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Completed

NCT Number: NCT03583567

Effect of Anti-histamine in Prevention Systolic Hypotension After Protamine

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Siriraj Hospital

Bangkok, 10700, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chlorpheniramine and ranitidine

Drug

Patient will receive intravenous chlorpheniramine and ranitidine prior to protamine.

0.9% normal saline

Drug

Patient will receive normal saline as placebo.

Primary outcomes

  1. Blood pressure

    Time frame: 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 outcomes

  1. Serum tryptase

    Time frame: 60 minutes

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

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 11, 2018
Registry last updated
Sep 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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