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

NCT02644785 | Completed DMC

• 1 other identifier: 2014/10
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Protamine Allergy; Protamine Adverse Reaction

Keywords

cardiac by-pass; protamine; tryptase; hypotension; anaphylaxis

Outcome Measures

Primary Outcomes (1)

• 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 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.

  30 min

Interventions

protamine DRUG

Protamine infusion exposures

Also known as: promin

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

elective cardiac By-Pass surgery cases

You may qualify if:

• Cardiac by-pass cases

You may not qualify if:

• Insulin dependent diabetes
• Atopy
• Drug allergy history

Sponsors & Collaborators

• Mustafa Kemal University: lead

Study Sites (1)

Mustafa Kemal University Hospital

Antakya, Hatay, 31100, Turkey (Türkiye)

Location

Related 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 diagnostic performance of acute serum tryptase. Clin Exp Immunol. 2014 Nov;178(2):399-404. doi: 10.1111/cei.12424.

  PMID: 25070464 RESULT

• 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.

  PMID: 18005384 RESULT

• 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.

  PMID: 12960536 RESULT

Related 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.

MeSH Terms

Conditions

Hypotension; Anaphylaxis

Interventions

Protamines; glucosulfone

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Nuclear Proteins; Proteins; Amino Acids, Peptides, and Proteins; Nucleoproteins

Study Officials

• Menekse Oksar, M.D.

  Mustafa Kemal University Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 24, 2015
• First Posted: January 1, 2016
• Study Start: January 1, 2016
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: March 22, 2017

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)