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
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