Effect of Anti-histamine in Prevention Systolic Hypotension After Protamine

Phase 4

Completed

• Conditions: Protamine Adverse Reaction
• Interventions: Drug: 0.9% Normal Saline; Drug: Chlorpheniramine and ranitidine

• Registration Number: NCT03583567
• Lead Sponsor: Mahidol University

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-06-07
• Study First Submitted QC: 2018-06-28
• Study First Posted: 2018-07-11
• Study Start: 2018-09-05
• Primary Completion: 2019-03-31
• Study Completion: 2019-03-31
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-31
• Last Update Posted: 2021-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• ASA physical status 1-3
• Schedule for open heart surgery

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Exclusion Criteria

• History of allergy to the study drugs or protamine
• History of previous cardiac surgery or received protamine
• History of diabetes with insulin therapy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.9% Normal Saline	0.9% Normal Saline	Syringe No 1 contain normal saline 1 mL Syringe No 2 contain normal saline 2 mL
Chlorpheniramine and ranitidine	Chlorpheniramine and ranitidine	Syringe No 1 contain chlorpheniramine 10 mg (1 mL) Syringe No 2 contain ranitidine 50 mg (2 mL)

Primary Outcome Measures

Name	Time	Method
Blood pressure	37 minutes	Systolic and diastolic blood pressure will be recorded every minutes since the start of protamine infusion (in 7 minutes) til 30 minutes after infusion.

Secondary Outcome Measures

Name	Time	Method
Serum tryptase	60 minutes	Serum tryptase will be measured before the administration of protamine and at 30 minutes and 60 minutes after protamine

Trial Locations

Locations (1)

Siriraj Hospital; 🇹🇭 Bangkok, Thailand