Postoperative HemorrhageNCT06285656
Femoral Blood Gas and Prediction of Postoperative Bleeding
An observational study of Postoperative Hemorrhage and Blood Transfusion, run by Ankara City Hospital Bilkent.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Hemorrhage, Blood Transfusion
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 3 Oct 2024
- How long will I take part?
- 3 Days
- 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 will have surgery at Ankara Bilkent City Hospital's General Surgery Clinic and then be transferred to the critical care unit.
Who may be able to join
- Patients with major abdominal surgery
- Postoperative intensive care unit following
- Accepting to participate in research
Who cannot join
- Age under 18 years old
- Pregnant patients
- Do not accept to participate of study
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Can Femoral Blood Gas Analysis Predict Early Bleeding and the Need for Blood Products After Abdominal Major Surgery: a Prospective Observational Study.
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.
- Conditions
- Postoperative Hemorrhage, Blood Transfusion
- Keywords
- Abdominal Surgery, Postoperative Hemorrhage, Blood Transfusion
- Medical subject headings
- Postoperative Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1/ | Patients with postoperative hemmorhagia | |
| Grup 2 | Patients without postoperative hemmorhagia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eritrocyte replacement
could we predict eritrocyte replacement at early postoperative period?
Measured: 6 months
Secondary outcomes (1)
Postoperative Hemmorhagea
Could we predict postoperative hemorrhage in the early postoperative period?
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start1 Mar 2024 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion3 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative HemorrhageStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- 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
- 100 participants (estimated)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06285656
- Sponsor's protocol ID
- ASH-KG
- Status last verified
- Feb 2024
- First submitted
- 23 Feb 2024
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not share other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Femoral Blood Gas Analysis Predict Early Bleeding and the Need for Blood Products After Abdominal Major Surgery: a Prospective Observational Study.
- ClinicalTrials.gov ID
- NCT06285656
- Acronym / sponsor ID
- ASH-KG
- Conditions
- Postoperative Hemorrhage, Blood Transfusion
- Keywords
- Abdominal Surgery, Postoperative Hemorrhage, Blood Transfusion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 3 Oct 2024 (estimated)
- First posted
- 29 Feb 2024 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1/ | – | –Patients with postoperative hemmorhagia |
| Grup 2 | – | –Patients without postoperative hemmorhagia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients will have surgery at Ankara Bilkent City Hospital's General Surgery Clinic and then be transferred to the critical care unit.
Key inclusion criteria (3 listed)
- Patients with major abdominal surgery
- Postoperative intensive care unit following
- Accepting to participate in research
Key exclusion criteria (3 listed)
- Age under 18 years old
- Pregnant patients
- Do not accept to participate of study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Eritrocyte replacement
Time frame: 6 months
could we predict eritrocyte replacement at early postoperative period?
1 secondary outcome
Postoperative Hemmorhagea
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Femoral blood gas analysis, another tool to assess hemorrhage severity following trauma: an exploratory prospective studyLink provided by the sponsor.
- Prognostic Significance of Blood Lactate and Lactate Clearance in Trauma PatientsLink provided by the sponsor.
- Changes in central venous saturation after major surgery, and association with outcomeLink provided by the sponsor.
- Individual participant dataSharing planned: No. IPD will not share other researchers.
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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 Postoperative Hemorrhage and Blood Transfusion, run by Ankara City Hospital Bilkent.
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 3 inclusion and 3 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 29 Feb 2024. 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 Hüseyin Fahri Martlı (+905301794699, fahri_martli@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eritrocyte replacement (time frame: 6 months). 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 29 Feb 2024; AzTrials last refreshed its copy on 8 Nov 2026.