Clinical trial NCT04993170: Systematic Analysis of a Standardized Questionnaire to Detect Possible Bleeding Disorders and Its Impact on Perioperative Hemostasis Management
Official title: Systematic Analysis of a Standardized Questionnaire to Detect Possible Bleeding Disorders Used in Clinical Routine During Anaesthesiological Preoperative Assessment and Its Impact on Perioperative Hemostasis Management
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Perioperative Hemorrhage
Hemostasis
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Institute for biometry and clinical epidemiology, Charité University Berlin, Germany
name: Institute for transfusion medicine, Charité University Berlin, Germany
name: Einstein center digital future
First posted: 2021-08-06
Enrollment: 5004
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Relative frequency of changes in the initially planned perioperative procedure
timeFrame: Perioperative period
Secondary outcomes:
measure: Perioperative complications
timeFrame: Perioperative period
measure: Diagnostic discrepancy
timeFrame: Perioperative period
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin
Study officials:
References: