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Effect of Anti-histamine in Prevention Systolic Hypotension After Protamine

Primary Purpose

Protamine Adverse Reaction

Status

Completed

Phase

Phase 4

Locations

Thailand

Study Type

Interventional

Intervention

Chlorpheniramine and ranitidine

0.9% Normal Saline

About this trial

This is an interventional prevention trial for Protamine Adverse Reaction focused on measuring protamine, antihistamine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

ASA physical status 1-3
Schedule for open heart surgery

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

Sites / Locations

Siriraj Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

0.9% Normal Saline

Chlorpheniramine and ranitidine

Arm Description

Syringe No 1 contain normal saline 1 mL Syringe No 2 contain normal saline 2 mL

Syringe No 1 contain chlorpheniramine 10 mg (1 mL) Syringe No 2 contain ranitidine 50 mg (2 mL)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Serum tryptase

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

Full Information

NCT ID

NCT03583567

First Posted

June 7, 2018

Last Updated

August 31, 2021

Sponsor

Mahidol University

1. Study Identification

Unique Protocol Identification Number

NCT03583567

Brief Title

Effect of Anti-histamine in Prevention Systolic Hypotension After Protamine

Official Title

A Randomized Controlled Study Comparing the Prophylactic Effect of histamine1 and Histamine 2 Receptor Blocker in Prevention Systolic Hypotension After Protamine Administration in Cardiac Patient Having Cardiopulmonary Bypass

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Completed

Study Start Date

September 5, 2018 (Actual)

Primary Completion Date

March 31, 2019 (Actual)

Study Completion Date

March 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mahidol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Protamine Adverse Reaction

Keywords

protamine, antihistamine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

normal saline will be used as placebo in control group

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

0.9% Normal Saline

Arm Type

Placebo Comparator

Arm Description

Syringe No 1 contain normal saline 1 mL Syringe No 2 contain normal saline 2 mL

Arm Title

Chlorpheniramine and ranitidine

Arm Type

Experimental

Arm Description

Syringe No 1 contain chlorpheniramine 10 mg (1 mL) Syringe No 2 contain ranitidine 50 mg (2 mL)

Intervention Type

Drug

Intervention Name(s)

Chlorpheniramine and ranitidine

Intervention Description

Patient will receive intravenous chlorpheniramine and ranitidine prior to protamine.

Intervention Type

Drug

Intervention Name(s)

0.9% Normal Saline

Intervention Description

Patient will receive normal saline as placebo.

Primary Outcome Measure Information:

Title

Blood pressure

Description

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

Secondary Outcome Measure Information:

Title

Serum tryptase

Description

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

Time Frame

60 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: ASA physical status 1-3 Schedule for open heart surgery 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sirilak Suksompong, MD

Organizational Affiliation

Mahidol University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Siriraj Hospital

City

Bangkok

ZIP/Postal Code

10700

Country

Thailand

12. IPD Sharing Statement

Plan to Share IPD

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Effect of Anti-histamine in Prevention Systolic Hypotension After Protamine

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