Trial of 6% HES130/0.4

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypovolemia Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

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

Group Type EXPERIMENTAL

6% hydroxyethyl starch 130/0.4

Intervention Type DRUG

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

2

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

Group Type ACTIVE_COMPARATOR

6% hydroxyethyl starch 70/0.5 (Salinhes®)

Intervention Type DRUG

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

Interventions

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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)

Intervention Type DRUG

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)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No