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

NCT ID: NCT03338218

Last Updated: 2022-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 238 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-23
• Study Completion Date: 2022-06-25

Brief 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.

Conditions

Hypovolemia Due to Acute Blood Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Volulyte 6%

Volulyte 6% solution for infusion

Group Type: EXPERIMENTAL

Volulyte 6%

Intervention Type: DRUG

Solution for infusion

Ionolyte

Ionolyte solution for infusion

Group Type: ACTIVE_COMPARATOR

Ionolyte

Intervention Type: DRUG

Solution for infusion

Interventions

Volulyte 6%

Solution for infusion

Intervention Type: DRUG

Ionolyte

Solution for infusion

Intervention Type: DRUG

Other Intervention Names

Hydroxyethyl starch 130; Ionolyte Electrolyte Solution

Eligibility Criteria

Inclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

B. Braun Melsungen AG

INDUSTRY

Sponsor Role: collaborator

European Society of Anaesthesiology and Intensive Care

OTHER

Sponsor Role: collaborator

Fresenius Kabi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wolfgang F. Buhre, Prof. Dr. med.

Role: STUDY_CHAIR

Department of Anesthesiology and Pain Management, Maastricht University, The Netherlands

Locations

Ziekenhuis Oost-Limburg-ZOL

Genk, , Belgium

Fakultni nemocnice Brno

Brno, , Czechia

Military University Hospital

Prague, , Czechia

CHRU Nancy - Hôpital Central

Nancy, , France

Hôpital de Hautepierre

Strasbourg, , France

Universitätsklinikum Aachen

Aachen, , Germany

Universitätsklinikum Carl Gustav Carus Dresden

Dresden, , Germany

Universitätsklinikum Frankfurt

Frankfurt, , Germany

University Hospital Schleswig-Holstein Campus Kiel

Kiel, , Germany

Academic Medical Center (AMC) Anesthesiology

Amsterdam, , Netherlands

University Medical Center (UMC) Maastricht

Maastricht, , Netherlands

Groote Schuur Hospital

Cape Town, , South Africa

Gama Research Centre Emergency Department, Leratong Hospital

Germiston, , South Africa

Gama Research Centre

Germiston, , South Africa

Chris Hani Baragwanath Hospital

Johannesburg, , South Africa

Trident Clinical, Homestead Medical Centre

Kimberley, , South Africa

Steve Biko Academic Hospital

Pretoria, , South Africa

FCRN Clinical Trials Centre

Vereeniging, , South Africa

Clinical Projects Research SA

Worcester, , South Africa

Hospital Universitario Gregorio Marañón

Madrid, , Spain

Hospital Clinico Universitario

Valencia, , Spain

Hospital Universitari i Politecnic la Fe

Valencia, , Spain

Countries

Belgium; Czechia; France; Germany; Netherlands; South Africa; Spain

References

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.

Reference Type: DERIVED

PMID: 35655234 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30017128 (View on PubMed)

Other Identifiers

HE06-021-CP4

Identifier Type: OTHER

Identifier Source: secondary_id

HC-G-H-1505

Identifier Type: -

Identifier Source: org_study_id