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HPA Antibodies and the Distribution of Antigen and Antibodies

Primary Purpose

Blood Disease, Platelet Refractoriness, Antibody-mediated Rejection

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
same type infusion of main HPA antigen
Sponsored by
Guangzhou First People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Blood Disease focused on measuring HPA, Blood disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. -

Sites / Locations

  • Guangzhou First People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

No Intervention

Experimental

Arm Label

HPA antigen and antibodies

necessity of HPA antibodies screening

matched platlet infusion

Arm Description

Investigate the positive rate of HPA antibodies, the distribution and the specificity of HPA antigen and antibodies in Chinese blood disease patients.

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.

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.

Outcomes

Primary Outcome Measures

The percentages (%) of hematopoietic patients with anti-HPA antibodies among all investigated hematopoietic patients who need long-term infusion of platelets.
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.

Secondary Outcome Measures

Full Information

First Posted
December 4, 2017
Last Updated
August 5, 2021
Sponsor
Guangzhou First People's Hospital
Collaborators
LanZhou University, First Affiliated Hospital of Harbin Medical University, Hunan Provincial People's Hospital, The Fourth Affiliated Hospital of China Medical University, The Third Affiliated Hospital of Guangzhou Medical University, First Affiliated Hospital Xi'an Jiaotong University, Nanfang Hospital, Southern Medical University, Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT03408158
Brief Title
HPA Antibodies and the Distribution of Antigen and Antibodies
Official Title
Multi-center Study in the Frequency of HPA Antibodies and the Distribution of Antigen and Antibodies in Chinese Blood Disease Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guangzhou First People's Hospital
Collaborators
LanZhou University, First Affiliated Hospital of Harbin Medical University, Hunan Provincial People's Hospital, The Fourth Affiliated Hospital of China Medical University, The Third Affiliated Hospital of Guangzhou Medical University, First Affiliated Hospital Xi'an Jiaotong University, Nanfang Hospital, Southern Medical University, Sun Yat-sen University

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
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.
Detailed Description
The investigators will detect platelet antibodies of participants who are according with the inclusive criteria. For participants with platelet antibodies, the investigators should screen out cases owning HPA antibodies and further to identify their genotype. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Disease, Platelet Refractoriness, Antibody-mediated Rejection
Keywords
HPA, Blood disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
6170 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HPA antigen and antibodies
Arm Type
No Intervention
Arm Description
Investigate the positive rate of HPA antibodies, the distribution and the specificity of HPA antigen and antibodies in Chinese blood disease patients.
Arm Title
necessity of HPA antibodies screening
Arm Type
No Intervention
Arm Description
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.
Arm Title
matched platlet infusion
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
same type infusion of main HPA antigen
Intervention Description
Compare the differences of platelet count between participants with same type infusion of main HPA antigen and not
Primary Outcome Measure Information:
Title
The percentages (%) of hematopoietic patients with anti-HPA antibodies among all investigated hematopoietic patients who need long-term infusion of platelets.
Description
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.
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.

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Patients transfers from other hospitals which can be confirm the time (>1) of platelet transfusion. Patient be cured, discharged or dead with the time of platelet transfusion is between 1 to 10 should be included. Patient with HPA antibodies at admission could be considered to be included into same type transfusion group. - Exclusion Criteria: Patients informed but refuse to participate in; Patients with HPA antibodies quitting therapy or breaking off cooperation during research; Patients with many referrals and the time of platelet transfusion can not be confirmed; Patient without platelet transfusion; Patient with termination of treatment whatever active or passive. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yaming Wei, Doctor
Organizational Affiliation
Director of Blood Transfusion Department
Official's Role
Study Chair
Facility Information:
Facility Name
Guangzhou First People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
210000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We plan to share IPD with other researchers 5 years after the termination of the whole study.
Citations:
PubMed Identifier
18070275
Citation
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Results Reference
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PubMed Identifier
18564396
Citation
Kerkhoffs JL, Eikenboom JC, van de Watering LM, van Wordragen-Vlaswinkel RJ, Wijermans PW, Brand A. The clinical impact of platelet refractoriness: correlation with bleeding and survival. Transfusion. 2008 Sep;48(9):1959-65. doi: 10.1111/j.1537-2995.2008.01799.x. Epub 2008 Jun 28.
Results Reference
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PubMed Identifier
10911376
Citation
Meehan KR, Matias CO, Rathore SS, Sandler SG, Kallich J, LaBrecque J, Erder H, Schulman KA. Platelet transfusions: utilization and associated costs in a tertiary care hospital. Am J Hematol. 2000 Aug;64(4):251-6. doi: 10.1002/1096-8652(200008)64:43.0.co;2-n.
Results Reference
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PubMed Identifier
25467707
Citation
Mishima Y, Tsuno NH, Matsuhashi M, Yoshizato T, Sato T, Ikeda T, Watanabe-Okochi N, Nagura Y, Sone S, Kurokawa M, Okazaki H. Effects of universal vs bedside leukoreductions on the alloimmunization to platelets and the platelet transfusion refractoriness. Transfus Apher Sci. 2015 Feb;52(1):112-21. doi: 10.1016/j.transci.2014.11.001. Epub 2014 Nov 11.
Results Reference
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PubMed Identifier
20921943
Citation
Ramirez P, Brunstein CG, Miller B, Defor T, Weisdorf D. Delayed platelet recovery after allogeneic transplantation: a predictor of increased treatment-related mortality and poorer survival. Bone Marrow Transplant. 2011 Jul;46(7):981-6. doi: 10.1038/bmt.2010.218. Epub 2010 Oct 4.
Results Reference
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PubMed Identifier
16262760
Citation
Macher S, Schallmoser K, Staber PB, Neumeister P, Posch U, Lanzer G, Panzer S. Severe thrombocytopenia due to host-derived anti-HPA-1a after non-myeloablative allogeneic haematopoietic stem cell transplantation for multiple myeloma: a case report. Vox Sang. 2005 Nov;89(4):257-60. doi: 10.1111/j.1423-0410.2005.00692.x.
Results Reference
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PubMed Identifier
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Citation
Lucas G, Culliford S, Green F, Sidra G, Calvert A, Green A, Harrison P, Harvey J, Allen D, Smillie D, Masurekar A, Marks D, Russell N, Massey E. Recipient-derived HPA-1a antibodies: a cause of prolonged thrombocytopenia after unrelated donor stem cell transplantation. Transfusion. 2010 Feb;50(2):334-9. doi: 10.1111/j.1537-2995.2009.02448.x. Epub 2009 Oct 23.
Results Reference
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HPA Antibodies and the Distribution of Antigen and Antibodies

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