Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| protamine | Drug | Protamine infusion exposures |
|
| 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 |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
elective cardiac By-Pass surgery cases
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Menekse Oksar, M.D. | Mustafa Kemal University Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mustafa Kemal University Hospital | Antakya | Hatay | 31100 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25070464 | Result | 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. | |
| 18005384 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007022 | Hypotension |
| D000707 | Anaphylaxis |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
Not provided
Not provided
| ID | Term |
|---|---|
| D011479 | Protamines |
| C037441 | glucosulfone |
| ID | Term |
|---|---|
| D009687 | Nuclear Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009698 | Nucleoproteins |
Not provided
Not provided
Not provided
Not provided
Not provided
| 30 min |
| 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. |
| 12960536 | 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. |
| 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. | View source |
| 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. | View source |
| D007154 |
| Immune System Diseases |