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

NCT04993170 | Completed DMC

• 1 other identifier: EA4/181/20
• Study Type: observational
• Target: 5,004
• Locations: 1 country
• Sites: 1

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.

Conditions

Perioperative Hemorrhage; Hemostasis

Outcome Measures

Primary Outcomes (1)

• Relative frequency of changes in the initially planned perioperative procedure

  The relative frequency of changes in the initially planned perioperative procedure in patients with abnormalities in the preoperative questionnaire and target-oriented laboratory diagnostics will be measured. Changes can be: * need for extended coagulation diagnostics * hemostaseological consultation preoperatively * administration of coagulation-active substances

  Perioperative period

Secondary Outcomes (2)

• Perioperative complications

  Perioperative period

• Diagnostic discrepancy

  Perioperative period

Interventions

Bleeding assessment tool DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All adult (age ≥ 18 years) patients of both sexes undergoing elective surgery at the Benjamin Franklin Campus in the period of 12 months and presenting at the anesthesiological preoperative assessment will be recorded. A historical cohort that received surgical care at the Benjamin Franklin campus prior to the introduction of the questionnaire (07/01/2018 - 06/30/2019) will serve as the comparison group.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Institute for biometry and clinical epidemiology, Charité University Berlin, Germany: collaborator
• Institute for transfusion medicine, Charité University Berlin, Germany: collaborator
• Einstein center digital future: collaborator

Study Sites (1)

Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin

Berlin, State of Berlin, 12203, Germany

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Univ.-Prof. Dr. med., Head of Department

Study Record Dates

• First Submitted: July 5, 2021
• First Posted: August 6, 2021
• Study Start: June 23, 2021
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)