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

August 4, 2022 updated by: Fresenius Kabi

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
238

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Genk, Belgium
        • Ziekenhuis Oost-Limburg-ZOL
  • Czechia
      • Brno, Czechia
        • Fakultní Nemocnice Brno
      • Prague, Czechia
        • Military University Hospital
  • France
      • Nancy, France
        • CHRU Nancy - Hôpital central
      • Strasbourg, France
        • Hopital de Hautepierre
  • Germany
      • Aachen, Germany
        • Universitätsklinikum Aachen
      • Dresden, Germany
        • Universitätsklinikum Carl Gustav Carus Dresden
      • Frankfurt, Germany
        • Universitätsklinikum Frankfurt
      • Kiel, Germany
        • University Hospital Schleswig-Holstein Campus Kiel
  • Netherlands
      • Amsterdam, Netherlands
        • Academic Medical Center (AMC) Anesthesiology
      • Maastricht, Netherlands
        • University Medical Center (UMC) Maastricht
  • South Africa
      • Cape Town, South Africa
        • Groote Schuur Hospital
      • Germiston, South Africa
        • Gama Research Centre Emergency Department, Leratong Hospital
      • Germiston, South Africa
        • Gama Research Centre
      • Johannesburg, South Africa
        • Chris Hani Baragwanath Hospital
      • Kimberley, South Africa
        • Trident Clinical, Homestead Medical Centre
      • Pretoria, South Africa
        • Steve Biko Academic Hospital
      • Vereeniging, South Africa
        • FCRN Clinical Trials Centre
      • Worcester, South Africa
        • Clinical Projects Research SA
  • Spain
      • Madrid, Spain
        • Hospital Universitario Gregorio Marañón
      • Valencia, Spain
        • Hospital Clinico Universitario
      • Valencia, Spain
        • Hospital Universitari I Politècnic La Fe

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion:

  • Male or female adult patients ≥18 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 hemorrhage
  • 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 chronic) or acute and/or chronic Renal Replacement Therapy
  • Critically ill patients (typically admitted to the intensive care unit)
  • Hyperhydration
  • Pulmonary edema
  • Dehydration
  • Hyperkalemia
  • Severe hypernatremia
  • Severe hyperchloremia
  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Volulyte 6%
Volulyte 6% solution for infusion
Drug: Volulyte 6%
Solution for infusion
Other Names:
  • Hydroxyethyl starch 130
Active Comparator: Ionolyte
Ionolyte solution for infusion
Drug: Ionolyte
Solution for infusion
Other Names:
  • Ionolyte Electrolyte Solution

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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 months.
Time Frame: 90 days
90 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 90 days after randomization
90 days after randomization
Serum creatinine
Time Frame: 7 days post-trauma
7 days post-trauma
Serum creatinine-based estimated glomerular filtration rate
Time Frame: 7 days post-trauma
7 days post-trauma
Cystatin-C
Time Frame: 3 days post-trauma
3 days post-trauma
Cystatin-C-based mean estimated glomerular filtration rate
Time Frame: 3 days post-trauma
3 days post-trauma
AKIN stages
Time Frame: 7 days post-trauma
7 days post-trauma
Highest AKIN stage reached on each day during the first week
Time Frame: 7 days post-trauma
7 days post-trauma
RIFLE stages
Time Frame: 7 days post-trauma
7 days post-trauma
Urine output (if available)
Time Frame: 7 days post-trauma
7 days post-trauma
Days on Renal Replacement Therapy
Time Frame: 90 days after randomization
90 days after randomization
Patients on Renal Replacement Therapy
Time Frame: 90 days after randomization
90 days after randomization
Platelet count
Time Frame: 3 days post-trauma
3 days post-trauma
International normalized ratio
Time Frame: 3 days post-trauma
3 days post-trauma
Activated partial thromboplastin time
Time Frame: 3 days post-trauma
3 days post-trauma
Adverse Events
Time Frame: 90 days after randomization
90 days after randomization
Length of Stay in ICU/hospital
Time Frame: 90 days after randomization
90 days after randomization
C-reactive protein
Time Frame: 3 days post-trauma
3 days post-trauma
Hours on mechanical ventilation
Time Frame: 7 days post-trauma
7 days post-trauma
Total volume of administered investigational products
Time Frame: until 24 hours after investigational product treatment start
until 24 hours after investigational product treatment start
Fluid balance
Time Frame: 7 days post-trauma
Sum of volume of all intravenous medication (including investigational product and blood products) minus sum of volume of urine output (if available), drainage and estimated due to surgeries and trauma
7 days post-trauma
Heart rate
Time Frame: 7 days post-trauma
7 days post-trauma
Temperature
Time Frame: 7 days post-trauma
7 days post-trauma
Mean arterial pressure
Time Frame: 7 days post-trauma
7 days post-trauma
Systolic arterial blood pressure
Time Frame: 7 days post-trauma
7 days post-trauma
Diastolic arterial blood pressure
Time Frame: 7 days post-trauma
7 days post-trauma
Central venous pressure (if available)
Time Frame: 7 days post-trauma
7 days post-trauma
Partial pressure of carbon dioxide
Time Frame: 3 days post-trauma
3 days post-trauma
Partial pressure of oxygen
Time Frame: 3 days post-trauma
3 days post-trauma
Bicarbonate
Time Frame: 3 days post-trauma
3 days post-trauma
Arterial oxygen saturation
Time Frame: 3 days post-trauma
3 days post-trauma
Hemoglobin
Time Frame: 3 days post-trauma
3 days post-trauma
Hematocrit
Time Frame: 3 days post-trauma
3 days post-trauma
pH
Time Frame: 3 days post-trauma
3 days post-trauma
Base excess
Time Frame: 3 days post-trauma
3 days post-trauma
Lactate
Time Frame: 3 days post-trauma
3 days post-trauma
Central venous oxygen saturation (if available)
Time Frame: 3 days post-trauma
3 days post-trauma
Serum sodium
Time Frame: 3 days post-trauma
3 days post-trauma
Serum potassium
Time Frame: 3 days post-trauma
3 days post-trauma
Serum calcium
Time Frame: 3 days post-trauma
3 days post-trauma
Serum chloride
Time Frame: 3 days post-trauma
3 days post-trauma

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fresenius Kabi

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
B. Braun Melsungen AG
European Society of Anaesthesiology and Intensive Care

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Wolfgang F. Buhre, Prof. Dr. med., Department of Anesthesiology and Pain Management, Maastricht University, The Netherlands

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 23, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 25, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 25, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 1, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 7, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 9, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 5, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HC-G-H-1505
  • HE06-021-CP4 (Other Identifier: Fresenius Kabi)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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