Antihistamine for Prevention of HTR After Blood Primed CPB | NCT07536152

Studies
Antihistamine for Prevention of HTR After Blood Primed CPB

NCT07536152

Sponsor

Kasr El Aini Hospital

Status

Recruiting

Last Update Posted

Apr 21, 2026Actual

Enrollment

40Estimated

Phase

Phase 4

Conditions

Blood Transfusion Associated Adverse Reactions

Interventions

Antihestamine
Placebo

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2026Actual

Primary Completion Date

Nov 2026Estimated

Completion Date

Dec 2026Estimated

First Submitted Date

Apr 11, 2026

First Submission Date that Met QC Criteria

Apr 11, 2026

First Posted Date

Apr 17, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 16, 2026

Last Update Posted Date

Apr 21, 2026Actual

Name	Class
Misr University for Science and Technology	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study will be a randomized, double-blinded, placebo-controlled study conducted at a university hospital. Forty children undergoing elective repair of a congenital heart defect will be included. The patients will be randomly allocated (20 patients per group) to receive a single intravenous dose of combined chlorpheniramine or normal saline immediately after separation from CPB, before protamine administration.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Antihistamine	Active Comparator	chlorpheniramine 0.25 mg/Kg in 2 ml	Drug: Antihestamine
control	Placebo Comparator	equal volume of normal saline	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Antihestamine	Drug	chlorpheniramine 0.25 mg/Kg in 2 ml immediately after separation from CPB, before protamine administration	Antihistamine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
hypotention episode incidance	Incidence of hypotension (20% MBP drop < baseline)15 minutes post-CBP weaning	15 min,post cardiopulmonary bypass weaning

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Acyanotic congenital heart disease.
Age :1 -7 years.
Genre: both.

Exclusion Criteria:

Redo patient.
History of allergy to antihistamines.
Bleeding disorders with INR > 1.5 and/or platelets < 50,000.
Emergency procedure.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

7 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Misr Universty for Scince and Technology	Recruiting	Giza	October	12582	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D065227	Transfusion Reaction

Ancestor Terms

ID	Term
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D007154	Immune System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002744	Chlorpheniramine

Ancestor Terms

ID	Term
D010632	Pheniramine
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided