Hemorrhage Clinical Trial
Official title:
Examination of Safety and Efficacy of 6% Hydroxyethyl Starch 130/0.4 vs. 6% Hydroxyethyl Starch 70/0.5 in Patients Undergoing Orthopedic Surgery - a Double-blind, Parallel Group, Comparative, Multi-centre Phase III Study
Verified date | March 2011 |
Source | Fresenius Kabi |
Contact | n/a |
Is FDA regulated | No |
Health authority | Japan: Pharmaceuticals and Medical Devices Agency |
Study type | Interventional |
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 circulating blood volume in patients undergoing orthopedic surgery. The primary efficacy endpoint will be the required volume of colloid solution infused from start until end of surgery. It is the aim of the clinical trial to demonstrate that comparable volumes of colloid solution are used between treatment groups.
Status | Completed |
Enrollment | 64 |
Est. completion date | November 2010 |
Est. primary completion date | July 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years and older |
Eligibility |
Inclusion Criteria: - Patients with an expected blood loss of = 300 mL undergoing elective orthopedic surgery - Patients with a body weight (BW) = 50 kg Exclusion Criteria: - Known or suspected allergy to hydroxyethyl starch, including its ingredients (inclusive corn) and related drugs - ASA classification = IV - Renal disease (serum creatinine = 2mg/dL) - Known bleeding disorders - Congestive heart failure - Fluid overload - Intracranial bleeding - Severe hypernatremia - Severe hyperchloremia |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Japan | Kyushu University, Graduate School of Medical Sciences | Fukuoka | |
Japan | Kobe University Graduate School of Medicine | Kobe | |
Japan | Okayama University | Okayama | |
Japan | Osaka University Graduate School of Medicine | Osaka | |
Japan | Sapporo Medical University, School of Medicine | Sapporo | Hokkaido |
Japan | Keio University School of Medicine | Tokyo | |
Japan | Tokyo Women's Medical University | Tokyo |
Lead Sponsor | Collaborator |
---|---|
Fresenius Kabi Japan |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Volume of colloid solution infused during investigational period (= intra-operatively) | Intra-operatively | No | |
Secondary | Fluid input | From immediately before induction of anesthesia until 48 hours after end of surgery | No | |
Secondary | Fluid output | From immediately before induction of anesthesia until 48 hours after end of surgery | No | |
Secondary | Fluid balance | From immediately before induction of anesthesia until 48 hours after end of surgery | No | |
Secondary | Hemodynamics | From immediately before induction of anesthesia until 48 hours after end of surgery | No | |
Secondary | Co-administration of vasoactive drugs | From enrolment until 48 hours after end of surgery | No |
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