Systematic Analysis of a Standardized Questionnaire to Detect Possible Bleeding Disorders and Its Impact on Perioperative Hemostasis Management

NCT ID: NCT04993170

Last Updated: 2025-02-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 5004 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-06-23
• Study Completion Date: 2024-06-01

Brief Summary

With the help of a standardized questionnaire, an increased risk of bleeding due to pre-existing hemostasis disorders in the site-specific patient population will be detected and the corresponding enhanced diagnostic measures will be initiated. The planned prospective observational study should i.) systematically investigate the results of this procedure and ii.) allow a comparison with a retrospective perioperative cohort that was cared for at the Benjamin Franklin Campus before the introduction of the questionnaire. Due to the campus structure with a large vascular surgery center as well as a large urological, general and trauma surgery department, a high number of multimorbid patients with pre-existing disorders of primary hemostasis, mainly caused by medication or secondary diseases, is to be expected.

In the following, the feasibility of the required measures in clinical routine (measured by the frequency of actual changes or modifications of the initially planned perioperative procedure, the adequate implementation of indicated diagnostic measures, etc.) will be examined.

Detailed Description

The aim of the study is the systematic scientific evaluation of a standardized questionnaire for bleeding history already used in clinical routine during the preoperative anesthesiological visit and its impact on perioperative coagulation management.

The routine use of a standardized questionnaire to assess bleeding risk is based on a study on the preoperative identification of patients with (primary) hemostasis disorders from 2007: in a patient collective of 5649 patients from different disciplines at the Charité - Universitätsmedizin Berlin, a positive predictive value of 99% for the presence of a hemostasis disorder could be established if at least four questions of a standardized bleeding history questionnaire were answered positively. This is not possible in the same way with the plasmatic coagulation-global tests established in clinical routine.

The standardized application of the questionnaire serves to identify patients at risk of bleeding at an early stage and to adapt and optimize perioperative coagulation management accordingly by initiating targeted diagnostics and therapy. However, a systematic scientific evaluation of this questionnaire with regard to the conditions at the Benjamin Franklin Campus with a large vascular surgery center as well as a large urological, general and trauma surgery department and a high number of multimorbid patients with pre-existing disorders of primary hemostasis, mainly caused by medication or secondary diseases, is still pending.

Conditions

Perioperative Hemorrhage; Hemostasis

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

Bleeding assessment tool

The standardized application of the questionnaire serves to identify patients at risk of bleeding at an early stage and to adapt and optimize perioperative coagulation management accordingly by initiating targeted diagnostics and therapy

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

All adult (age ≥ 18 years) patients of both genders undergoing elective surgery at the Benjamin Franklin campus in the 12-month period

Exclusion Criteria

• Pregnancy, lactation
• Patients not capable of giving consent
• Already diagnosed hemostasis disorder
• Patients under (plasmatic) anticoagulation

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute for biometry and clinical epidemiology, Charité University Berlin, Germany

UNKNOWN

Sponsor Role: collaborator

Institute for transfusion medicine, Charité University Berlin, Germany

UNKNOWN

Sponsor Role: collaborator

Einstein center digital future

UNKNOWN

Sponsor Role: collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Sascha Treskatsch

Univ.-Prof. Dr. med., Head of Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin

Berlin, State of Berlin, Germany

Countries

Germany

Other Identifiers

EA4/181/20

Identifier Type: -

Identifier Source: org_study_id