HPA Antibodies and the Distribution of Antigen and Antibodies

August 5, 2021 updated by: Guangzhou First People's Hospital

Multi-center Study in the Frequency of HPA Antibodies and the Distribution of Antigen and Antibodies in Chinese Blood Disease Patients

By detecting platelet antibodies of participants and then further to identify their genotype and analyzing laboratory examination, the investigators will obtain positive frequency of HPA antibodies, the distribution of HPA antigen and antibodies, effect of matching platelet transfusion, all of which in favor of draw a conclusion that it is very important to carry out HPA antibody detection and matching transfusion in early phase.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  1. The investigators will detect platelet antibodies of participants who are according with the inclusive criteria.
  2. For participants with platelet antibodies, the investigators should screen out cases owning HPA antibodies and further to identify their genotype.
  3. Platelet infusion of same type will be applied to half of participants with HPA antibodies as experimental group, and the another half of participants with hematopathy will be infused ordinary platelets as control. The investigators will estimate the effect of matching transfusion through laboratory examination such as platelet count 1 hour and 24 hours after transfusion and clinical feature comparing to control group.
  4. Finally, the investigators will obtain several conclusions includes positive frequency of HPA antibodies, the distribution of HPA antigen and antibodies, effect of matching platelet transfusion by analyzing a bunch of relevant information. So, strong evidence will be provide to decide if it is very important to carry out HPA antibody detection and matching transfusion in early phase.

Study Type

Interventional

Enrollment (Actual)

6170

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 210000
        • Guangzhou First People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Blood disease patients with voluntary participation in creating records, no gender limitation, 0-99 years of age, first diagnosed or be hospitalized in our hospital with platelet transfusion more than once.
  2. Patients transfers from other hospitals which can be confirm the time (>1) of platelet transfusion.
  3. Patient be cured, discharged or dead with the time of platelet transfusion is between 1 to 10 should be included.

  4. Patient with HPA antibodies at admission could be considered to be included into same type transfusion group.

    -

Exclusion Criteria:

  1. Patients informed but refuse to participate in;
  2. Patients with HPA antibodies quitting therapy or breaking off cooperation during research;
  3. Patients with many referrals and the time of platelet transfusion can not be confirmed;
  4. Patient without platelet transfusion;
  5. Patient with termination of treatment whatever active or passive. -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: HPA antigen and antibodies
Investigate the positive rate of HPA antibodies, the distribution and the specificity of HPA antigen and antibodies in Chinese blood disease patients.
NO_INTERVENTION: necessity of HPA antibodies screening
Investigate the connection between times of platelet transplantation and HPA antibody titer, which providing statistical data for evaluating the necessity and setting screening time and standards of HPA antibodies screening.
EXPERIMENTAL: matched platlet infusion
Enable platelet donors'common HPA antigen to be typed and blood disease patients to be same type infusion of main HPA antigen as possible as early.The investigators compare the differences of platelet count between patients with same type infusion of main HPA antigen and not.
Procedure: same type infusion of main HPA antigen
Compare the differences of platelet count between participants with same type infusion of main HPA antigen and not

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The percentages (%) of hematopoietic patients with anti-HPA antibodies among all investigated hematopoietic patients who need long-term infusion of platelets.
Time Frame: From one participant first enrolled in this study to the moment of HPA antibodies could be detected or death, up to 6 months. The investigators will calculate the percentages after all participants are done with trace.
The investigators will recruit about 25000 participants in total (anticipated) of different hospitals spread over the whole country and divide them into two categories, patients with and patients without platelet antibodies, by detecting antibodies through solid-phase agglutination (qualitative analysis). The investigators screen out the positive ones and then distinguish participants with antibodies against human platelet antigens (HPA) from those with antibodies against human leukocyte antigens (HLA) by using LIFECODES PAKPLUS (qualitative analysis). At the same time, subtype of anti-HPA antibodies (such as anti-HPA-1a antibodies) are detected. The analyzation of large sample data will present investigators the most important findings, the percentages (%, the primary outcome measure) of hematopoietic patients with anti-HPA antibodies (include the total and the various subtypes) among all investigated hematopoietic patients who need long-term infusion of platelets.
From one participant first enrolled in this study to the moment of HPA antibodies could be detected or death, up to 6 months. The investigators will calculate the percentages after all participants are done with trace.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangzhou First People's Hospital

Collaborators

LanZhou University
Sun Yat-sen University
The Third Affiliated Hospital of Guangzhou Medical University
First Affiliated Hospital Xi'an Jiaotong University
Nanfang Hospital of Southern Medical University
Hunan Provincial People's Hospital
First Affiliated Hospital of Harbin Medical University
The Fourth Affiliated Hospital of China Medical University

Investigators

  • Study Chair: Yaming Wei, Doctor, Director of Blood Transfusion Department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2017

Primary Completion (ACTUAL)

December 31, 2020

Study Completion (ACTUAL)

December 31, 2020

Study Registration Dates

First Submitted

December 4, 2017

First Submitted That Met QC Criteria

January 17, 2018

First Posted (ACTUAL)

January 23, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 12, 2021

Last Update Submitted That Met QC Criteria

August 5, 2021

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K2016-116-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We plan to share IPD with other researchers 5 years after the termination of the whole study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Blood Disease

Clinical Trials on same type infusion of main HPA antigen

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Spain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe