NCT03583567

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2018

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 7, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 11, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

September 5, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
Last Updated

September 1, 2021

Status Verified

August 1, 2021

Enrollment Period

7 months

First QC Date

June 7, 2018

Last Update Submit

August 31, 2021

Conditions

Protamine Adverse Reaction

Keywords

protamineantihistamine

Outcome Measures

Primary Outcomes (1)

  • 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.

    37 minutes

Secondary Outcomes (1)

  • Serum tryptase

    60 minutes

Study Arms (2)

0.9% Normal Saline

PLACEBO COMPARATOR

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

Drug: 0.9% Normal Saline

Chlorpheniramine and ranitidine

EXPERIMENTAL

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

Drug: Chlorpheniramine and ranitidine

Interventions

Chlorpheniramine and ranitidineDRUG

Patient will receive intravenous chlorpheniramine and ranitidine prior to protamine.

Chlorpheniramine and ranitidine
0.9% Normal SalineDRUG

Patient will receive normal saline as placebo.

0.9% Normal Saline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Siriraj Hospital

Bangkok, 10700, Thailand

Location

Related Publications (1)

  • Suksompong S, Wongsripuemtet P, Srinoulprasert Y, Khamtuikrua C, Chaikittisilpa N. H1 and H2 antihistamines pretreatment for attenuation of protamine reactions after cardiopulmonary bypass: a randomized-controlled study. Ann Palliat Med. 2023 Jan;12(1):47-59. doi: 10.21037/apm-22-714. Epub 2022 Dec 16.

    PMID: 36571171DERIVED

MeSH Terms

Interventions

ChlorpheniramineRanitidineSaline Solution

Intervention Hierarchy (Ancestors)

PheniraminePyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFuransCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Sirilak Suksompong, MD

    Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
normal saline will be used as placebo in control group
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2018

First Posted

July 11, 2018

Study Start

September 5, 2018

Primary Completion

March 31, 2019

Study Completion

March 31, 2019

Last Updated

September 1, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)