16 completed, 3 unknown, 2 terminated, 1 withdrawn. 9 Phase 4, 8 Not applicable, 2 Phase 2, 2 Phase 3, 1 Early Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 4 | 9 | Completed 7, Terminated 1, Unknown 1 |
| Not applicable | 8 | Completed 5, Terminated 1, Unknown 1, Withdrawn 1 |
| Phase 2 | 2 | Completed 2 |
| Phase 3 | 2 | Completed 2 |
| Early Phase 1 | 1 | Unknown 1 |
Follow Voluven: new trials by email Literature Review of Voluven trials Research Report on Voluven
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Different Preloads for Prevention of Hypotension in Patients Undergoing Elective CS Under Intrathecal Anesthesia Ringer, Voluven - Hypotension Drug-Induced | Early Phase 1 | Unknown | Assiut University | 60 | 2018-03-01 | 2018-03-15 |
| Fluid Optimization With Crystalloids and Colloids in Neurosurgery Sterofundin (Bolus of crystalloids), Voluven (Bolus of colloids) - Postoperative Complications | Not applicable | Completed | University Medical Centre Ljubljana | 80 | 2017-01-01 | 2021-09-16 |
| Colloid Pre-Loading on D-Dimer During Cesarean Section Under Spinal Anesthesia hydroxyethyl starch (6% 130/0.4), Hyperbaric bupivacaine, Morphine - Coagulation Defect; Bleeding | Phase 2 | Completed | Assiut University | 60 | 2016-01-01 | 2016-11-08 |
| Goal-Directed Intraoperative Fluid Management Using FloTrac© Monitoring in High-Risk Neurosurgical Patients Phenylephrine, Epinephrine, Albumin - Intracranial Aneurysm, Brain Edema | Not applicable | Completed | NYU Langone Health | 66 | 2014-03-01 | 2019-08-28 |
| Comparison of Priming Constituents in Patients Undergoing CPB Assisted Cardiac Surgery: HES 130/0.4 or Albumin 5% prime crystalloid, Human Albumin, Voluven - Coronary Artery Disease, Aortic Valve Disease | Not applicable | Withdrawn | University of Saskatchewan | 2013-11-01 | 2019-05-03 | |
| Colloids in Pediatric Cardiac Surgery: Comparison Between a Balanced and a Non-balanced Colloid Hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution, Hydroxyethyl starch 130/0.4 in 0.9% sodium chloride - Cardiac Surgery, Cardiopulmonary Bypass | Phase 3 | Completed | Queen Fabiola Children's University Hospital | 88 | 2013-02-15 | 2020-11-09 |
| Hydroxyethyl Starch and Renal Function After Radical Prostatectomy Voluven (Hydroxyethyl starch 130/0,4), Sodium Chloride 9 mg/ml - Prostate Cancer | Phase 4 | Completed | Regional Hospital Holstebro | 40 | 2012-01-01 | 2013-09-17 |
| Hydroxyethyl Starch and Renal Function After Hip Replacement Surgery Voluven (Hydroxyethyl starch 130/0,4), Sodium Chloride 9 mg/ml - Osteoarthritis | Phase 4 | Completed | Regional Hospital Holstebro | 42 | 2012-01-01 | 2013-05-29 |
| Hydroxyethyl Starch and Renal Function After Laparoscopic Nephrectomy Voluven (Hydroxyethyl starch 130/0,4), Sodium Chloride 9mg/ml - Kidney Cancer | Phase 4 | Terminated | Regional Hospital Holstebro | 14 | 2011-12-01 | 2014-10-09 |
| Liberal Versus Restrictive Transfusion During Symptomatic Moderate Anemia After Hip Arthroplasty Red blood cell transfusion, Voluven - Arthroplasty, Hip | Not applicable | Terminated | Copenhagen University Hospital, Rigshospitalet | 5 | 2011-10-01 | 2015-03-06 |
| ED50 Determination of Hydroxyethylstarch for Treatment of Hypotension During Cesarean Section Under Spinal Anesthesia Hydroxyethylstarch 130/0.4 - Obstetric Anesthesia, Spinal Anesthesia | Phase 4 | Unknown | Maisonneuve-Rosemont Hospital | 30 | 2011-10-01 | 2013-02-15 |
| Effect of Goal-directed Crystalloid Versus Colloid Administration on Major Postoperative Morbidity Crystalloid, Colloid - Postoperative Complications | Not applicable | Completed | The Cleveland Clinic | 1102 | 2010-11-01 | 2018-10-30 |
| Volume Kinetics for Starch Solution and Acetated Ringers acetated Ringers, colloid, colloid+acetated Ringer - Blood Volume, Blood Coagulation | Not applicable | Completed | University Hospital, Linkoeping | 10 | 2010-08-01 | 2014-10-22 |
| Colloids in Severe Trauma tetrastarch (Voluven) - Abdominal Hypertension, Abdominal Compartment Syndrome | Phase 4 | Completed | University of the Philippines | 50 | 2009-05-01 | 2009-11-25 |
| This Study Will Compare the Effect of Starch Containing to Non-Starch Containing Intravenous Fluid on Blood Loss During Coronary Artery Bypass Graft Surgery HES (130/0.4), Ringer's Lactate - Bloodloss | Not applicable | Unknown | St. Boniface Hospital | 500 | 2008-12-01 | 2008-12-03 |
| Efficacy and Safety of Hypertonic Sodium Lactate Solution Compared With 6% HES Solution in CABG Patients Hypertonic sodium lactate, 6% Hydroxy Ethyl Starch - Coronary Heart Disease | Phase 4 | Completed | Innogene Kalbiotech Pte. Ltd | 100 | 2008-07-01 | 2012-08-01 |
| Fluid Investigation Colloid vs Crystalloid Reg. Renal Hemodynamics and Function crystalloid, colloid - Renal Impairment | Not applicable | Completed | Sahlgrenska University Hospital | 30 | 2008-04-01 | 2015-05-22 |
| Phase III Study of Hemospan® for Treating Hypotension in Hip Arthroplasty Hemospan (MP4OX), Voluven (HES 130/0.4) - Hypotension, Ischemia | Phase 3 | Completed | Sangart | 462 | 2007-02-01 | 2013-08-19 |
| Comparison Between Two Techniques of Volemic Expansion in Hip Replacement Arthroplasty Hydroxyethyl Starch, Ringer's lactate - Hip Replacement Arthroplasty | Phase 4 | Completed | University of Sao Paulo | 48 | 2006-09-01 | 2009-02-19 |
| Humanalbumin, Hydroxyethylstarch and Ringer Lactate During Cardiac Surgery volume replacement, Humanalbumin 5% - Valvular Heart Disease, Coronary Artery Disease | Phase 4 | Completed | Medical University of Vienna | 240 | 2006-03-01 | 2015-04-08 |
Showing 20 of 22. Sign in to see all of them.
Hypotension (4) · Coronary Artery Disease (2) · Hemorrhage (2) · Postoperative Complications (2) · Angina Pectoris (1) · Angina, Unstable (1) · Aortic Valve Disease (1) · Brain Edema (1) · Coronary Disease (1) · Dizziness (1) · Heart Diseases (1) · Heart Valve Diseases (1) · Hemostatic Disorders (1) · Intra-Abdominal Hypertension (1) · Intracranial Aneurysm (1)
Regional Hospital Holstebro (3) · Assiut University (2) · Biopure Corporation (1) · Copenhagen University Hospital, Rigshospitalet (1) · Innogene Kalbiotech Pte. Ltd (1) · Maisonneuve-Rosemont Hospital (1) · Medical University of Vienna (1) · NYU Langone Health (1) · Queen Fabiola Children's University Hospital (1) · Sahlgrenska University Hospital (1) · Sangart (1) · St. Boniface Hospital (1) · The Cleveland Clinic (1) · University Hospital, Basel, Switzerland (1) · University Hospital, Linkoeping (1)
Denmark (4) · Belgium (3) · Sweden (3) · Austria (2) · Canada (2) · Netherlands (2) · United States (2) · Brazil (1) · Czechia (1) · Egypt (1) · Germany (1) · Indonesia (1) · Philippines (1) · Poland (1) · Slovenia (1)
Anne Sophie P. Kancir, MD PhD (3) · Andrea Kurz, MD (1) · Christian Loubert, MD, FRCPC (1) · Cindy E Boom, PhD, MD (1) · Eva M Base, MD (1) · Jenny Skytte Larsson, MD (1) · Jo-Anne E Marcocoux, M. Sc. (1) · Jo-Anne E Marcoux, M. Sc. (1) · Joachim Zdolsek, MD, PhD (1) · Marc Bloom, MD (1) · Martin Siegemund, MD (1) · Oeivind Jans, MD (1) · P W Serruys, Professor (1) · Philippe Van der Linden, MDPhD (1)
PMID 15758080, PMID 19608488, PMID 21317165, PMID 23047301, PMID 23303244, PMID 23718743, PMID 25627076, PMID 26475802, PMID 32753064, PMID 33957864, PMID 33966019