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Hypovolemia Due to Acute Blood LossPhase 4TETHYSNCT03338218

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

A Phase 4 study testing Volulyte 6% and Ionolyte in people with Hypovolemia Due to Acute Blood Loss, run by Fresenius Kabi at 22 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hypovolemia Due to Acute Blood Loss
What is being tested?
Volulyte 6% and Ionolyte
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
238 participants
Where
22 sitesin 7 countries
Study dates
23 Feb 2019to 25 Jun 2022
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 19Show fewer
  • 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)

Trial locations and contacts

22 sites in 7 countries.

22 sites in 7 countries

South Africa8 sites

  • Groote Schuur Hospital

    Cape Town

  • Gama Research Centre Emergency Department, Leratong Hospital

    Germiston

  • Gama Research Centre

    Germiston

  • Chris Hani Baragwanath Hospital

    Johannesburg

  • Trident Clinical, Homestead Medical Centre

    Kimberley

  • Steve Biko Academic Hospital

    Pretoria

  • FCRN Clinical Trials Centre

    Vereeniging

  • Clinical Projects Research SA

    Worcester

Other trials in South Africa

Germany4 sites

  • Universitätsklinikum Aachen

    Aachen

  • Universitätsklinikum Carl Gustav Carus Dresden

    Dresden

  • Universitätsklinikum Frankfurt

    Frankfurt

  • University Hospital Schleswig-Holstein Campus Kiel

    Kiel

Other trials in Germany

Spain3 sites

  • Hospital Universitario Gregorio Marañón

    Madrid

  • Hospital Clinico Universitario

    Valencia

  • Hospital Universitari i Politecnic la Fe

    Valencia

Other trials in Spain

Czechia2 sites

  • Fakultni nemocnice Brno

    Brno

  • Military University Hospital

    Prague

Other trials in Czechia

France2 sites

  • CHRU Nancy - Hôpital Central

    Nancy

  • Hôpital de Hautepierre

    Strasbourg

Other trials in France

Netherlands2 sites

  • Academic Medical Center (AMC) Anesthesiology

    Amsterdam

  • University Medical Center (UMC) Maastricht

    Maastricht

Other trials in Netherlands

Belgium1 site

  • Ziekenhuis Oost-Limburg-ZOL

    Genk

Other trials in Belgium

About this study

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

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.

Being tested
Volulyte 6%, Ionolyte
Keywords
Hydroxyethyl starch, HES, HES 130

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Volulyte 6%Drug

    Also called Hydroxyethyl starch 130

    Solution for infusion

  • IonolyteDrug

    Also called Ionolyte Electrolyte Solution

    Solution for infusion

Study groups in NCT03338218
Study groupRoleWhat they receive
Volulyte 6%ExperimentalVolulyte 6% solution for infusion
Receives: Drug: Volulyte 6%
IonolyteActive comparatorIonolyte solution for infusion
Receives: Drug: Ionolyte

What is being measured

The primary outcome is the main question the study is designed to answer.

  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 months.

    Measured: 90 days

Secondary outcomes (40)

  1. Serum creatinine

    Measured: 7 days post-trauma

  2. Serum creatinine-based estimated glomerular filtration rate

    Measured: 7 days post-trauma

  3. Cystatin-C

    Measured: 3 days post-trauma

  4. Cystatin-C-based mean estimated glomerular filtration rate

    Measured: 3 days post-trauma

  5. AKIN stages

    Measured: 7 days post-trauma

  6. Highest AKIN stage reached on each day during the first week

    Measured: 7 days post-trauma

  7. RIFLE stages

    Measured: 7 days post-trauma

  8. Urine output (if available)

    Measured: 7 days post-trauma

  9. Days on Renal Replacement Therapy

    Measured: 90 days after randomization

  10. Patients on Renal Replacement Therapy

    Measured: 90 days after randomization

  11. Platelet count

    Measured: 3 days post-trauma

  12. International normalized ratio

    Measured: 3 days post-trauma

  13. Activated partial thromboplastin time

    Measured: 3 days post-trauma

  14. Adverse Events

    Measured: 90 days after randomization

  15. Mortality

    Measured: 90 days after randomization

  16. Length of Stay in ICU/hospital

    Measured: 90 days after randomization

  17. C-reactive protein

    Measured: 3 days post-trauma

  18. Hours on mechanical ventilation

    Measured: 7 days post-trauma

  19. Total volume of administered investigational products

    Measured: until 24 hours after investigational product treatment start

  20. Fluid balance

    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

    Measured: 7 days post-trauma

  21. Heart rate

    Measured: 7 days post-trauma

  22. Temperature

    Measured: 7 days post-trauma

  23. Mean arterial pressure

    Measured: 7 days post-trauma

  24. Systolic arterial blood pressure

    Measured: 7 days post-trauma

  25. Diastolic arterial blood pressure

    Measured: 7 days post-trauma

  26. Central venous pressure (if available)

    Measured: 7 days post-trauma

  27. Partial pressure of carbon dioxide

    Measured: 3 days post-trauma

  28. Partial pressure of oxygen

    Measured: 3 days post-trauma

  29. Bicarbonate

    Measured: 3 days post-trauma

  30. Arterial oxygen saturation

    Measured: 3 days post-trauma

  31. Hemoglobin

    Measured: 3 days post-trauma

  32. Hematocrit

    Measured: 3 days post-trauma

  33. pH

    Measured: 3 days post-trauma

  34. Base excess

    Measured: 3 days post-trauma

  35. Lactate

    Measured: 3 days post-trauma

  36. Central venous oxygen saturation (if available)

    Measured: 3 days post-trauma

  37. Serum sodium

    Measured: 3 days post-trauma

  38. Serum potassium

    Measured: 3 days post-trauma

  39. Serum calcium

    Measured: 3 days post-trauma

  40. Serum chloride

    Measured: 3 days post-trauma

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2017
  2. Study start23 Feb 2019
  3. Primary completion25 Jun 2022
  4. Study completion25 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
238 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03338218
Sponsor's protocol ID
HC-G-H-1505
Other IDs
HE06-021-CP4
Acronym
TETHYS
Status last verified
Aug 2022
First submitted
1 Nov 2017
Last updated
5 Aug 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Palma CD, Mamba M, Geldenhuys J, Fadahun O, Rossaint R, Zacharowski K, Brand M, Diaz-Cambronero O, Belda J, Westphal M, Brauer U, Dormann D, Dehnhardt T, Hernandez-Gonzalez M, Schmier S, de Korte D, Plani F, Buhre W. 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: study protocol for the TETHYS study. Trials. 2022 Jun 2;23(1):456. doi: 10.1186/s13063-022-06390-x.

    PubMed 35655234

  • Chappell D, Jacob M. Should hydroxyethyl starch be banned? Lancet. 2018 Jul 14;392(10142):118. doi: 10.1016/S0140-6736(18)31174-7. No abstract available.

    PubMed 30017128

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Volulyte 6% and Ionolyte in people with Hypovolemia Due to Acute Blood Loss, run by Fresenius Kabi at 22 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in South Africa, Germany, Spain, Czechia, France and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03338218, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2022.

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