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Completed

NCT Number: NCT02644785

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

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.

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Key information

Conditions

Protamine Allergy Anaphylaxis Cardiovascular Diseases Hypersensitivity Hypersensitivity, Immediate Hypotension Immune System Diseases Protamine Adverse Reaction Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mustafa Kemal University Hospital

Antakya, Hatay, 31100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Cardiac by-pass cases

Exclusion criteria

  • Insulin dependent diabetes
  • Atopy
  • Drug allergy history

Treatment and study plan

Protamine

Drug

Protamine infusion exposures

Other names: promin

Primary outcomes

  1. Patients number with high tryptase level (> 25 µg/L ).

    Time frame: 30 min

    Tryptase will be measured using the ImmunoCAP Tryptase kit (Phadia, Uppsala, Sweden), and the cutoff level for elevated tryptase is >11.5 µg/L. A 25 µg/L cutoff value has been found to be highly suggestive of an İmmunoglobulin E (IgE) -mediated reaction.

Secondary outcomes

  1. Patients number with allergic reaction involving of 1 or more organ/systems (skin, respiratory, or cardiovascular system) following the study drug infusion. In this study, mainly the cardiovascular and skin symptoms will be focused on.

    Time frame: 30 min

    These outcomes will be determined following the Council for International Organizations of Medical Sciences (CIOMS 1999 and ) definitions for anaphylactic reactions. Additionally, (World Health Organization - Uppsala Monitoring Centre) WHO-UMC system will be used for assesment of causality categories for adverse drug reactions.

Sponsors and collaborators

Lead sponsor

Mustafa Kemal University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 1, 2016
Registry last updated
Mar 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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