A Phase 4 interventional study of Chlorpheniramine and ranitidine and 0.9% Normal Saline in Protamine Adverse Reaction, sponsored by Mahidol University. Completed at 1 site in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-01.
Sponsored by Mahidol University · Phase 4, Interventional, and Prevention
Protamine remains the anticoagulant of choice for cardiopulmonary bypass (CPB). The process of protamine neutralization of heparin came with the side effects sometimes; it can be life threatening or fetal reaction. The adverse cardiopulmonary response of protamine has been observed during entire history of clinical cardiac surgery. The true mechanism reaction is difficult to defined and the complexity of the clinical situation The classification of protamine reaction has been divided in to main 3 types (transient systemic hypotension secondary to rapid administration, anaphylactic and anaphylactoid reaction and catastrophic pulmonary vasoconstriction.
The reaction from pharmacologic histamine release is the most common type of reaction. Protamine was believed to induce hypotension by this mechanism, and it was demonstrated to release histamine by degranulation of isolated mast cells From the hypothesis that the systemic hypotension cause by the released of histamine. The investigators will measure the serum tryptase which is the enzyme that released from degranulation of human mast cell. Comparing the serum tryptase level of the patient at baseline, 30 min and 60 min after protamine was given.
There for the hypothesis of this study is administrating of H1 and H2 blocker helps attenuate the drop in MAP after protamine is given.
1,003 studies on the registry are indexed under Hypotension; 173 are open to participants now.
This study's enrollment of 40 is below the median of 80 across 675 interventional studies indexed under Hypotension.
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Exclusion Criteria:
Syringe No 1 contain normal saline 1 mL Syringe No 2 contain normal saline 2 mL
Drug: 0.9% Normal Saline
Syringe No 1 contain chlorpheniramine 10 mg (1 mL) Syringe No 2 contain ranitidine 50 mg (2 mL)
Drug: Chlorpheniramine and ranitidine
Patient will receive intravenous chlorpheniramine and ranitidine prior to protamine.
Patient will receive normal saline as placebo.
Blood pressure
Systolic and diastolic blood pressure will be recorded every minutes since the start of protamine infusion (in 7 minutes) til 30 minutes after infusion.
Time frame: 37 minutes
Serum tryptase
Serum tryptase will be measured before the administration of protamine and at 30 minutes and 60 minutes after protamine
Time frame: 60 minutes
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Mahidol University