Clinical trials: Hydroxyethyl Starch
Laparoscopy, Tissue Adhesion, Surgery-Induced
The Efficacy and Safety of Medicurtain® in Patients With Total Laparoscopic Hysterectomy (Pivotal Study)
This study was designed to assess the safety and efficacy of MEDICURTAIN. Patients who underwent total laparoscopic hysterectomy were randomly assigned either into Medicurtain® treatment group or non-treatment control group.
- Conditions
- Laparoscopy, Tissue Adhesion, Surgery-Induced, Leiomyoma of the Uterine Body
- Trial name
- NCT04672421
- Testing
- Medicurtain®
- Where
- South Korea
- Volunteers
- 107 people
- Sponsor
- Shin Poong Pharmaceutical Co. Ltd.
Postoperative Complications
Study to Evaluate the Effect of Hydroxyethyl Starch (HES) in Complications of Patients After Abdominal Surgery
Purpose: To compare the incidence of post-surgery complications and evaluate relevant parameters within 28 days after an operation in HES (130/0.4) and albumin treated groups Study Design: Open-label, active controlled, parallel…
- Trial name
- NCT00308126
- Testing
- Hydroxyethyl Starch 130/0.4 (Voluven)
- Where
- China
- Volunteers
- 624 people
- Sponsor
- Fresenius Kabi
Hypovolaemia Due to Acute Blood Loss
Safety and Efficacy of 6% Hydroxyethyl Starch (HES) Solution Versus an Electrolyte Solution in Patients Undergoing Elective Abdominal Surgery
The aim of the study is to investigate the safety of a 6% HES (Hydroxyethyl Starch) solution (Volulyte 6%) versus an electrolyte solution (Ionolyte) in patients undergoing elective abdominal surgery.
- Trial name
- PHOENICS (NCT03278548)
- Testing
- Volulyte 6%, Ionolyte
- Where
- 61 sites in Austria, Belgium and 8 more
- Volunteers
- 2,289 people
- Sponsor
- Fresenius Kabi
Hypovolemia, Hemorrhage
Trial of 6% HES130/0.4
The study shall evaluate the efficacy and safety of two different hydroxyethyl starch solutions (artificial colloids 6% HES130/0.4 and 6% HES70/0.5, Salinhes®) for intra-operative therapy of hypovolemia and maintenance of…
- Trial name
- NCT01010022
- Testing
- 6% hydroxyethyl starch 130/0.4, 6% hydroxyethyl starch 70/0.5 (Salinhes®)
- Where
- 7 sites in Japan
- Volunteers
- 64 people
- Sponsor
- Fresenius Kabi Japan
Plasma Volume Replacement, Surgery of the Pancreatic Head
Plasma Volume Replacement (PVR) Therapy With Colloid and Crystalloid Solutions
The purpose of this study is to investigate the efficacy of target controlled fluid therapy with a hyper-oncotic balanced HES solution compared to an iso-oncotic HES solution in patients undergoing elective surgery of the…
- Trial name
- NCT01117649
- Testing
- HES 10%, HES 6%, balanced electrolyte solution
- Where
- 3 sites in Germany
- Volunteers
- 63 people
- Sponsor
- B. Braun Melsungen AG
Hypotension, Ischemia
Phase III Study of Hemospan® for Treating Hypotension in Hip Arthroplasty
The purpose of this study is to determine whether Hemospan is superior to Voluven for treatment of hypotensive episodes during the perioperative period (from induction of spinal anesthesia until 6 hours after skin closure), and…
- Trial name
- NCT00420277
- Testing
- Hemospan (MP4OX), Voluven (HES 130/0.4)
- Where
- 22 sites in Belgium, Czechia and 3 more
- Volunteers
- 462 people
- Sponsor
- Sangart
Cardiac Surgery, Cardiopulmonary Bypass
Voluven® in Paediatric Patients
This study will compare the clinical efficacy and safety of Voluven® and Human Albumin during elective open-heart surgery in pediatric patients.
- Trial name
- NCT00860405
- Testing
- HES 130/0.4 (6%) in sodium chloride (Voluven®, solution for infusion), Human serum albumin (HSA 50g/L), Human serum albumin (HSA 50g/L)
- Where
- 2 sites in Austria, Belgium
- Volunteers
- 61 people
- Sponsor
- Fresenius Kabi
Intervertebral Disc Disorder, Thoracic Intervertebral Disc Disorders
Spine Surgery for Adhesions in Patients Evaluated for Efficacy and Safety of MedicurtainⓇ (Pivotal Study)
This study was designed to evaluate the efficacy and safety of Medicurtain®, an antiadhesion barrier in patients who underwent In Situ Decompression for single level and unilateral herniated lumbar intervertebral disc.
- Conditions
- Intervertebral Disc Disorder, Thoracic Intervertebral Disc Disorders, Thoracolumbar Intervertebral Disc Disorders, Lumbosacral Intervertebral Disc Disorders
- Trial name
- NCT04688281
- Testing
- Medicurtain®, GUARDIX-SG®
- Where
- South Korea
- Volunteers
- 87 people
- Sponsor
- Shin Poong Pharmaceutical Co. Ltd.
Hypotension, Ischemia
Phase III Study of Hemospan® to Prevent Hypotension in Hip Arthroplasty
The purpose of this study is to determine whether Hemospan is superior to Voluven for preventing hypotensive episodes during the perioperative period (from induction of spinal anesthesia until 6 hours after skin closure), and for…
- Trial name
- NCT00421200
- Testing
- Hemospan (MP4OX), Voluven (HES 130/0.4)
- Where
- 18 sites in Belgium, Czechia and 4 more
- Volunteers
- 375 people
- Sponsor
- Sangart
Plasma Volume Replacement
Safety Profile of Hydroxyethyl Starch
The study is primarily aimed to collect further data on the safety of the investigational product in a large patient population when used in routine clinical practice in the Asian-Pacific region.
- Trial name
- NCT01304433
- Testing
- Venofundin 6% / Tetraspan 6%
- Where
- 6 sites in China, Malaysia
- Volunteers
- 1,000 people
- Sponsor
- B. Braun Melsungen AG
Heart; Dysfunction Postoperative, Cardiac Surgery
VolulyteTM in Cardiac Surgery
The study will compare the efficacy and safety of VolulyteTM and human albumin in elective open-heart surgery in adult patients.
- Trial name
- NCT01553617
- Testing
- 6% hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution (VolulyteTM), Human serum albumin
- Where
- 5 sites in Canada
- Volunteers
- 133 people
- Sponsor
- Fresenius Kabi
Decreased and Nonspecific Blood Pressure Disorders and Shock
Comparison of HES 130 in Balanced and in Unbalanced Solution
The purpose of this study is to evaluate the efficacy of HES 130/0.42 in an electrolyte infusion in comparison to HES 130/0.4 in a sodium chloride infusion.
- Trial name
- NCT01301469
- Testing
- 6% HES 130/0.42 in plasma adapted Ringer's solution, 6% HES 130/0.4 in a saline solution
- Where
- 4 sites in China
- Volunteers
- 240 people
- Sponsor
- B. Braun Melsungen AG
Coronary Heart Disease
Efficacy and Safety of Hypertonic Sodium Lactate Solution Compared With 6% HES Solution in CABG Patients
The choice of fluid therapy is controversial in cardiac surgery. Numerous studies have shown that colloid is better as compared to crystalloids.
- Trial name
- NCT01654653
- Testing
- Hypertonic sodium lactate, 6% Hydroxy Ethyl Starch
- Where
- Indonesia
- Volunteers
- 100 people
- Sponsor
- Innogene Kalbiotech Pte. Ltd
Vascular Disease, Critical Lower Limb Ischemia
Pilot Study of Hemospan® in Patients With Chronic Critical Limb Ischemia
The purpose of this study is to evaluate the effects of Hemospan infusion on vascular reactivity, regional perfusion and oxygenation of ischemic tissue in patients with chronic critical lower limb ischemia.
- Trial name
- NCT00633659
- Testing
- Hemospan (MP4OX), Voluven (HES 130/0.4)
- Where
- Sweden
- Volunteers
- 6 people
- Sponsor
- Sangart
Hypovolemia Due to Acute Blood Loss
Safety and Efficacy of a 6% Hydroxyethyl Starch (HES) Solution Versus an Electrolyte Solution in Trauma Patients
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.
- Trial name
- TETHYS (NCT03338218)
- Testing
- Volulyte 6%, Ionolyte
- Where
- 22 sites in Belgium, Czechia and 5 more
- Volunteers
- 238 people
- Sponsor
- Fresenius Kabi
Sepsis
Effects of Voluven on Hemodynamics and Tolerability of Enteral Nutrition in Patients With Severe Sepsis
The rapidity and the quality of fluid resuscitation in patients with severe sepsis are important factors for the prevention of secondary multi-organ failure.
- Trial name
- CRYSTMAS (NCT00464204)
- Testing
- 6 % Hydroxyethylstarch 130/0.4 = "Voluven®", 0.9 % NaCl
- Where
- 24 sites in France, Germany
- Volunteers
- 196 people
- Sponsor
- Fresenius Kabi
Plasma Volume Substitution (Hypovolemia) Including Massive Hemorrhage
Study to Obtain Volume Effect and Safety Data on 6 % Hydroxyethyl Starch 130/0.4 in Pediatric and Adult Patients Undergoing Major Elective Surgery
The study shall evaluate the volume effect and safety of 6 % hydroxyethyl starch 130/0.4 for restoration and maintenance of hemodynamics during the investigational period in patients undergoing major elective surgery.
- Trial name
- NCT01127477
- Testing
- 1: Hydroxyethyl starch 130/0.4, 6 %
- Where
- 4 sites in Japan
- Volunteers
- 20 people
- Sponsor
- Fresenius Kabi Japan
Hypotension
Efficacy of Voluven® for the Prevention of Hypotension During Spinal Anesthesia for Cesarean Section
The aim of the study is to evaluate the efficacy of Voluven® in the prevention of maternal hypotension in women undergoing spinal anesthesia for cesarean section
- Trial name
- CAESAR (NCT00694343)
- Testing
- HES 130/0.4 (6%) in sodium chloride (solution for infusion), Ringer's Lactate solution
- Where
- 14 sites in France
- Volunteers
- 167 people
- Sponsor
- Fresenius Kabi
Intraoperative Complications
Hydroxyethyl Starch (130/0.4) for Intravascular Volume Therapy in Liver Transplantation
There are no standardized plasma volume replacement protocols during liver transplantation surgery. The current study is designed to compare efficacy, safety, and costs of perioperative volume replacement with Voluven…
- Trial name
- NCT00308100
- Testing
- Hydroxyethylstarch 130/0.4, 5% Albumin
- Where
- China
- Volunteers
- 53 people
- Sponsor
- Fresenius Kabi