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

NCT03338218 | Completed Phase 4 DMC

• 2 other identifiers: HC-G-H-1505HE06-021-CP4
• Study Type: interventional
• Target: 238
• Locations: 7 countries
• Sites: 22

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

Keywords

Hydroxyethyl starch; HES; HES 130

Outcome Measures

Primary Outcomes (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.

  90 days

Secondary Outcomes (40)

• Serum creatinine

  7 days post-trauma

• Serum creatinine-based estimated glomerular filtration rate

  7 days post-trauma

• Cystatin-C

  3 days post-trauma

• Cystatin-C-based mean estimated glomerular filtration rate

  3 days post-trauma

• AKIN stages

  7 days post-trauma

Study Arms (2)

Volulyte 6%

EXPERIMENTAL

Volulyte 6% solution for infusion

Drug: Volulyte 6%

Ionolyte

ACTIVE COMPARATOR

Ionolyte solution for infusion

Drug: Ionolyte

Interventions

Volulyte 6% DRUG

Solution for infusion

Also known as: Hydroxyethyl starch 130

Volulyte 6%

Ionolyte DRUG

Solution for infusion

Also known as: Ionolyte Electrolyte Solution

Ionolyte

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fresenius Kabi: lead
• B. Braun Melsungen AG: collaborator
• European Society of Anaesthesiology and Intensive Care: collaborator

Study Sites (22)

Ziekenhuis Oost-Limburg-ZOL

Genk, Belgium

Location

Fakultni nemocnice Brno

Brno, Czechia

Location

Military University Hospital

Prague, Czechia

Location

CHRU Nancy - Hôpital Central

Nancy, France

Location

Hôpital de Hautepierre

Strasbourg, France

Location

Universitätsklinikum Aachen

Aachen, Germany

Location

Universitätsklinikum Carl Gustav Carus Dresden

Dresden, Germany

Location

Universitätsklinikum Frankfurt

Frankfurt, Germany

Location

University Hospital Schleswig-Holstein Campus Kiel

Kiel, Germany

Location

Academic Medical Center (AMC) Anesthesiology

Amsterdam, Netherlands

Location

University Medical Center (UMC) Maastricht

Maastricht, Netherlands

Location

Groote Schuur Hospital

Cape Town, South Africa

Location

Gama Research Centre Emergency Department, Leratong Hospital

Germiston, South Africa

Location

Gama Research Centre

Germiston, South Africa

Location

Chris Hani Baragwanath Hospital

Johannesburg, South Africa

Location

Trident Clinical, Homestead Medical Centre

Kimberley, South Africa

Location

Steve Biko Academic Hospital

Pretoria, South Africa

Location

FCRN Clinical Trials Centre

Vereeniging, South Africa

Location

Clinical Projects Research SA

Worcester, South Africa

Location

Hospital Universitario Gregorio Marañón

Madrid, Spain

Location

Hospital Clinico Universitario

Valencia, Spain

Location

Hospital Universitari i Politecnic la Fe

Valencia, Spain

Location

Related Publications (2)

• 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.

  PMID: 35655234 DERIVED

• 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.

  PMID: 30017128 DERIVED

MeSH Terms

Interventions

Hydroxyethyl Starch Derivatives

Intervention Hierarchy (Ancestors)

Starch; Dietary Carbohydrates; Carbohydrates; Glucans; Polysaccharides

Study Officials

• Wolfgang F. Buhre, Prof. Dr. med.

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2017
• First Posted: November 9, 2017
• Study Start: February 23, 2019
• Primary Completion: June 25, 2022
• Study Completion: June 25, 2022
• Last Updated: August 5, 2022

Record last verified: 2022-08

Locations

BE (1); ZA (8); FR (2); DE (4); NL (2); CZ (2); ES (3)