of Admission to the ICU of Onco-hematological Patients. Income Patterns and Results.
Multicenter, observational and prospective study.
Read the detailed description
The data collection period will include 6 consecutive months, starting from the date of acceptance or conformity of the CEIC. Or, until an adequate sample size is reached that guarantees the statistical relevance of said analysis. All patients will subsequently be followed up 3 months after discharge from the ICU.
- Conditions
- Hematological Diseases, Critical Illness
- Being tested
- There is no intervention.
- Medical subject headings
- Hematologic Diseases, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There is no intervention.Other
There is no intervention in the study.
| Study group | Role | What they receive |
|---|---|---|
| Patients admitted to the ICU. | Not described Receives: Other: There is no intervention. | |
| Patients who are not admitted to the ICU. | Not described Receives: Other: There is no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital mortality.
Measured: During the 6 months of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start1 Jan 2024 (estimated)
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematological DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital A Coruña
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Cuenca Fito, University Hospital A Coruña
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06113601
- Sponsor's protocol ID
- 23772377
- Status last verified
- Oct 2023
- First submitted
- 11 Jul 2023
- Last updated
- 2 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Admission to the ICU of Onco-hematological Patients. Income Patterns and Results.
- ClinicalTrials.gov ID
- NCT06113601
- Acronym / sponsor ID
- 23772377
- Conditions
- Hematological Diseases, Critical Illness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University Hospital A CoruñaUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 2 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multicenter, observational and prospective study.
Detailed description
The data collection period will include 6 consecutive months, starting from the date of acceptance or conformity of the CEIC. Or, until an adequate sample size is reached that guarantees the statistical relevance of said analysis. All patients will subsequently be followed up 3 months after discharge from the ICU.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients admitted to the ICU. | – | Other: There is no intervention. |
| Patients who are not admitted to the ICU. | – | Other: There is no intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with a diagnosis of solid organ or hematological tumor who are admitted to the hospital and require ICU evaluation.
Key inclusion criteria (2 listed)
- Adults
- Solid organ tumor or hematological malignancy,
Key exclusion criteria (1 listed)
- -under 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| There is no intervention.There is no intervention in the study. | Other | Patients admitted to the ICU., Patients who are not admitted to the ICU. |
Primary outcome
Hospital mortality.
Time frame: During the 6 months of the study.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematological Diseases and Critical Illness, run by University Hospital A Coruña.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elena Cuenca Fito (647113703, ecuencafito@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital mortality. (time frame: During the 6 months of the study.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2023.