NCT02644785

Serum Tryptase Levels During Cardiac Surgery, Diagnosis and Treatment Decisions for Allergic Reactions

Investigation of Anaphylactic Reaction in Cases Undergoing Cardiac By-Pass Surgery

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: Mustafa Kemal University · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

The investigators aim to assess tryptase test efficacy for measuring the allergic response to protamine during cardiac bypass surgery. Additionally, the investigators aim to establish a differential diagnosis on the basis of potential allergens or clinical causes.

Detailed description

Venous blood samples from cardiac surgery cases will be obtained for tryptase measurement upon admission to the operating room (OR) and immediately prior to and 30 min after protamine infusion initiation. A rapid effect-response-based clinical assessment will be made using clinical and laboratory monitoring data for diagnosis and treatment decisions during protamine infusion, which may complicate the recovery from surgery.

Conditions

• Protamine Allergy
• Protamine Adverse Reaction

Interventions

Type	Name	Description
DRUG	protamine	Protamine infusion exposures

Timeline

• Start date: 2016-01-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2016-01-01
• Last updated: 2017-03-22

Locations

1 site across 1 country: Turkey (Türkiye)