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

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

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.

Study Overview

• Status: Completed
• Conditions: Protamine Adverse Reaction; Protamine Allergy
• Intervention / Treatment: Drug: protamine

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.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Turkey
  • Hatay, Turkey, 31100
    • Mustafa Kemal University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

elective cardiac By-Pass surgery cases

Description

Inclusion Criteria:

• Cardiac by-pass cases

Exclusion Criteria:

• Insulin dependent diabetes
• Atopy
• Drug allergy history

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients number with high tryptase level (> 25 µg/L ).	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.	30 min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	30 min

Collaborators and Investigators

• Sponsor: Mustafa Kemal University
• Investigators: Principal Investigator: Menekse Oksar, M.D., Mustafa Kemal University Medical School

Publications and helpful links

General Publications

• Krishna MT, York M, Chin T, Gnanakumaran G, Heslegrave J, Derbridge C, Huissoon A, Diwakar L, Eren E, Crossman RJ, Khan N, Williams AP. Multi-centre retrospective analysis of anaphylaxis during general anaesthesia in the United Kingdom: aetiology and diagnostic performance of acute serum tryptase. Clin Exp Immunol. 2014 Nov;178(2):399-404. doi: 10.1111/cei.12424.
• Malinovsky JM, Decagny S, Wessel F, Guilloux L, Mertes PM. Systematic follow-up increases incidence of anaphylaxis during adverse reactions in anesthetized patients. Acta Anaesthesiol Scand. 2008 Feb;52(2):175-81. doi: 10.1111/j.1399-6576.2007.01489.x. Epub 2007 Nov 13.
• Mertes PM, Laxenaire MC, Alla F; Groupe d'Etudes des Reactions Anaphylactoides Peranesthesiques. Anaphylactic and anaphylactoid reactions occurring during anesthesia in France in 1999-2000. Anesthesiology. 2003 Sep;99(3):536-45. doi: 10.1097/00000542-200309000-00007.

Helpful Links

• The authors reported that elevated acute serum tryptase (>141% from baseline or absolute tryptase >15.7 mg/L) is highly predictive of IgE-mediated anaphylaxis and that these two methods of interpretation are comparable.
• Malinovsky et al. reported that tryptase concentrations were elevated in 50% of their patients, and the positive and negative predictive values (PPV and NPV) of tryptase were 100% for both tryptase >12 and >25 at the first samples.
• Krishna et al. reported sensitivities, specificities, PPV and NPV for a tryptase of >25 mcg/L to be 64, 74, 82 and 52 respectively in 103 patients which were similar to the values reported by Mertes et al.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: December 24, 2015
• First Submitted That Met QC Criteria: December 30, 2015
• First Posted (Estimate): January 1, 2016

Study Record Updates

• Last Update Posted (Actual): March 22, 2017
• Last Update Submitted That Met QC Criteria: March 21, 2017
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: tryptase; hypotension; anaphylaxis; protamine; cardiac by-pass
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Coagulants; Heparin Antagonists; Protamines
• Other Study ID Numbers: 2014/10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO