Assessment of Admission to the ICU of Onco-hematological... | NCT06113601

Studies
Assessment of Admission to the ICU of Onco-hematological Patients.

NCT06113601

Sponsor

University Hospital A Coruña

Status

Unknown status

Last Update Posted

Nov 2, 2023Actual

Enrollment

800Estimated

Phase

Not provided

Conditions

Hematological Diseases
Critical Illness

Interventions

There is no intervention.

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2024Estimated

Primary Completion Date

Jul 1, 2024Estimated

Completion Date

Sep 1, 2024Estimated

First Submitted Date

Jul 11, 2023

First Submission Date that Met QC Criteria

Nov 1, 2023

First Posted Date

Nov 2, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 1, 2023

Last Update Posted Date

Nov 2, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Elena Cuenca Fito, Principal Investigator, University Hospital A CoruñaPrincipal Investigator

Lead Sponsor

University Hospital A CoruñaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

800Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients admitted to the ICU.			Other: There is no intervention.
Patients who are not admitted to the ICU.			Other: There is no intervention.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
There is no intervention.	Other	There is no intervention in the study.	Patients admitted to the ICU. Patients who are not admitted to the ICU.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hospital mortality.		During the 6 months of the study.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults
Solid organ tumor or hematological malignancy,

Exclusion Criteria:

-under 18 years old

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with a diagnosis of solid organ or hematological tumor who are admitted to the hospital and require ICU evaluation.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Elena Cuenca Fito	Contact	647113703		ecuencafito@gmail.com

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006402	Hematologic Diseases
D016638	Critical Illness

Ancestor Terms

ID	Term
D006425	Hemic and Lymphatic Diseases
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided