Clinical Trials Logo
  1. Home
  2. Blood Loss, Surgical
  3. NCT05077124
  4. Details
NCT05077124 Clinical Trial

Safe and Timely Antithrombotic Removal (STAR) Registry

Blood Loss, Surgical Clinical Trial

Official title:
Safe and Timely Antithrombotic Removal (STAR) Registry: International Registry on the Use of CytoSorb for Removal of Antithrombotic Agents in the Acute Hospital Setting

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05077124
Other study ID # O05
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 30, 2021
Est. completion date September 30, 2025

Study information
Verified date March 2024
Source CytoSorbents, Inc
Contact Cindy Rechner, PhD
Phone +49 30 654 99 145
Email star@cytosorbents.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This registry will capture real-world clinical use patterns and associated clinical outcomes with the use of CytoSorb for the removal of antithrombotic agents.

Description:

The STAR Registry will collect patient-level clinical data on antithrombotic removal with CytoSorb. The decision to use CytoSorb in this clinical setting is based on the clinical rationale of mitigating the high risk of bleeding events that is directly linked to the presence of the antithrombotic agent. This registry is to capture real-world clinical use patterns and associated clinical outcomes with the use of CytoSorb. Data of retrospective and prospective patients will be included in the registry. Safety will be assessed by collection of (at least possibly) device-related adverse events. Data collection is done up to 30 days post-operation.

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date September 30, 2025
Est. primary completion date September 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - CytoSorb utilization for antithrombotic removal - Informed consent for prospective registry participation Exclusion Criteria: • Use of CytoSorb for purpose other than antithrombotic removal

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• CytoSorb
Sorbent hemoperfusion system

Locations
Country Name City State
Austria Universitätsklinikum Graz Graz
Austria Medizinische Universität Innsbruck Innsbruck
Austria Klinikum Klagenfurt am Wörthersee Klagenfurt
Austria Medical University of Vienna Vienna
Belgium OLV ziekenhuis Aalst VZW Aalst
Belgium Cliniques Universitaires Saint-Luc Bruxelles
Germany MediClin Herzzentrum Coswig Coswig
Germany Herzchirurgische Klinik Erlangen Erlangen
Germany Universitätsklinikum Essen Essen
Germany Asklepios Kliniken Hamburg GmbH Hamburg
Germany Medizinische Hochschule Hannover Hannover
Germany Universitätsklinikum Heidelberg - Klinik für Herzchirurgie Heidelberg
Germany Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Herz- und Gefäßchirurgie Kiel
Germany Deutsches Herzzentrum Mu¨nchen München
Germany Artemed Klinikum München Süd GmbH & Co. KG Munich
Germany LMU Klinikum Großhadern Munich
Germany Klinikum Nürnberg Nürnberg
Germany Klinikum Oldenburg AöR Oldenburg
Germany Krankenhaus der Barmherzigen Brüder Trier Trier
Germany Universitätsklinikum Ulm Ulm
Sweden Skåne University Hospital Lund Lund
United Kingdom Royal Brompton & Harefield Clinical Group (part of Guy's and St Thomas' NHS Foundation TRUST) London
United Kingdom Sheffield Teaching Hospitals NHS Foundation Trust Sheffield

Sponsors (1)
Lead Sponsor Collaborator
CytoSorbents, Inc

Countries where clinical trial is conducted

Austria,  Belgium,  Germany,  Sweden,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Bleeding complications including requirements for transfusions and other blood products Assessed until postoperative day (POD) 3, date of ICU discharge, or date of death, whatever comes first; on average 3 days
See also
  Status Clinical Trial Phase
Completed NCT04114253 - QStat in Liver Transplant
Active, not recruiting NCT03651154 - Hypovolemic Phlebotomy to Reduce Blood Transfusions in Major Hepatic Resections N/A
Recruiting NCT04519593 - ABSOLUTELY: A Temporary Uterine Blood Supply Occlusion for Laparoscopic Myomectomy in Patients With UTErine LeiomYoma N/A
Completed NCT02043132 - Tranexamic Acid in Reverse Total Shoulder Arthroplasty Phase 2/Phase 3
Withdrawn NCT00861367 - Prospective Double-blind Study for the Use of Aspirin During Transurethral Surgery of the Bladder or the Prostate N/A
Terminated NCT03246919 - Ideal Time of Oxytocin Infusion During Cesarean Section Phase 4
Completed NCT04443920 - Tranexamic Acid for Total Knee Arthroscopy Phase 4
Withdrawn NCT04933253 - Mediastinal Temperature and Post-operative Bleeding N/A
Recruiting NCT02938962 - Intravenous vs. Topical Tranexamic Acid in Revision THA (VITALITY-X) Phase 4
Recruiting NCT02130752 - Ultrasonic Scalpel vs. Monopolar Electrocautery for D2 Distal Gastric Carcinoma Surgery N/A
Recruiting NCT05164809 - Effect of Electrosurgery on Blood Loss and Intraoperative Transfusions in Musculoskeletal Tumor Surgery
Not yet recruiting NCT04574128 - Retransfusion or Not of Cardiotomy Blood N/A
Completed NCT02911831 - IV Tranexamic Acid Prior to Hysterectomy Early Phase 1
Completed NCT02740374 - Evaluation of Thromboelastometry (ROTEM) During Spinal Surgery N/A
Enrolling by invitation NCT05474027 - Reducing Hypotensive Anesthesia Use With TXA During Orthognathic Surgery Phase 4
Completed NCT05391607 - Comparison Between Hyperoncotic and Isooncotic Albumin to Support Blood Loss Replacement Phase 4
Completed NCT03152461 - Evaluation of the Clinical Performance of the Quantra System With the Quantra Surgical Cartridge
Recruiting NCT02441751 - Intraoperative Volume Management and QT Interval
Completed NCT01053169 - Observational Study of Prophylaxis and Treatment of Acute Perioperative Bleeding With Beriplex® P/N (Probe Study) N/A
Completed NCT00656396 - Point of Care Coagulation Testing in Patients Undergoing Major Surgery Phase 3