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NCT02644785
Investigation of Anaphylactic Reaction in Cases Undergoing Cardiac By-Pass Surgery
trial testing protamine in Protamine Allergy in 30 participants. Completed in 1 February 2016.
1 February 2016
Quick facts
| Lead sponsor | Mustafa Kemal University |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 30 |
| Start date | 1 January 2016 |
| Primary completion | 1 February 2016 |
| Estimated completion | 1 February 2016 |
| Sites | 1 location across Turkey (Türkiye) |
Drugs / interventions tested
- protamine — full drug profile →
Conditions studied
- Protamine Allergy — all drugs for Protamine Allergy →
- Protamine Adverse Reaction — all drugs for Protamine Adverse Reaction →
Sponsor
Mustafa Kemal University
Who can join
19 and older, any sex, with Protamine Allergy or Protamine Adverse Reaction. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Patients number with high tryptase level (> 25 µg/L ).
Time frame: 30 min
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.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02644785
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02644785 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Mustafa Kemal University
- Last refreshed: 21 March 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02644785.
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