[Haemaccel 35: adverse reactions in a multicentric, prospective study].

Area of Science:

• Pharmacology
• Anesthesiology
• Immunology

Context:

• Polygeline (Haemaccel 35 Behringwerke) is a plasma volume expander used in clinical settings.
• Assessing the safety profile of Polygeline is crucial due to its widespread application.
• Previous concerns regarding anaphylactoid reactions necessitated further investigation.

Purpose:

• To evaluate the incidence and type of systemic anaphylactoid and cutaneous anaphylactoid side effects associated with Polygeline.
• To assess the safety of an improved Polygeline preparation in a large patient cohort.
• To quantify histamine liberation levels in patients experiencing adverse reactions.

Summary:

• A prospective, multicentre study involving 1147 patients investigated Polygeline's side effects.
• Only 8 patients (0.78%) exhibited predominantly cutaneous reactions (redness, itchy swelling).
• One patient experienced an increase in ventilating pressure during anesthesia; no severe systemic reactions were reported, with histamine levels ≤1 ng/ml.

Impact:

• The improved Polygeline preparation demonstrates an acceptable safety profile with a low risk of severe adverse events.
• Findings suggest that Polygeline is well-tolerated, with primarily mild, cutaneous reactions.
• This study provides valuable data for clinicians regarding the safe use of Polygeline in anesthesia and volume replacement therapy.