Trial of 6% HES130/0.4

Fresenius Kabi

Status and phase: Completed; Phase 3

Conditions: Hemorrhage; Hypovolemia

Treatments: Drug: 6% hydroxyethyl starch 130/0.4; Drug: 6% hydroxyethyl starch 70/0.5 (Salinhes®)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01010022

HS-13-02-JP

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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64 participants in 2 patient groups

1

Experimental group

Description:

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

Treatment:

Drug: 6% hydroxyethyl starch 130/0.4

2

Active Comparator group

Description:

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

Treatment:

Drug: 6% hydroxyethyl starch 70/0.5 (Salinhes®)