Trial of 6% HES130/0.4

Study Overview
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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.

Official Title
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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

Conditions
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Hypovolemia, Hemorrhage

Intervention / Treatment
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* Drug: 6% hydroxyethyl starch 130/0.4
* Drug: 6% hydroxyethyl starch 70/0.5 (Salinhes®)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Up to 1000mL 6% hydroxyethyl starch 130/0.4 solution i.v., intra-operatively (from start of surgery until end of surgery) | Drug: 6% hydroxyethyl starch 130/0.4<br>* Up to 1000mL 6% hydroxyethyl starch 130/0.4 solution i.v., intra-operatively (from start of surgery until end of surgery)<br>|
| Active Comparator: 2<br>Up to 1000mL 6% hydroxyethyl starch 70/0.5 (Salinhes®) solution i.v., intra-operatively (from start of surgery until end of surgery) | Drug: 6% hydroxyethyl starch 70/0.5 (Salinhes®)<br>* Up to 1000mL 6% hydroxyethyl starch 70/0.5 (Salinhes®) solution i.v., intra-operatively (from start of surgery until end of surgery)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume of colloid solution infused during investigational period (= intra-operatively) |  | Intra-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluid input |  | From immediately before induction of anesthesia until 48 hours after end of surgery | 
| Fluid output |  | From immediately before induction of anesthesia until 48 hours after end of surgery | 
| Fluid balance |  | From immediately before induction of anesthesia until 48 hours after end of surgery | 
| Hemodynamics |  | From immediately before induction of anesthesia until 48 hours after end of surgery | 
| Co-administration of vasoactive drugs |  | From enrolment until 48 hours after end of surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypovolemia, surgical blood loss, orthopedic procedures, Treatment of reduced circulating blood volume (hypovolemia) including massive hemorrhage