Preoperative Anaemia prevaLence In surgiCal patiEnts | NCT03978260

Studies
Preoperative Anaemia prevaLence In surgiCal patiEnts

NCT03978260

Sponsor

Johann Wolfgang Goethe University Hospital

Status

Completed

Last Update Posted

Aug 7, 2025Actual

Enrollment

2,500Actual

Phase

Not provided

Conditions

Anemia
Iron-deficiency
Folic Acid Deficiency
Vitamin B 12 Deficiency
Anaemia of Renal Disease
Anemia of Chronic Inflammation

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 15, 2019Actual

Primary Completion Date

Dec 30, 2022Actual

Completion Date

Dec 31, 2023Actual

First Submitted Date

May 23, 2019

First Submission Date that Met QC Criteria

Jun 4, 2019

First Posted Date

Jun 7, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 3, 2025

Last Update Posted Date

Aug 7, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Patrick Meybohm, M.D., Principal Investigator, Wuerzburg University HospitalPrincipal Investigator

Lead Sponsor

Johann Wolfgang Goethe University HospitalOTHER

Collaborators

Name	Class
Medical University of Vienna	OTHER
University Hospital, Angers	OTHER_GOV
Medical University of Graz	OTHER
Hospital del Mar

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Preoperative anaemia is common in surgery, with a prevalence between 10 and 50 %, and is an independent risk factor for morbidity and mortality.

Anaemia is mostly the result of an inadequate erythropoiesis due to iron deficiency, lack of vitamin B12 or folate, and bone marrow diseases. Among the elderly, renal disease and chronic inflammation account for approximately one-third of all anaemia incidences. The aim of this study is to provide detailed data about the prevalence of preoperative deficiencies in iron, vitamin B12 and/or folate and the presence of underlying renal or chronic diseases in patients undergoing major surgery.

Detailed Description

Preoperative anaemia is common in surgery, with a prevalence between 10 and 50 %, and is an independent risk factor for morbidity and mortality. Due to the potential risk of additional blood loss, anaemia represents a serious disease condition within the surgical field. Especially patients undergoing major elective surgery are at risk of substantial blood loss. Anaemia is mostly the result of an inadequate erythropoiesis due to iron deficiency, lack of vitamin B12 or folate, and bone marrow diseases. Among the elderly, renal disease and chronic inflammation account for approximately one-third of all anaemia incidences. The aim of this study is to provide detailed data about the prevalence of preoperative deficiencies in iron, vitamin B12 and/or folate and the presence of underlying renal or chronic diseases in patients undergoing major surgery. Results will facilitate design of supplementation strategies to improve haemoglobin level before surgery.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,500Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prevalence of preoperative anaemia	Hemoglobin level	prior surgery

Secondary Outcomes

Measure	Description	Time Frame
Number of patients with red blood cell transfusion	Amount of transfused units per patient	30 day
Number of patient with revision	Number of patients with Revision after surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥ 18 years
Written informed consent prior to study participating according to the national law requirements
Patients undergoing major surgery
Expected hospital stay with a minimum of 24 hours

Exclusion Criteria:

Preoperative autologous blood donation
Patients with expected re-surgery within the planned 7-day recruitment period

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Major surgical patients

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Johann Wolfgang Goethe University Hospital		Frankfurt am Main	Hesse	60590	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41240945	Derived	Choorapoikayil S, Baron DM, Spahn DR, Lasocki S, Boryshchuk D, Yeghiazaryan L, Posch M, Bisbe E, Metnitz P, Reichmayr M, Zacharowski K, Meybohm P; German Society of Anaesthesiology and Intensive Care (GSAIC) Trials Group; SFAR research network; Supportive Anaesthesia Trainee-led Audit and Research Network (SATURN); ALICE study collaborators. The aetiology and prevalence of preoperative anaemia in patients undergoing major surgery (ALICE): an international, prospective, observational cohort study. Lancet Glob Health. 2025 Dec;13(12):e2041-e2050. doi: 10.1016/S2214-109X(25)00320-1.

ID	Term
D000740	Anemia
D018798	Anemia, Iron-Deficiency
D005494	Folic Acid Deficiency
D014806	Vitamin B 12 Deficiency

ID	Term
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D000747	Anemia, Hypochromic
D000090463	Iron Deficiencies