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Effect of Anti-histamine in Prevention Systolic Hypotension After Protamine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03583567
Recruitment Status : Recruiting
First Posted : July 11, 2018
Last Update Posted : September 25, 2018
Information provided by (Responsible Party):
Mahidol University

Tracking Information
First Submitted Date  ICMJE June 7, 2018
First Posted Date  ICMJE July 11, 2018
Last Update Posted Date September 25, 2018
Actual Study Start Date  ICMJE September 5, 2018
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 28, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03583567 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2018)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Effect of Anti-histamine in Prevention Systolic Hypotension After Protamine
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
normal saline will be used as placebo in control group
Primary Purpose: Prevention
Condition  ICMJE Protamine Adverse Reaction
Intervention  ICMJE
  • Drug: Chlorpheniramine and ranitidine
    Patient will receive intravenous chlorpheniramine and ranitidine prior to protamine.
  • Drug: 0.9% Normal Saline
    Patient will receive normal saline as placebo.
Study Arms  ICMJE
  • Placebo Comparator: 0.9% Normal Saline
    Syringe No 1 contain normal saline 1 mL Syringe No 2 contain normal saline 2 mL
    Intervention: Drug: 0.9% Normal Saline
  • Experimental: Chlorpheniramine and ranitidine
    Syringe No 1 contain chlorpheniramine 10 mg (1 mL) Syringe No 2 contain ranitidine 50 mg (2 mL)
    Intervention: Drug: Chlorpheniramine and ranitidine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 28, 2018)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2020
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: sirilak Suksompong, MD 66891534806
Listed Location Countries  ICMJE Thailand
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT03583567
Other Study ID Numbers  ICMJE Si 2018
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mahidol University
Study Sponsor  ICMJE Mahidol University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sirilak Suksompong, MD Mahidol University
PRS Account Mahidol University
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP