Blood Characteristics and Abdominal Emergency Surgery | NCT06028854

Studies
Blood Characteristics and Abdominal Emergency Surgery

NCT06028854

Sponsor

University of Chile

Status

Suspended

Last Update Posted

Dec 30, 2024Actual

Enrollment

40Estimated

Phase

Not provided

Conditions

Surgical Wound

Interventions

Not provided

Countries

Chile

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

Dec 2024

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The study was suspended because of difficulties in recruiting participants within the expected timeframe.

Expanded Access Info

Start Date

Oct 15, 2025Estimated

Primary Completion Date

Oct 15, 2027Estimated

Completion Date

Dec 15, 2027Estimated

First Submitted Date

Aug 31, 2023

First Submission Date that Met QC Criteria

Sep 7, 2023

First Posted Date

Sep 8, 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

Dec 26, 2024

Last Update Posted Date

Dec 30, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

After surgical tissue damage, cellular blood components are involved in tissue repair processes, yet their preoperative characteristics are not considered in routine clinical practice.

Detailed Description

Surgical injuries initiate the recruitment of cellular blood components for tissue repair. Baseline inflammation levels and cellular response to tissue damage are absent from perioperative management algorithms despite their importance in regeneration. This project seeks to examine patients preoperative parameters before surgery and evaluate if there is a correlation with clinical outcomes.

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

Retention

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
High Neutrophil count		Patients with high neutrophil count in their preoperative complete blood count
Low Neutrophil count		Patients with low neutrophil count in their preoperative complete blood count

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Death	The number of deceased patients.	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients between 18 and 65 years of age at surgery.
Patients with acute intra-abdominal pathology requiring emergency surgery.
A complete blood count was performed in the emergency department of our center within 24 hours before surgery.

Exclusion Criteria:

Patients who are users of anticoagulation before admission for any reason
Patients who have had previous hospitalization or surgery in the last 6 months.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with acute intrabdominal pathology who requires surgery in the next 24 hours.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Felipe Maldonado	Hospital Clinico de la Universidad de Chile	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Clínico de la Universidad de Chile		Independencia	Santiago Metropolitan	8380456	Chile
Hospital Clínico Universidad de Chile

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000072836	Surgical Wound

Ancestor Terms

ID	Term
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided