Guideline Adherence for Preoperative Anemia Management in a PAC

Sponsor
Siriraj Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05447442
Collaborator
(none)
93
1
32
2.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    93 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Adherence to the Hospital Guideline for Evaluation and Management of Preoperative Anemia in Preanesthesia Assessment Center (SIPAC), Siriraj Hospital
    Anticipated Study Start Date :
    Oct 1, 2022
    Anticipated Primary Completion Date :
    Dec 1, 2023
    Anticipated Study Completion Date :
    Jun 1, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    Study group

    Patients with anemia will be checked whether they would be assessed by protocol.

    Outcome Measures

    Primary Outcome Measures

    1. Protocol adherence [Through study completion, an average of 1 month]

      The trial monitors adherence to the protocol (yes/no).

    Secondary Outcome Measures

    1. Perioperative transfusion [1 month after surgery]

      Transfusion during perioperative period

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Inclusion Criteria Patients who attend a preanesthesia clinic and have anemia.

    Anemia defined as

    1. Patients, with chronic kidney disease (CKD) stage 3+ or hematologic disease, have a hemoglobin level less than 10 g/dL; or

    2. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Siriraj hospital Bangkok Thailand 10700

    Sponsors and Collaborators

    • Siriraj Hospital

    Investigators

    • Principal Investigator: Mingkwan Wongyingsinn, Faculty of Medicine Siriraj Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mingkwan Wongyingsinn, MD, Principal Investigator, Siriraj Hospital
    ClinicalTrials.gov Identifier:
    NCT05447442
    Other Study ID Numbers:
    • 273/2565
    First Posted:
    Jul 7, 2022
    Last Update Posted:
    Jul 19, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 19, 2022