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Safety and Efficacy of a 6% Hydroxyethyl Starch (HES) Solution Versus an Electrolyte Solution in Trauma Patients (TETHYS)

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ClinicalTrials.gov Identifier: NCT03338218
Recruitment Status : Recruiting
First Posted : November 9, 2017
Last Update Posted : July 11, 2019
Sponsor:
Collaborators:
Fresenius Kabi
European Society of Anaesthesiology
Information provided by (Responsible Party):
B. Braun Melsungen AG

Brief Summary:
The aim of the study is to investigate the safety of a 6% Hydroxyethylstarch (HES) solution (Volulyte 6%) versus an electrolyte solution (Ionolyte) in trauma patients.

Condition or disease Intervention/treatment Phase
Hypovolemia Drug: Volulyte 6% Drug: Ionolyte Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pragmatic, Prospective, Randomized, Controlled, Double-blind, Multi-centre, Multinational Study on the Safety and Efficacy of a 6% Hydroxyethyl Starch (HES) Solution Versus an Electrolyte Solution in Trauma Patients
Actual Study Start Date : February 23, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Volulyte 6%
Volulyte 6% solution for infusion
Drug: Volulyte 6%
Solution for infusion
Other Name: Hydroxyethylstarch 130

Active Comparator: Ionolyte
Ionolyte solution for infusion
Drug: Ionolyte
Solution for infusion
Other Name: Ionolyte Electrolyte Solution




Primary Outcome Measures :
  1. Composite endpoint of 90 day mortality and 90 day renal failure defined as biomarker increase as defined by AKIN stage 2 or RIFLE injury stage or need for RRT at any time during the first 3 month. [ Time Frame: 90 days ]

Secondary Outcome Measures :
  1. Serum creatinine (SCr) [ Time Frame: 7 days ]
  2. Cystatin-C [ Time Frame: 7 days ]
  3. Urine output [ Time Frame: 7 days ]
  4. Need for Renal Replacement Therapy (RRT) [ Time Frame: 90 days ]
    Days on RRT

  5. Platelet count [ Time Frame: 3 days ]
  6. International norm ratio (INR) [ Time Frame: 3 days ]
  7. Adverse Events [ Time Frame: 90 days ]
  8. Mortality [ Time Frame: 90 days ]
  9. Length of Stay in ICU [ Time Frame: 90 ]
  10. C-reactive protein [ Time Frame: 3 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion:

  • Male or female adult patients ≥18 and ≤ 80 years of age. Women of child bearing potential must test negative on standard pregnancy test (urine or serum) (as soon as possible during emergency care)
  • Patients with blunt or penetrating trauma suffering from estimated blood loss of ≥ 500 ml
  • Initial surgery deemed necessary within 24 hrs after trauma
  • Deferred signed written informed consent form or as locally required
  • No signs of intracranial or cerebral haemorrhage
  • Base excess < - 4 mEq/l
  • Administration of less than 15 ml/kg body weight colloid between trauma injury and hospital admission.

Exclusion:

  • Hypersensitivity to the active substances or to any of the other excipients of the Investigational Products
  • Body weight ≥ 140 kg
  • Patients expected to die within 24h after traumatic injury
  • Sepsis
  • Burns
  • Renal impairment (AKIN stage ≥ 1) or acute and/or chronic Renal Replacement Therapy
  • Critically ill patients (typically admitted to the intensive care unit)
  • Hyperhydration
  • Pulmonary oedema
  • Dehydration
  • Hyperkalaemia
  • Severe hypernatraemia
  • Severe hyperchloraemia
  • Severely impaired hepatic function
  • Congestive heart failure
  • Severe coagulopathy
  • Organ transplant patients
  • Metabolic alkalosis
  • Simultaneous participation in another interventional clinical trial (drugs or medical devices studies)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03338218


Contacts
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Contact: Study Manager +49-5661-71-0 studies@bbraun.com

Locations
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Belgium
Ziekenhuis Oost-Limburg-ZOL Not yet recruiting
Genk, Belgium
Contact: Pascal Vanelderen, Prof. Dr. med.         
Principal Investigator: Pascal Vaneldern, Prof. Dr. med.         
Germany
Universitätsklinikum Aachen Recruiting
Aachen, Germany
Contact: Rolf Roissant, Prof. Dr. med.         
Principal Investigator: Rolf Roissant, Prof. Dr. med.         
Klinik für Anästhesiologie mit Schwerpunkt operative Intensivmedizin (CCM/CVK), Charité-Universitätsmedizin Berlin Not yet recruiting
Berlin, Germany, 13353
Contact: Claudia Spies, Prof. Dr. med.         
Principal Investigator: Claudia Spies, Prof. Dr. med.         
Universitätsklinikum Bonn Not yet recruiting
Bonn, Germany
Contact: Maria Wittmann, Prof. Dr. med.         
Principal Investigator: Maria Wittmann, Prof. Dr. med.         
Universitätsklinikum Carl Gustav Carus Dresden Not yet recruiting
Dresden, Germany, 01307
Contact: Marcelo Gama de Abreu, Prof. Dr. med.         
Principal Investigator: Marcelo Gama de Abreu, Prof. Dr. med.         
Universitätsklinikum Frankfurt Recruiting
Frankfurt, Germany
Contact: Kai Zacharowski, Prof. Dr. med.         
Principal Investigator: Kai Zacharowski, Prof. Dr. med.         
University Hospital Schleswig-Holstein Campus Kiel Not yet recruiting
Kiel, Germany, 24105
Contact: Matthias Gruenewald, Prof. Dr. med.         
Principal Investigator: Matthias Gruenewald, Prof. Dr. med.         
Klinikum Oldenburg AÖR Not yet recruiting
Oldenburg, Germany
Contact: Andreas Weyland, Prof. Dr. med.         
Principal Investigator: Andreas Weyland, Prof. Dr. med.         
Netherlands
University Medical Center (UMC) Maastricht Not yet recruiting
Maastricht, Netherlands
Contact: Wolfgang Buhre, Prof. Dr. med.         
Principal Investigator: Wolfgang Buhre, Prof. Dr. med.         
Spain
Hospital Universitari i Politecnic la Fe Recruiting
Valencia, Spain
Contact: Oscar Diaz-Cambronero, Dr.         
Principal Investigator: Oscar Diaz-Cambronero, Dr.         
Sponsors and Collaborators
B. Braun Melsungen AG
Fresenius Kabi
European Society of Anaesthesiology
Investigators
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Study Chair: Wolfgang F. Buhre, Prof. Dr. med. Department of Anesthesiology and Pain Management, Maastricht University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: B. Braun Melsungen AG
ClinicalTrials.gov Identifier: NCT03338218     History of Changes
Other Study ID Numbers: HC-G-H-1505
First Posted: November 9, 2017    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by B. Braun Melsungen AG:
Hydroxyethylstarch (HES)

Additional relevant MeSH terms:
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Hypovolemia
Pathologic Processes
Hydroxyethyl Starch Derivatives
Pharmaceutical Solutions
Plasma Substitutes
Blood Substitutes