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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01010022
Other study ID # HS-13-02-JP
Secondary ID
Status Completed
Phase Phase 3
First received November 6, 2009
Last updated March 9, 2011
Start date November 2009
Est. completion date November 2010

Study information

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

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
6% hydroxyethyl starch 130/0.4
Up to 1000mL 6% hydroxyethyl starch 130/0.4 solution i.v., intra-operatively (from start of surgery until end of surgery)
6% hydroxyethyl starch 70/0.5 (Salinhes®)
Up to 1000mL 6% hydroxyethyl starch 70/0.5 (Salinhes®) solution i.v., intra-operatively (from start of surgery until end of surgery)

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Fresenius Kabi Japan

Country where clinical trial is conducted

Japan, 

Outcome

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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