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

Hemostasis Clinical Trial

— PrEdict  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04993170
• Other study ID #: EA4/181/20
• Status: Recruiting
• Start date: June 23, 2021
• Est. completion date: May 22, 2025

Study information

• Verified date: February 2024
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: May 22, 2025
• Est. primary completion date: May 22, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Hemorrhage
• Hemostasis
• Hemostatic Disorders

Intervention

Diagnostic Test:
• 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

Locations

Country	Name	City	State
Germany	Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin	Berlin

Sponsors (4)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Einstein center digital future, Institute for biometry and clinical epidemiology, Charité University Berlin, Germany, Institute for transfusion medicine, Charité University Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Perioperative complications	Compared to a retrospective control group in which no standardized questionnaire was used, the use of a standardized questionnaire and the targeted diagnostics initiated in case of abnormalities lead to; lower blood loss (estimated in ml, qualitatively); a lower transfusion rate during surgery (number of red cell concentrates); less time spent in the recovery room (hours:minutes); a lower rate of revision surgery due to postoperative bleeding (number of patients); fewer organ complications (number of patients, organ failure defined and diagnosed by attending physician)	Perioperative period
Secondary	Diagnostic discrepancy	There is a discrepancy between the number of patients, for whom additional diagnostics and measures ,based on the evaluation of the questionnaire,are required on the one hand, and the number ob patients, fo whom these additional diagnostics and measures are actually performed at the time of surgery on the other hand. The relative frequency of these discrepancies should be determined.; Additional diagnostics and measures are: extended coagulation diagnostics; hemostaseological consultation preoperatively	Perioperative period