- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05447442
Guideline Adherence for Preoperative Anemia Management in a PAC
Adherence to the Hospital Guideline for Evaluation and Management of Preoperative Anemia in Preanesthesia Assessment Center (SIPAC), Siriraj Hospital
Anemia in surgical patients is a common seriously problem; around 40 % of patients presenting for major surgery are anemic problem. Patients with major surgery have significantly higher rates of acute blood loss. Whereas , patients with pre-operative anemia prone to be transfused blood component in pre-operative or intraoperative and postoperative periods that associated with worse outcomes , prolonged hospital stays , increased risk of morbidity and mortality . Therefore, patients undergoing major surgery should be optimization for pre-operative anemia.
In November 2021, Siriraj Preanesthesia Assessment Center (SIPAC) has developed and implemented a preoperative anemia management guideline which is one pillar of perioperative patient blood management. The objective of this guideline is to optimize red blood cell mass before patients having operation. The investigators are realize the important of pre-operative anemia of patients who undergoing elective surgery. The investigators will aim to evaluate adherence to the preoperative anemia management guideline protocol and perioperative outcomes and use the data of this study to setting guidelines for preoperative anemia evaluation and management in SIPAC of department of anesthesiology in Siriraj hospital for improving workflow and optimization before elective surgery, supporting to a reduction in blood transfusion, hospital stay, morbidity and health care costs of public health of Thailand.
Study Overview
Status
Conditions
Detailed Description
From World Health Organization (WHO) criteria for diagnosing anemia is hemoglobin level lower than 12 g/dL for women and hemoglobin level lower than 13 g/dL for men. The most of anemic patients caused by Iron deficiency anemia and chronic disease.
From frank S Hong that study about of prevalence and causes of preoperative anemia in elective major surgery show that preoperative anemia affects 13.9% of patients undergoing elective surgery. The most common is iron deficiency anemia 27.4%. Other common causes of anemia including underlying malignancy 18.3 %, end stage renal disease 11.5 % and other chronic disease 7.2%.
At present, there are several study about efficiency of iron therapy in pre-operative anemia that shown an increase in hemoglobin and a decrease in red cell transfusion when treated with iron therapy in 4-6 weeks. Detection of preoperative anemia should be optimized and evaluated as soon as possible at least 14 days before elective surgery.
Musallam et al. studied the prevalence and outcomes of anemia in the dataset of the American College of surgeons' National Surgical Quality Improvement Program show that anemic patients undergoing cardiac surgery & non-cardiac surgery present a higher mortality, prolonged hospital stay and more intensive care admission compared with patient non-anemic patients.
In November 2021, Siriraj Preanesthesia Assessment Center (SIPAC) has developed and implemented a preoperative anemia management guideline which is one pillar of perioperative patient blood management. The objective of this guideline is to optimize red blood cell mass before patients having operation. The investigators are realize the important of pre-operative anemia of patients who undergoing elective surgery. The investigators will aim to evaluate adherence to the preoperative anemia management guideline protocol and perioperative outcomes and use the data of this study to setting guidelines for preoperative anemia evaluation and management in SIPAC of department of anesthesiology in Siriraj hospital for improving workflow and optimization before elective surgery, supporting to a reduction in blood transfusion, hospital stay, morbidity and health care costs of public health of Thailand.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Mingkwan Wongyingsinn, MD
- Phone Number: 024197995
- Email: mingkwan.won@mahidol.ac.th
Study Contact Backup
- Name: Mingkwan Wongyingsinn
- Phone Number: 024197995
- Email: mingkwan.won@mahidol.ac.th
Study Locations
-
-
-
Bangkok, Thailand, 10700
- Recruiting
- Siriraj Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria Patients who attend a preanesthesia clinic and have anemia.
Anemia defined as
- Patients, with chronic kidney disease (CKD) stage 3+ or hematologic disease, have a hemoglobin level less than 10 g/dL; or
- Patients other than No. 1 and have hemoglobin level less than 13 g/dL in men or a hemoglobin level less than 12 g/dL in women.
Exclusion Criteria:
- none
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Study group
Patients with anemia will be checked whether they would be assessed by protocol.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Protocol adherence
Time Frame: Through study completion, an average of 1 month
|
The trial monitors adherence to the protocol (yes/no).
|
Through study completion, an average of 1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perioperative transfusion
Time Frame: 1 month after surgery
|
Transfusion during perioperative period
|
1 month after surgery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 273/2565
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anemia
-
SanofiActive, not recruitingWarm Autoimmune Hemolytic Anemia (wAIHA)United States, Austria, China, Denmark, Germany, Hungary, Italy, Spain, United Kingdom
-
SanofiTerminatedWarm Autoimmune Hemolytic Anemia (wAIHA)United Kingdom, Belgium, Netherlands, France, United States, Germany, Hungary, Italy
-
Hospital Universitario Dr. Jose E. GonzalezCompletedPernicious Anemia | Megaloblastic Anemia NosMexico
-
Assistance Publique - Hôpitaux de ParisNot yet recruitingSevere Aplastic Anemia | Idiopathic Aplastic Anemia | Moderate Aplastic Anemia Requiring Transfusions
-
Abdelwahed, Mai Mahmoud Mohamed, M.D.UnknownAnemia During PregnancyEgypt
-
University of California, DavisInstituto Mexicano del Seguro Social; Thrasher Research Fund; Mexican National... and other collaboratorsCompleted
-
Incyte CorporationActive, not recruitingWarm Autoimmune Hemolytic Anemia (wAIHA)Spain, United States, Austria, Belgium, Canada, France, Germany, Israel, Italy, Japan, Netherlands, Poland, United Kingdom
-
Cornell UniversityUniversity of California, Los AngelesCompletedPregnancy Anemia | Newborn; AnemiaUnited States
-
Peking Union Medical College HospitalRecruiting