Clinical Trials Logo

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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04993170
Study type Observational
Source Charite University, Berlin, Germany
Contact
Status Recruiting
Phase
Start date June 23, 2021
Completion date May 22, 2025

See also
  Status Clinical Trial Phase
Recruiting NCT05335525 - Post-market Clinical Investigation of the Angio-Sealâ„¢ VIP VCD (ANGIO-SEAL CLOSE)
Completed NCT02583854 - Comparison Study of Compression Devices Used in Transradial Coronary Angiography N/A
Recruiting NCT05977946 - Delivering Transcutaneous Auricular Neurostimulation to Regulate Platelet Activity in Healthy Human Subjects N/A
Completed NCT01388491 - A Multinational Study to Evaluate the Effects of a 28-Day Oral Contraceptive on Hemostatic Parameters in Healthy Women Phase 2
Recruiting NCT04728087 - ACCEL Absorbable Hemostat N/A
Recruiting NCT05323448 - Efficacy of ARISTA-AH for Restoring Hemostasis Following Posterior Long-segment Spinal Fusion. N/A
Recruiting NCT06078735 - Vascular Closure With a Device Compared to Manual Compression After Atrial Fibrillation Ablation: The LockeT II Study N/A
Completed NCT03907111 - Compare the Hemostatic Effectiveness of Chitosan Gauze With Traditional Gauze on Open Wound on 10 Participants. N/A
Recruiting NCT05875272 - Interchangeability of Arterial Coagulation and Venous Coagulation, in the Context of Cardiac Surgeries Under Cardiopulmonary Bypass, Using the DMDiv Hemochron Signature Elite
Completed NCT04593667 - Randomized Study of Accelerated Radial Arterial Hemostasis N/A
Completed NCT01252186 - A Multicenter Study to Evaluate the Effects of a 91-Day Extended Cycle Oral Contraceptive on Hemostatic Parameters in Healthy Women Phase 2
Terminated NCT00802633 - Radical Cystectomy: Can We Improve Our Surgical Technique With the Ligasure Impact Tissue-Sealing Device? N/A
Completed NCT02034799 - Phase IV Bioseal Study in Brain Tumor Surgery Phase 4
Terminated NCT03873168 - Post-Market Evaluation of HEMOBLASTâ„¢ Bellows in Open Gynecological, Urological, ENT, Head, Neck, and Vascular Surgeries
Recruiting NCT04377490 - Thrombo Embolic Events in Hospitalized Patients With Covid-19 Serious Acute Pneumopathy
Completed NCT00449410 - Silent Cerebrovascular Lesion and Cognitive Decline Prevention by Cholesterol Lowering in Elderly AF Patients Phase 4
Completed NCT03873181 - Post-Market Evaluation of HEMOBLASTâ„¢ Bellows in Laparoscopic Abdominal, Gynecological, and Urological Surgery
Completed NCT04660721 - A Study Evaluating the Safety and Preliminary Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Elective Hepatic Surgery Phase 1/Phase 2
Recruiting NCT05653843 - MANTIS Endoscopic Clipping Study
Completed NCT00658723 - The Fibrin Patch Soft Tissue Study Phase 2