Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-02-23 @ 9:22 PM
Study NCT ID:
NCT06279793
Status:
RECRUITING
Last Update Posted:
2025-04-30
First Post:
2023-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intravenous Fish Oil Based Lipid Emulsion to Enhance Recovery in High-Risk Cardiac Surgery Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005395', 'term': 'Fish Oils'}, {'id': 'C568345', 'term': 'fish oil triglycerides'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D009821', 'term': 'Oils'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Patients as well as clinical staff and outcome assessors not involved in the study will be blinded to study intervention allocation.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomization will be stratified by site, employing a web-based system using a 1:1 ratio to either intravenous fish oil-based lipid emulsion (Omegaven®), or placebo.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-28', 'studyFirstSubmitDate': '2023-09-13', 'studyFirstSubmitQcDate': '2024-02-19', 'lastUpdatePostDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Optional tertiary endpoint: Ultrasound measurement of thigh skeletal muscle mass', 'timeFrame': 'Screening (preoperative day -7 until day -1), ICU discharge (approximately 3-4 days after surgery), hospital discharge (approximately 1-2 weeks after surgery)', 'description': 'Ultrasound measurement of thigh skeletal muscle mass'}, {'measure': 'Optional tertiary endpoint: Functional Status Score for Intensive Care Unit (FSS-ICU)', 'timeFrame': 'Screening (preoperative day -7 until day -1), ICU discharge (approximately 3-4 days after surgery), hospital discharge (approximately 1-2 weeks after surgery)', 'description': 'Functional Status Score for Intensive Care Unit (FSS-ICU)'}, {'measure': 'Optional tertiary endpoint: Short Physical Performance Battery test (SPPB)', 'timeFrame': 'Screening (preoperative day -7 until day -1), ICU discharge (approximately 3-4 days after surgery), hospital discharge (approximately 1-2 weeks after surgery)', 'description': 'Short Physical Performance Battery test (SPPB)'}, {'measure': 'Optional tertiary endpoint: Hand grip/held dynamometer', 'timeFrame': 'Screening (preoperative day -7 until day -1), ICU discharge (approximately 3-4 days after surgery), hospital discharge (approximately 1-2 weeks after surgery)', 'description': 'Hand grip/held dynamometer'}, {'measure': 'Optional tertiary endpoint: Inflammatory response', 'timeFrame': 'Intraoperative day 0, postoperative days 0-7', 'description': 'Inflammatory response and immune function as measured by markers of the clinical routine (e.g. IL6, IL10, CRP, white blood cell count \\[WBC\\], PCT, TNF-a)'}, {'measure': 'Optional tertiary endpoint: Left ventricular ejection fraction', 'timeFrame': 'Preoperative day -1, hospital discharge (approximately 1-2 weeks after surgery), day 30 follow-up, 3 and 6 months follow-up', 'description': 'Left ventricular ejection fractLeft ventricular ejection fractionion'}, {'measure': 'Optional tertiary endpoint: Manual Muscle Testing (MMT)', 'timeFrame': 'Screening (preoperative day -7 until day -1), ICU discharge (approximately 3-4 days after surgery), hospital discharge (approximately 1-2 weeks after surgery)', 'description': 'Manual Muscle Testing (MMT)'}, {'measure': 'Optional tertiary endpoint: Vasoactive-Inotropic Score (VIS)', 'timeFrame': 'Postoperative days 0-7', 'description': 'Vasoactive-Inotropic Score (VIS)'}, {'measure': 'Optional tertiary endpoint: Therapeutic Intervention Scoring System (TISS)', 'timeFrame': 'Postoperative days 0-7', 'description': 'A method for measuring workload and calculating costs in the ICU'}, {'measure': 'Optional tertiary endpoint: Development of delirium', 'timeFrame': 'Postoperative days 0-7', 'description': 'Assessed by the CAM ICU score'}, {'measure': 'Optional tertiary endpoint: Hemodynamic parameters', 'timeFrame': 'Intraoperative day 0, postoperative days 0-7', 'description': 'Adequate hemodynamic support, as defined by stable Cardiac Index, cardiac output (CO), Cardiac Power Index, mean arterial pressure (MAP), central vein pressure (CVP), pulmonary artery diastolic pressure (to be measured every 8 hours for first 72 hours post-op or until removal of pulmonary artery catheter, whatever comes first'}, {'measure': 'Optional tertiary endpoint: Clinical frailty scale', 'timeFrame': 'Screening (preoperative day -1 until day -7), day 30 follow-up, 3 months follow-up', 'description': 'A 9-point scale that quantifies frailty based on function in individual patients'}, {'measure': 'Optional tertiary endpoint: Simplified Acute Physiology Score (SAPS)', 'timeFrame': 'Postoperative days 0-7', 'description': 'Estimates the probability of mortality for ICU patients on admission'}, {'measure': 'Optional tertiary endpoints: Further routine biomarkers', 'timeFrame': 'Intraoperative day 0, postoperative days 0-7', 'description': 'Further routine biomarkers: creatinine, urea, bilirubin, troponin, triglycerides if available'}, {'measure': 'Separate Sub-study', 'timeFrame': 'Preoperative day -1, intraoperative day 0, postoperative days 0-7, hospital discharge (approximately 1-2 weeks after surgery)', 'description': 'Serial blood samples and - if available - tissue samples from patients (if these result from the routine surgical procedure) will be collected in concerning patients at the day before (only blood samples), during surgery (only tissue sample if available), and once daily after surgery while the patients are on ICU (only blood samples):\n\n* Specialized pro-resolving mediators (SPMs) and more specific markers of the inflammatory response, such as the production of leukotriene B5 (LTB5), leukotriene B4 (LTB4), 5-hydroxyeicosapentaenoic acid (5-HEPE) and production of 5-hydroxyeicosatetraenoic acid (5-HETE)\n* SPMs, such as maserins and resolvins\n* Oxidative stress (oxidative reduction potential, Malondialdehyde)\n* Membrane incorporation of PUFAs (white blood cells) \\&amp;amp;amp; tissue samples\n* Activation of survival kinases (such as extracellular-signal regulated'}], 'primaryOutcomes': [{'measure': 'Atrial fibrillation', 'timeFrame': 'Postoperative days 0-7', 'description': 'The primary objective is to demonstrate superiority of fish oil compared to placebo in the prevention of atrial fibrillation until 7 days after surgery. This clinical endpoint is assessed as part of the clinical practice.'}], 'secondaryOutcomes': [{'measure': 'Mechanical ventilation', 'timeFrame': 'Postoperative days 0-7, ICU discharge (approximately 3-4 days after surgery), hospital discharge (approximately 1-2 weeks after surgery), day 30 follow-up', 'description': 'Duration of mechanical ventilation'}, {'measure': 'Adverse Events', 'timeFrame': 'Preoperative day -1 to 12 months follow-up', 'description': 'AEs leading to discontinuation/AEs at least possibly related to the IMP/SAEs'}, {'measure': 'Delta Sequential Organ Failure Assessment Score (SOFA) Score', 'timeFrame': 'Postoperative days 0-7', 'description': 'A scoring system that assesses the performance of several organ systems in the body (neurologic, blood, liver, kidney, and blood pressure/hemodynamics) and assigns a score based on the data obtained in each category.'}, {'measure': 'Stroke', 'timeFrame': 'Postoperative days 0-7', 'description': 'Incidence of stroke'}, {'measure': 'Inotropics/vasopressors', 'timeFrame': 'Postoperative days 0-7, ICU discharge (approximately 3-4 days after surgery), hospital discharge (approximately 1-2 weeks after surgery), day 30 follow-up', 'description': 'Duration of inotropic/vasopressor support'}, {'measure': 'Acute Kidney Injury', 'timeFrame': 'Postoperative days 0-7', 'description': 'Kidney Disease: Improving Global Outcomes \\[KDIGO\\] stages 1-3'}, {'measure': 'Infection rate', 'timeFrame': 'Postoperative days 0-7', 'description': 'Number of infections'}, {'measure': 'Survival status', 'timeFrame': 'ICU discharge (approximately 3-4 days after surgery), hospital discharge (approximately 1-2 weeks after surgery), day 30 follow-up, months 3, 6, and 12 follow-up', 'description': 'Overall survival'}, {'measure': 'Quality of Life (SF-36)', 'timeFrame': 'Screening (preoperative day -7 until day -1), day 30 follow-up, 3, 6, and 12 months follow-up', 'description': 'To measure the quality of life'}, {'measure': 'Postoperative bleeding', 'timeFrame': 'Postoperative days 0-7', 'description': 'Bleeding after surgery'}, {'measure': 'ICU length of stay', 'timeFrame': 'ICU discharge (approximately 3-4 days after surgery)', 'description': 'Number of days alive in the ICU'}, {'measure': 'Hospital length of stay', 'timeFrame': 'Hospital discharge (approximately 1-2 weeks after surgery)', 'description': 'Number of days alive in the hospital'}, {'measure': 'Physical activity assessment', 'timeFrame': 'Screening (preoperative day -7 until day -1), day 30 follow-up, 3 and 6 months follow-up', 'description': "Katz activities of daily living (ADL) and Lawton's Instrumental ADL (IADL)"}, {'measure': 'Days alive and out of hospital', 'timeFrame': 'Day 30 follow-up, 3, 6, and 12 months follow-up', 'description': 'Time to be alive and discharge from hospital'}, {'measure': 'Time to discharge alive', 'timeFrame': 'ICU discharge (approximately 3-4 days after surgery), hospital discharge (approximately 1-2 weeks after surgery)', 'description': 'Time to be alive and discharged from ICU/hospital'}, {'measure': 'Weaning from cardiopulmonary bypass (CPB)', 'timeFrame': 'Intraoperative day 0 (during surgery)', 'description': 'Number of attempts to wean from CPB during surgery'}, {'measure': 'Persistent Organ Dysfunction + Death', 'timeFrame': 'Postoperative days 0-7, ICU discharge (approximately 3-4 days after surgery), hospital discharge (approximately 1-2 weeks after surgery), day 30 follow-up', 'description': 'Requiring supportive technologies during the convalescent phase of critical illness'}, {'measure': 'ICU Readmission rates', 'timeFrame': 'Day 30 follow-up, 3, 6, and 12 months follow-up', 'description': 'Readmission to ICU'}, {'measure': 'Hospital Readmission rates', 'timeFrame': 'Day 30 follow-up, 3, 6, and 12 months follow-up', 'description': 'Readmission to hospital'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['intensive care unit', 'elective cardiac surgery', 'fish oil', 'medical nutrition therapy', 'atrial fibrillation'], 'conditions': ['Intensive Care Unit', 'Coronary Artery Bypass Grafting (CABG)', 'High Risk Patients', 'Cardiopulmonary Bypass', 'Elective Cardiac Surgery', 'Valvular Heart Surgery', 'Multiple Valve Surgeries', 'Combined Cardiac Procedures', 'Aortic Surgical Procedures']}, 'descriptionModule': {'briefSummary': 'The MODIFY CSX study is a prospective, randomized, placebo-controlled trial conducted in heart centers in Germany.\n\nA total of 120 high-risk cardiac surgery patients will receive either 0.20 g fish oil/kg body weight (BW) + standard of care versus same volume of placebo (NaCl) + standard of care.', 'detailedDescription': "The proposed hypothesis is that the therapeutic strategy tested in this randomized trial will decrease the occurrence of postoperative atrial fibrillation, which ultimately leads to faster time to discharge alive. This in turn significantly improves the patients' mid and long-term outcomes and dramatically reduces associated healthcare related costs.\n\nDuration of intervention: until discharge from ICU, death or postoperative day 7 on ICU, whichever comes first.\n\nTreatment Group: Patients will receive 0.20 g fish oil/kg BW/d (≙ 2 mL Omegaven®/kg BW/d).\n\nControl Group: Patients will receive 0,9% NaCl in dose 2 mL/kg BW/d (placebo).\n\nFollow-up per patient: at day 30, months 3, 6, and 12.\n\nPrimary endpoint (Phase II study):\n\nThe primary endpoint for this phase II clinical trial is be the onset and occurence of atrial fibrillation after cardiac surgery (AFACS) until day 7 after surgery (on ICU and normal ward)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Written informed consent prior to study participation\n2. Adult patients (≥ 18 years)\n3. Patients scheduled to undergo elective cardiac surgery with the use of CPB, who are defined as high risk based on having (i) one of the following surgical procedures: valvular heart surgery only, CABG, combined valve and CABG, multiple valve surgeries, combined cardiac procedures, aortic surgical procedures (aortic arch and/or descending aorta; aortic valve+ascending aorta) and (ii) at least one of the following additional risk factors: (a) a high perioperative risk profile, defined as predicted operative mortality of ≥8% (EuroSCORE II), (b) age ≥70, (c) Clinical Frailty Score 4 or more, (d) urgent surgery (defined as to be performed within 24-48 hours after admission), (e) left ventricular ejection fraction \\<35%\n\nExclusion Criteria:\n\n1. Known hypersensitivity to fish oil/fish products or egg protein\n2. Pregnancy or lactation period\n3. Previous history of chronic atrial fibrillation, atrial flutter and/or atrial tachyarrhythmia\n4. Inability or unwillingness of individual to give written informed consent\n5. Not expected to survive an additional 48 hours from screening evaluation\n6. Lack of commitment to full, aggressive care (anticipated withholding or withdrawing treatments in the first week but isolated "Do not Resuscitate" \\[DNR\\] acceptable)\n7. Patients admitted with diabetic ketoacidosis or non-ketotic hyperosmolar coma\n8. Patients receiving extracorporeal mechanical assist device (e.g. ECLS, or IABP) or advanced heart failure therapies (e.g. TAH, VAD)\n9. Enrolment in anyinterventional trial within the last 30 days\n10. Already receiving FO-containing medical nutrition products\n11. Severe malnutrition (as defined by the BMI \\<18.5)\n12. Severe liver dysfunction defined by Child Pugh Class C.\n13. Severe chronic kidney dysfunction defined by the National Kidney Foundation (NKF) stage 4 and 5 by using the glomerular filtration rate (GFR \\<30ml/min)\n14. Known severe coagulation disorder'}, 'identificationModule': {'nctId': 'NCT06279793', 'acronym': 'MODIFY CSX', 'briefTitle': 'Intravenous Fish Oil Based Lipid Emulsion to Enhance Recovery in High-Risk Cardiac Surgery Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'GCP-Service International West GmbH'}, 'officialTitle': 'Intravenous Fish Oil Based Lipid Emulsion to Enhance Recovery in High-Risk Cardiac Surgery Patients: a Phase II Multicenter Trial - A Randomized, Placebo-controlled Trial -', 'orgStudyIdInfo': {'id': 'MODIFY CSX'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group', 'description': 'Patients will receive 0.20 g fish oil/kg BW/d (≙2 mL Omegaven®/kg BW/d).', 'interventionNames': ['Drug: Fish Oil']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Patients will receive 0,9% NaCl in volume 2 mL/kg BW/d (placebo).', 'interventionNames': ['Drug: Intravenous 0.9% Sodium Chloride']}], 'interventions': [{'name': 'Fish Oil', 'type': 'DRUG', 'otherNames': ['Omegaven®'], 'description': 'Omegaven® is a 10% fish oil emulsion with a high percentage of long-chain n-3 fatty acids - mainly eicosapentaenoic acid and docosahexaenoic acid. It optimises the fatty acid pattern in parenteral nutrition and is a source of polyunsaturated n-3 fatty acids as cell membrane components and precursors for eicosanoids.\n\nOmegaven® is manufactured by Fresenius-Kabi, Germany and is available in 100 mL bottles for study purpose.\n\nEach 100 mL of Omegaven® contains 10 g of fish oil (0.1 g/mL).\n\nTimeframe: Day -1: 0.20 g fish oil/kg BW/d (the treatment should be started 24 to 3 h before surgery, can be given as 3-6 hours infusion); intraoperative day 0: no dose; postoperative day 0: 0.20 g fish oil/kg BW/d; postoperative days 1 to max. 7): 0.20 g fish oil/kg BW/d', 'armGroupLabels': ['Treatment group']}, {'name': 'Intravenous 0.9% Sodium Chloride', 'type': 'DRUG', 'otherNames': ['Saline Infusion'], 'description': 'Intravenous 0.9% Sodium Chloride (volume 2 mL/kg BW/d) provided at the same timepoints as the intervention.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Augsburg', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Philipp Simon, Prof. Dr.', 'role': 'CONTACT', 'email': 'philipp.simon3@uk-augsburg.de', 'phone': '+49 821 400 - 2371'}, {'name': 'Manfred Weiss, Prof. Dr.', 'role': 'CONTACT', 'email': 'Manfred.Weiss@uk-augsburg.de'}, {'name': 'Philipp Simon, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital Augsburg', 'geoPoint': {'lat': 48.37154, 'lon': 10.89851}}, {'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Sascha Ott, M.D', 'role': 'CONTACT', 'email': 'sascha.ott@dhzc-charite.de', 'phone': '49-30-4593-2600'}, {'name': 'Maren Kleine-Brüggeney, M.D', 'role': 'CONTACT', 'email': 'maren.kleine-brueggeney@dhzc-charite.de'}, {'name': 'Sascha Ott, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Charité Universitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Bonn', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Maria Wittmann, M.D', 'role': 'CONTACT', 'email': 'maria.wittmann@ukbonn.de', 'phone': '49-28 287-15074-14137'}, {'name': 'Florian Piekarski, M.D', 'role': 'CONTACT', 'email': 'Florian.Piekarski@ukbonn.de'}, {'name': 'Maria Wittmann, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Bonn', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'city': 'Göttingen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Reiner Wäschle, M.D', 'role': 'CONTACT', 'email': 'Reiner.Waeschle@med.uni-goettingen.de', 'phone': '49-551-3967701'}, {'name': 'Anselm Bräuer, M.D.', 'role': 'CONTACT', 'email': 'anselm.braeuer@med.uni-goettingen.de'}, {'name': 'Reiner Waeschle, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital Goettingen', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}, {'city': 'Hamburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Bernd Saugel, Prof. Dr.', 'role': 'CONTACT', 'email': 'b.saugel@uke.de', 'phone': '+49 40 7410-52415'}, {'name': 'Ekaterina Nekhaeva, Dr.', 'role': 'CONTACT', 'email': 'e.nekhaeva@uke.de'}, {'name': 'Bernd Saugel, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital Hamburg-Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Kiel', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Elke Gunnar, M.D', 'role': 'CONTACT', 'email': 'Gunnar.Elke@uksh.de', 'phone': '49-431-500 20801'}, {'name': 'Matthias Lindner, M.D', 'role': 'CONTACT', 'email': 'Matthias.Lindner@uksh.de'}, {'name': 'Gunnar Elke, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Medical Center Schleswig-Holstein', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'city': 'Mainz', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Daniel Dürr, Prof. Dr.', 'role': 'CONTACT', 'email': 'Daniel.Duerr@unimedizin-mainz.de', 'phone': '+49 6131 17-2106'}, {'name': 'Jan Beer, Dr.', 'role': 'CONTACT', 'email': 'Jan.Beer@unimedizin-mainz.de'}, {'name': 'Daniel Dürr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital Mainz', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'city': 'Münster', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Alexander Zarbock, M.D', 'role': 'CONTACT', 'email': 'zarbock@uni-muenster.de', 'phone': '49-251-83-44017'}, {'name': 'Melanie Meersch-Dini, M.D', 'role': 'CONTACT', 'email': 'meersch@ukmuenster.de'}, {'name': 'Alexander Zarbock, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital Muenster', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}], 'centralContacts': [{'name': 'Christian Stoppe, Prof. Dr.', 'role': 'CONTACT', 'email': 'cstoppe@gcp-service.com', 'phone': '49-931-20130001'}, {'name': 'Ellen Dresen, Dr.', 'role': 'CONTACT', 'email': 'Dresen_E@ukw.de', 'phone': '+49 931-201 30392'}], 'overallOfficials': [{'name': 'Christian Stoppe, Prof. Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Wuerzburg University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GCP-Service International West GmbH', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University Hospital, Bonn', 'class': 'OTHER'}, {'name': 'University Hospital Muenster', 'class': 'OTHER'}, {'name': 'University Hospital Goettingen', 'class': 'OTHER'}, {'name': 'University Hospital Schleswig-Holstein', 'class': 'OTHER'}, {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, {'name': 'Wuerzburg University Hospital', 'class': 'OTHER'}, {'name': 'Johannes Gutenberg University Mainz', 'class': 'OTHER'}, {'name': 'University Hospital Augsburg', 'class': 'OTHER'}, {'name': 'Universitätsklinikum Hamburg-Eppendorf', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}