AzTrials
AzTrials

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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

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.

Thailand1 site
  • Siriraj hospital

    Bangkok, Bangkok, 10700

Other trials in Thailand

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.

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 groups in NCT05430659
Study groupRoleWhat they receive
EBL equal or more than 500 mlThe intraoperative estimated blood loss equal or more than 500 ml
Receives: Other: observational study
EBL less than 500 mlThe 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.

  1. 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)
  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.

  1. First posted24 Jun 2022
  2. Study start1 Jul 2022
  3. Primary completionNov 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

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)
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

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in