NCT06285656

Brief Summary

Postoperative bleeding is still an important concern after major abdominal surgery. Postoperative bleeding is the most important determinant of morbidity and death. It results in longer hospital stays, the necessity for extra radiological tests, interventional radiology treatments, and the possibility of reoperation. Early detection of postoperative bleeding reduces morbidity and mortality with appropriate intervention.Simultaneous arterial and venous blood gas measurements can be used to quickly identify the degree of bleeding and the need for replacement in serious trauma patients brought to the emergency room.Lactate levels, venous oxygen saturation, and the differential in partial pressure of carbon dioxide between arterial and venous blood can all be used to indicate the requirement for replacement, as demonstrated in several studies. The purpose of this study is to evaluate lactate levels, venous oxygen saturation, and arterial-venous partial pressure of carbon dioxide difference in blood gas analysis in order to assess the severity of bleeding in patients undergoing major abdominal surgery as early as possible and perform replacement as soon as possible.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2024

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 29, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 3, 2024

Completed
Last Updated

February 29, 2024

Status Verified

February 1, 2024

Enrollment Period

7 months

First QC Date

February 23, 2024

Last Update Submit

February 23, 2024

Conditions

Keywords

Abdominal SurgeryPostoperative HemorrhageBlood Transfusion

Outcome Measures

Primary Outcomes (1)

  • Eritrocyte replacement

    could we predict eritrocyte replacement at early postoperative period?

    6 months

Secondary Outcomes (1)

  • Postoperative Hemmorhagea

    6 months

Study Arms (2)

Group 1/

Patients with postoperative hemmorhagia

Grup 2

Patients without postoperative hemmorhagia

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients will have surgery at Ankara Bilkent City Hospital's General Surgery Clinic and then be transferred to the critical care unit.

You may qualify if:

  • Patients with major abdominal surgery
  • Postoperative intensive care unit following
  • Accepting to participate in research

You may not qualify if:

  • Age under 18 years old
  • Pregnant patients
  • Do not accept to participate of study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood gas

MeSH Terms

Conditions

Postoperative Hemorrhage

Condition Hierarchy (Ancestors)

HemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsPostoperative Complications

Central Study Contacts

Hüseyin Fahri Martlı

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2024

First Posted

February 29, 2024

Study Start

March 1, 2024

Primary Completion

October 1, 2024

Study Completion

October 3, 2024

Last Updated

February 29, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

IPD will not share other researchers.