General SurgeryNCT05430659
Intraoperative Estimated Blood Loss, Blood Transfusion, and Postoperative Clinical Outcomes in Patients Undergoing Non Cardiac Surgery, Siriraj Hospital
An observational study of General Surgery and Blood Loss, Surgical, run by Siriraj Hospital at 1 site in Thailand.
Trial summary
After review literature, Siriraj hospital has not unanimous protocol to guide proper preoperative anemia and blood transfusion. This retrospective study will review non-cardiac surgery cases and collect data such as demographic data, surgical procedures, anesthetic techniques, preoperative hemoglobin level… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- General Surgery, Blood Loss, Surgical
- What is being tested?
- observational study
- How many people
- 1,268 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jul 2022to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing surgical procedures consist of head/neck surgery, general surgery, urologic surgery, vascular surgery, neurologic surgery, orthopedic surgery, otolaryngologic surgery and gynecologic surgery.
Who may be able to join
- Patients undergoing surgical procedures consist of head/neck surgery, general surgery, urologic surgery, vascular surgery, neurologic surgery, orthopedic surgery, otolaryngologic surgery and gynecologic surgery.
Who cannot join
- Patients don't have target data or losing of interesting document.
Trial locations and contacts
1 site in 1 country.
About this study
After review literature, Siriraj hospital has not unanimous protocol to guide proper preoperative anemia and blood transfusion. This retrospective study will review non-cardiac surgery cases and collect data such as demographic data, surgical procedures, anesthetic techniques, preoperative hemoglobin level, intraoperative estimate blood loss, blood transfusion, and post operative complication in Siriraj hospital which has many patients undergo various operations. This study can be model to develop preoperative anemia management guideline in Siriraj Preanesthesia Assessment Center (SIPAC), Siriraj hospital and reduce risk and adverse outcomes after blood transfusion in the future.
Read the detailed description
One of the worldwide health problems that covers more than a quarter of the population is anemia. The World Health Organization (WHO) recommendations use of hemoglobin concentration for diagnosing anemia as hemoglobin (Hb) level <12 g/dL and < 13 g/dL for women and men, respectively. The most of anemic patients caused by iron deficiency anemia (IDA), followed by the anemia of chronic disease (ACD).
Iron deficiency anemia often result from malnutrition status, acute or chronic blood loss such as perioperative blood loss. Chronic kidney disease is the primary cause of anemia of chronic disease, followed by acute or chronic inflammatory conditions, or in patients with malignancies.Currently, there are lack of preoperative evaluation, diagnostic methods, and adequate treatments for anemia before attaining elective non cardiac surgery. Baron et al retrospective study the European Surgical Outcome included 39,309 patients from 28 European countries. The prevalence of anemic patients was about 26.5% in women and 31.1% in men. The higher rate of prolonged hospital administration (P = .0001) and transferred to intensive care unit (P = .001) in moderate to severe anemic patients. Moreover, anemic patients who undergone cardiac surgery and non-cardiac surgery showed a higher mortality than nonanemic patients.
Preoperative hemoglobin level was used with other factors such as demographic data, surgical procedures, and anesthetic technique to increase predictive accuracy of perioperative blood transfusion. The mortality rate raised in anemic patients who received blood transfusion in perioperative period. Criteria for blood transfusion had various factors. The important factor which usually used is hemoglobin level: Liberal strategy suggested starting blood transfusion when Hb level below 9-10 g/dL, another method was Restrictive strategy that starting blood transfusion if Hb level below 7-8 g/dL. In addition, the hemoglobin threshold cut-off point level often differed due to the objective for each study.Althrough many organizations tried to develop standard protocol for blood transfusion, the universal transfusion threshold level cloud not properly use for all patients.Blood transfusion remained the cornerstone of the treatment of anemia but intraoperative period inappropriately transfused blood component causing risk of post operative complication, 30-days mortality, increasing length of hospital stay, and transferring to intensive care unit.
Moreover, The National Blood Authority studied about types of operation and operation at risk for blood transfusion that had operative time more than 2 hours and estimated blood loss more than 500 ml, needed to receive blood transfusion before surgery. The American College of Cardiology had found various factors affecting peri-operative blood transfusion risk but they were not practical to use in real-life practice.
After review literature, Siriraj hospital has not unanimous protocol to guide proper preoperative anemia and blood transfusion. This retrospective study will review non-cardiac surgery cases and collect data such as demographic data, surgical procedures, anesthetic techniques, preoperative hemoglobin level, intraoperative estimate blood loss, blood transfusion, and post operative complication in Siriraj hospital which has many patients undergo various operations. This study can be model to develop preoperative anemia management guideline in Siriraj Preanesthesia Assessment Center (SIPAC), Siriraj hospital and reduce risk and adverse outcomes after blood transfusion in the future.
- Conditions
- General Surgery, Blood Loss, Surgical
- Being tested
- observational study
- Medical subject headings
- Blood Loss, Surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational studyOther
Retrospective observational study
| Study group | Role | What they receive |
|---|---|---|
| EBL equal or more than 500 ml | The intraoperative estimated blood loss equal or more than 500 ml Receives: Other: observational study | |
| EBL less than 500 ml | The intraoperative estimated blood loss less than 500 ml Receives: Other: observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operation with intraoperative blood loss of more than 500 ml
Operation with intraoperative blood loss of more than 500 ml
Measured: Day of surgery
Secondary outcomes (1)
Risks associated with intraoperative blood loss of more than 500 ml
Risks associated with intraoperative blood loss of more than 500 ml
Measured: Day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start1 Jul 2022
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General SurgeryStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 1,268 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Siriraj Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mingkwan Wongyingsinn, MD, Siriraj Hospital
- Investigators
- Mingkwan Wongyingsinn, Principal investigator, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05430659
- Sponsor's protocol ID
- 333/2565
- Status last verified
- Jun 2025
- First submitted
- 15 Jun 2022
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- 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 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Estimated Blood Loss, Blood Transfusion, and Postoperative Clinical Outcomes in Patients Undergoing Non Cardiac Surgery, Siriraj Hospital
- ClinicalTrials.gov ID
- NCT05430659
- Acronym / sponsor ID
- 333/2565
- Conditions
- General Surgery, Blood Loss, Surgical
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,268 participants (estimated)
- Lead sponsor
- Siriraj HospitalUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 24 Jun 2022 (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.
After review literature, Siriraj hospital has not unanimous protocol to guide proper preoperative anemia and blood transfusion. This retrospective study will review non-cardiac surgery cases and collect data such as demographic data, surgical procedures, anesthetic techniques, preoperative hemoglobin level, intraoperative estimate blood loss, blood transfusion, and post operative complication in Siriraj hospital which has many patients undergo various operations. This study can be model to develop preoperative anemia management guideline in Siriraj Preanesthesia Assessment Center (SIPAC), Siriraj hospital and reduce risk and adverse outcomes after blood transfusion in the future.
Detailed description
One of the worldwide health problems that covers more than a quarter of the population is anemia. The World Health Organization (WHO) recommendations use of hemoglobin concentration for diagnosing anemia as hemoglobin (Hb) level <12 g/dL and < 13 g/dL for women and men, respectively. The most of anemic patients caused by iron deficiency anemia (IDA), followed by the anemia of chronic disease (ACD).
Iron deficiency anemia often result from malnutrition status, acute or chronic blood loss such as perioperative blood loss. Chronic kidney disease is the primary cause of anemia of chronic disease, followed by acute or chronic inflammatory conditions, or in patients with malignancies.Currently, there are lack of preoperative evaluation, diagnostic methods, and adequate treatments for anemia before attaining elective non cardiac surgery. Baron et al retrospective study the European Surgical Outcome included 39,309 patients from 28 European countries. The prevalence of anemic patients was about 26.5% in women and 31.1% in men. The higher rate of prolonged hospital administration (P = .0001) and transferred to intensive care unit (P = .001) in moderate to severe anemic patients. Moreover, anemic patients who undergone cardiac surgery and non-cardiac surgery showed a higher mortality than nonanemic patients.
Preoperative hemoglobin level was used with other factors such as demographic data, surgical procedures, and anesthetic technique to increase predictive accuracy of perioperative blood transfusion. The mortality rate raised in anemic patients who received blood transfusion in perioperative period. Criteria for blood transfusion had various factors. The important factor which usually used is hemoglobin level: Liberal strategy suggested starting blood transfusion when Hb level below 9-10 g/dL, another method was Restrictive strategy that starting blood transfusion if Hb level below 7-8 g/dL. In addition, the hemoglobin threshold cut-off point level often differed due to the objective for each study.Althrough many organizations tried to develop standard protocol for blood transfusion, the universal transfusion threshold level cloud not properly use for all patients.Blood transfusion remained the cornerstone of the treatment of anemia but intraoperative period inappropriately transfused blood component causing risk of post operative complication, 30-days mortality, increasing length of hospital stay, and transferring to intensive care unit.
Moreover, The National Blood Authority studied about types of operation and operation at risk for blood transfusion that had operative time more than 2 hours and estimated blood loss more than 500 ml, needed to receive blood transfusion before surgery. The American College of Cardiology had found various factors affecting peri-operative blood transfusion risk but they were not practical to use in real-life practice.
After review literature, Siriraj hospital has not unanimous protocol to guide proper preoperative anemia and blood transfusion. This retrospective study will review non-cardiac surgery cases and collect data such as demographic data, surgical procedures, anesthetic techniques, preoperative hemoglobin level, intraoperative estimate blood loss, blood transfusion, and post operative complication in Siriraj hospital which has many patients undergo various operations. This study can be model to develop preoperative anemia management guideline in Siriraj Preanesthesia Assessment Center (SIPAC), Siriraj hospital and reduce risk and adverse outcomes after blood transfusion in the future.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EBL equal or more than 500 ml | – | Other: observational studyThe intraoperative estimated blood loss equal or more than 500 ml |
| EBL less than 500 ml | – | Other: observational studyThe intraoperative estimated blood loss less than 500 ml |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing surgical procedures consist of head/neck surgery, general surgery, urologic surgery, vascular surgery, neurologic surgery, orthopedic surgery, otolaryngologic surgery and gynecologic surgery.
Key inclusion criteria (1 listed)
- Patients undergoing surgical procedures consist of head/neck surgery, general surgery, urologic surgery, vascular surgery, neurologic surgery, orthopedic surgery, otolaryngologic surgery and gynecologic surgery.
Key exclusion criteria (1 listed)
- Patients don't have target data or losing of interesting document.
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 |
|---|---|---|
| observational studyRetrospective observational study | Other | EBL equal or more than 500 ml, EBL less than 500 ml |
Primary outcome
Operation with intraoperative blood loss of more than 500 ml
Time frame: Day of surgery
Operation with intraoperative blood loss of more than 500 ml
1 secondary outcome
Risks associated with intraoperative blood loss of more than 500 ml
Time frame: Day of surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: Undecided
Related trials for General Surgery
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
Not yet recruiting
Augmented-Reality ICG Fluorescence Second-Look for Residual Nodal Disease After Axillary Dissection in Breast Cancer
Breast Cancer, Breast Neoplasms
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
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.
Mingkwan Wongyingsinn principal investigator
Siriraj Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of General Surgery and Blood Loss, Surgical, run by Siriraj Hospital at 1 site in Thailand.
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 1 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: under way, not looking for participants, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operation with intraoperative blood loss of more than 500 ml (time frame: Day of surgery). 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 6 Mar 2026.