Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2025-12-26 @ 3:51 AM
Study NCT ID:
NCT03338218
Status:
COMPLETED
Last Update Posted:
2022-08-05
First Post:
2017-11-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of a 6% Hydroxyethyl Starch (HES) Solution Versus an Electrolyte Solution in Trauma Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D006895', 'term': 'Hydroxyethyl Starch Derivatives'}], 'ancestors': [{'id': 'D013213', 'term': 'Starch'}, {'id': 'D004040', 'term': 'Dietary Carbohydrates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D005936', 'term': 'Glucans'}, {'id': 'D011134', 'term': 'Polysaccharides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 238}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-06-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-04', 'studyFirstSubmitDate': '2017-11-01', 'studyFirstSubmitQcDate': '2017-11-07', 'lastUpdatePostDateStruct': {'date': '2022-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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.', 'timeFrame': '90 days'}], 'secondaryOutcomes': [{'measure': 'Serum creatinine', 'timeFrame': '7 days post-trauma'}, {'measure': 'Serum creatinine-based estimated glomerular filtration rate', 'timeFrame': '7 days post-trauma'}, {'measure': 'Cystatin-C', 'timeFrame': '3 days post-trauma'}, {'measure': 'Cystatin-C-based mean estimated glomerular filtration rate', 'timeFrame': '3 days post-trauma'}, {'measure': 'AKIN stages', 'timeFrame': '7 days post-trauma'}, {'measure': 'Highest AKIN stage reached on each day during the first week', 'timeFrame': '7 days post-trauma'}, {'measure': 'RIFLE stages', 'timeFrame': '7 days post-trauma'}, {'measure': 'Urine output (if available)', 'timeFrame': '7 days post-trauma'}, {'measure': 'Days on Renal Replacement Therapy', 'timeFrame': '90 days after randomization'}, {'measure': 'Patients on Renal Replacement Therapy', 'timeFrame': '90 days after randomization'}, {'measure': 'Platelet count', 'timeFrame': '3 days post-trauma'}, {'measure': 'International normalized ratio', 'timeFrame': '3 days post-trauma'}, {'measure': 'Activated partial thromboplastin time', 'timeFrame': '3 days post-trauma'}, {'measure': 'Adverse Events', 'timeFrame': '90 days after randomization'}, {'measure': 'Mortality', 'timeFrame': '90 days after randomization'}, {'measure': 'Length of Stay in ICU/hospital', 'timeFrame': '90 days after randomization'}, {'measure': 'C-reactive protein', 'timeFrame': '3 days post-trauma'}, {'measure': 'Hours on mechanical ventilation', 'timeFrame': '7 days post-trauma'}, {'measure': 'Total volume of administered investigational products', 'timeFrame': 'until 24 hours after investigational product treatment start'}, {'measure': 'Fluid balance', 'timeFrame': '7 days post-trauma', 'description': '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'}, {'measure': 'Heart rate', 'timeFrame': '7 days post-trauma'}, {'measure': 'Temperature', 'timeFrame': '7 days post-trauma'}, {'measure': 'Mean arterial pressure', 'timeFrame': '7 days post-trauma'}, {'measure': 'Systolic arterial blood pressure', 'timeFrame': '7 days post-trauma'}, {'measure': 'Diastolic arterial blood pressure', 'timeFrame': '7 days post-trauma'}, {'measure': 'Central venous pressure (if available)', 'timeFrame': '7 days post-trauma'}, {'measure': 'Partial pressure of carbon dioxide', 'timeFrame': '3 days post-trauma'}, {'measure': 'Partial pressure of oxygen', 'timeFrame': '3 days post-trauma'}, {'measure': 'Bicarbonate', 'timeFrame': '3 days post-trauma'}, {'measure': 'Arterial oxygen saturation', 'timeFrame': '3 days post-trauma'}, {'measure': 'Hemoglobin', 'timeFrame': '3 days post-trauma'}, {'measure': 'Hematocrit', 'timeFrame': '3 days post-trauma'}, {'measure': 'pH', 'timeFrame': '3 days post-trauma'}, {'measure': 'Base excess', 'timeFrame': '3 days post-trauma'}, {'measure': 'Lactate', 'timeFrame': '3 days post-trauma'}, {'measure': 'Central venous oxygen saturation (if available)', 'timeFrame': '3 days post-trauma'}, {'measure': 'Serum sodium', 'timeFrame': '3 days post-trauma'}, {'measure': 'Serum potassium', 'timeFrame': '3 days post-trauma'}, {'measure': 'Serum calcium', 'timeFrame': '3 days post-trauma'}, {'measure': 'Serum chloride', 'timeFrame': '3 days post-trauma'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hydroxyethyl starch', 'HES', 'HES 130'], 'conditions': ['Hypovolemia Due to Acute Blood Loss']}, 'referencesModule': {'references': [{'pmid': '35655234', 'type': 'DERIVED', 'citation': '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': '30017128', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion:\n\n* 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)\n* Patients with blunt or penetrating trauma suffering from estimated blood loss of ≥ 500 ml\n* Initial surgery deemed necessary within 24 hrs after trauma\n* Deferred signed written informed consent form or as locally required\n* No signs of intracranial or cerebral hemorrhage\n* Administration of less than 15 ml/kg body weight colloid between trauma injury and hospital admission.\n\nExclusion:\n\n* Hypersensitivity to the active substances or to any of the other excipients of the Investigational Products\n* Body weight ≥ 140 kg\n* Patients expected to die within 24h after traumatic injury\n* Sepsis\n* Burns\n* Renal impairment (AKIN stage ≥ 1 or chronic) or acute and/or chronic Renal Replacement Therapy\n* Critically ill patients (typically admitted to the intensive care unit)\n* Hyperhydration\n* Pulmonary edema\n* Dehydration\n* Hyperkalemia\n* Severe hypernatremia\n* Severe hyperchloremia\n* Severely impaired hepatic function\n* Congestive heart failure\n* Severe coagulopathy\n* Organ transplant patients\n* Metabolic alkalosis\n* Simultaneous participation in another interventional clinical trial (drugs or medical devices studies)'}, 'identificationModule': {'nctId': 'NCT03338218', 'acronym': 'TETHYS', 'briefTitle': 'Safety and Efficacy of a 6% Hydroxyethyl Starch (HES) Solution Versus an Electrolyte Solution in Trauma Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fresenius Kabi'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'HC-G-H-1505'}, 'secondaryIdInfos': [{'id': 'HE06-021-CP4', 'type': 'OTHER', 'domain': 'Fresenius Kabi'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Volulyte 6%', 'description': 'Volulyte 6% solution for infusion', 'interventionNames': ['Drug: Volulyte 6%']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ionolyte', 'description': 'Ionolyte solution for infusion', 'interventionNames': ['Drug: Ionolyte']}], 'interventions': [{'name': 'Volulyte 6%', 'type': 'DRUG', 'otherNames': ['Hydroxyethyl starch 130'], 'description': 'Solution for infusion', 'armGroupLabels': ['Volulyte 6%']}, {'name': 'Ionolyte', 'type': 'DRUG', 'otherNames': ['Ionolyte Electrolyte Solution'], 'description': 'Solution for infusion', 'armGroupLabels': ['Ionolyte']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Genk', 'country': 'Belgium', 'facility': 'Ziekenhuis Oost-Limburg-ZOL', 'geoPoint': {'lat': 50.965, 'lon': 5.50082}}, {'city': 'Brno', 'country': 'Czechia', 'facility': 'Fakultni nemocnice Brno', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'city': 'Prague', 'country': 'Czechia', 'facility': 'Military University Hospital', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Nancy', 'country': 'France', 'facility': 'CHRU Nancy - Hôpital Central', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'city': 'Strasbourg', 'country': 'France', 'facility': 'Hôpital de Hautepierre', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'city': 'Aachen', 'country': 'Germany', 'facility': 'Universitätsklinikum Aachen', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'city': 'Dresden', 'country': 'Germany', 'facility': 'Universitätsklinikum Carl Gustav Carus Dresden', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Universitätsklinikum Frankfurt', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'city': 'Kiel', 'country': 'Germany', 'facility': 'University Hospital Schleswig-Holstein Campus Kiel', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Academic Medical Center (AMC) Anesthesiology', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'University Medical Center (UMC) Maastricht', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}, {'city': 'Cape Town', 'country': 'South Africa', 'facility': 'Groote Schuur Hospital', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'city': 'Germiston', 'country': 'South Africa', 'facility': 'Gama Research Centre Emergency Department, Leratong Hospital', 'geoPoint': {'lat': -26.23481, 'lon': 28.17665}}, {'city': 'Germiston', 'country': 'South Africa', 'facility': 'Gama Research Centre', 'geoPoint': {'lat': -26.23481, 'lon': 28.17665}}, {'city': 'Johannesburg', 'country': 'South Africa', 'facility': 'Chris Hani Baragwanath Hospital', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'city': 'Kimberley', 'country': 'South Africa', 'facility': 'Trident Clinical, Homestead Medical Centre', 'geoPoint': {'lat': -28.73226, 'lon': 24.76232}}, {'city': 'Pretoria', 'country': 'South Africa', 'facility': 'Steve Biko Academic Hospital', 'geoPoint': {'lat': -25.74486, 'lon': 28.18783}}, {'city': 'Vereeniging', 'country': 'South Africa', 'facility': 'FCRN Clinical Trials Centre', 'geoPoint': {'lat': -26.67313, 'lon': 27.92615}}, {'city': 'Worcester', 'country': 'South Africa', 'facility': 'Clinical Projects Research SA', 'geoPoint': {'lat': -33.64651, 'lon': 19.44852}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Gregorio Marañón', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Clinico Universitario', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Universitari i Politecnic la Fe', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': 'Wolfgang F. Buhre, Prof. Dr. med.', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Anesthesiology and Pain Management, Maastricht University, The Netherlands'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fresenius Kabi', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'B. Braun Melsungen AG', 'class': 'INDUSTRY'}, {'name': 'European Society of Anaesthesiology and Intensive Care', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}