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

Protamine Adverse Reaction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02644785
• Other study ID #: 2014/10
• Status: Completed
• Phase: N/A
• First received: December 24, 2015
• Last updated: March 21, 2017
• Start date: January 2016
• Est. completion date: February 2016

Study information

• Verified date: February 2016
• Source: Mustafa Kemal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Cardiac by-pass cases

Exclusion Criteria:

• Insulin dependent diabetes

• Atopy

• Drug allergy history

Related Conditions & MeSH terms

• Protamine Adverse Reaction
• Protamine Allergy

Intervention

Drug:
• protamine
Protamine infusion exposures

Locations

Country	Name	City	State
Turkey	Mustafa Kemal University Hospital	Hatay

Sponsors (1)

Lead Sponsor	Collaborator
Mustafa Kemal University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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 diag — View Citation

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. — View Citation

Mertes PM, Laxenaire MC, Alla F; Groupe d'Etudes des Réactions Anaphylactoïdes Peranesthésiques.. Anaphylactic and anaphylactoid reactions occurring during anesthesia in France in 1999-2000. Anesthesiology. 2003 Sep;99(3):536-45. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 Immunoglobulin E (IgE) -mediated reaction.	30 min
Secondary	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

External Links

•   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.
•   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.
•   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.