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Efficacy of Placebo Versus Chlorpheniramine for the Prevention of Allergic Transfusion Reactions.

Primary Purpose

Allergic Transfusion Reaction

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Placebo
Chlorpheniramine
Sponsored by
Institute of Hematology & Blood Diseases Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Allergic Transfusion Reaction focused on measuring pretransfusion medication, Chlorpheniramine, blood transfusion, allergic transfusion reaction

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18~65 years old.
  • Subject is diagnosed with hematological disorder and requires blood product (i.e. suspended red blood cells, apheresis platelets, fresh frozen plasma) transfusions.
  • Subject can fully understand and voluntarily sign informed consent forms.

Exclusion Criteria:

  • Subject with a history of allergic diseases.
  • Subject experienced at least 1 moderate/severe or 2 mild allergic reactions in the past.
  • Subject received glucocorticoid or allergy drugs within 24 hours before blood transfusion.
  • Subject transfused with washed RBC.
  • Received allo-HSCT transplantation before.
  • Subject with heart failure.
  • Subject suffered from sequelae of cardiovascular or cerebrovascular diseases.
  • Pregnant or nursing women.
  • Inability to understand or to follow study procedures.

Sites / Locations

  • Zhoukou Central Hospital
  • The Second Affilated Hospital of Shandong First Medical University
  • Regenerative Medicine CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Placebo

Chlorpheniramine

Arm Description

Each recruited subject will oral 8mg placebo 20 minutes before blood transfusion.

Each recruited subject will oral 8mg chlorpheniramine 20 minutes before blood transfusion.

Outcomes

Primary Outcome Measures

The rate of allergic-transfusion reactions

Secondary Outcome Measures

Full Information

First Posted
December 25, 2020
Last Updated
December 4, 2022
Sponsor
Institute of Hematology & Blood Diseases Hospital, China
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1. Study Identification

Unique Protocol Identification Number
NCT04688736
Brief Title
Efficacy of Placebo Versus Chlorpheniramine for the Prevention of Allergic Transfusion Reactions.
Official Title
A Prospective, Randomized, Double-blind Controlled Trial of Chlorpheniramine Pretransfusion Medication for Allergic Transfusion Reactions
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
June 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institute of Hematology & Blood Diseases Hospital, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a prospective, randomized, double-blind controlled trial to evaluate the efficacy of placebo versus chlorpheniramine for the prevention of allergic transfusion reactions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Transfusion Reaction
Keywords
pretransfusion medication, Chlorpheniramine, blood transfusion, allergic transfusion reaction

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Neither patients nor medical staff, including physicians and nurses participating in this study, will know the group assignment after allocation.
Allocation
Randomized
Enrollment
6642 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Experimental
Arm Description
Each recruited subject will oral 8mg placebo 20 minutes before blood transfusion.
Arm Title
Chlorpheniramine
Arm Type
Active Comparator
Arm Description
Each recruited subject will oral 8mg chlorpheniramine 20 minutes before blood transfusion.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
The tablet resembles chlorpheniramine but has no therapeutic value.
Intervention Type
Drug
Intervention Name(s)
Chlorpheniramine
Intervention Description
An antihistamine that reduces the natural chemical histamine in the body.
Primary Outcome Measure Information:
Title
The rate of allergic-transfusion reactions
Time Frame
within 4 hours from the start of the transfusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18~65 years old. Subject is diagnosed with hematological disorder and requires blood product (i.e. suspended red blood cells, apheresis platelets, fresh frozen plasma) transfusions. Subject can fully understand and voluntarily sign informed consent forms. Exclusion Criteria: Subject with a history of allergic diseases. Subject experienced at least 1 moderate/severe or 2 mild allergic reactions in the past. Subject received glucocorticoid or allergy drugs within 24 hours before blood transfusion. Subject transfused with washed RBC. Received allo-HSCT transplantation before. Subject with heart failure. Subject suffered from sequelae of cardiovascular or cerebrovascular diseases. Pregnant or nursing women. Inability to understand or to follow study procedures.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Shi, PhD
Phone
(86)2223900913
Email
shijun@ihcams.ac.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Jingyu Zhao, MPH
Phone
(86)13752253515
Email
zhaojingyu@ihcams.ac.cn
Facility Information:
Facility Name
Zhoukou Central Hospital
City
Zhoukou
State/Province
Henan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qian Liang, PhD
Phone
15703815972
Email
lqw141230@163.com
Facility Name
The Second Affilated Hospital of Shandong First Medical University
City
Tai'an
State/Province
Shandong
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Zhang
Phone
18505386878
Email
tyfyzhh@163.com
Facility Name
Regenerative Medicine Center
City
Tianjin
State/Province
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Shi, PhD
Phone
(86)2223900913
Email
shijun@ihcams.ac.cn
First Name & Middle Initial & Last Name & Degree
Zhexiang Kuang, MN
Email
kuangzhexiang@ihcams.ac.cn

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficacy of Placebo Versus Chlorpheniramine for the Prevention of Allergic Transfusion Reactions.

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