Serum Tryptase Levels During Cardiac Surgery, Diagnosis and Treatment Decisions for Allergic Reactions
NCT ID: NCT02644785
Last Updated: 2017-03-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
30 participants
OBSERVATIONAL
2016-01-31
2016-02-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Prophylactic Methylprednisolone for Renal Protection in Cardiac Surgeries With Cardiopulmonary Bypass
NCT06917859
Single Dose Administration of Alpha-1 Anti-Trypsin for the Amelioration of Organ Injury in Patients Undergoing Cardiac Surgery
NCT02191839
REGIONAL ANALGESIA TECHNIQUES FOR EFFECTIVE RECOVERY TO CORONARY ARTERY BYPASS SURGERIES: A RETROSPECTİVE STUDY IN A SINGLE CENTER EXPERIENCE
NCT05282303
Combination of Parasternal and Serratus Anterior Plane Block in Coronary Artery Bypass Graft Surgery
NCT06326333
Effect of Cardiovascular Autonomic Neuropathy on AKI and Outcomes in Isolated CABG Surgery
NCT07254468
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
protamine
Protamine infusion exposures
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Atopy
* Drug allergy history
19 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Mustafa Kemal University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
MENEKSE OKSAR
Assistant Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Menekse Oksar, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mustafa Kemal University Medical School
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mustafa Kemal University Hospital
Antakya, Hatay, Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Related Links
Access external resources that provide additional context or updates about the study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2014/10
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.