HPA Antibodies and the Distribution of Antigen and Antibodies

NCT ID: NCT03408158

Last Updated: 2021-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2020-12-31

Brief Summary

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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

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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.

Conditions

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Blood Disease Platelet Refractoriness Antibody-mediated Rejection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

same type infusion of main HPA antigen

Intervention Type PROCEDURE

Compare the differences of platelet count between participants with same type infusion of main HPA antigen and not

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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. -
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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LanZhou University

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Harbin Medical University

OTHER

Sponsor Role collaborator

Hunan Provincial People's Hospital

OTHER

Sponsor Role collaborator

The Fourth Affiliated Hospital of China Medical University

OTHER

Sponsor Role collaborator

The Third Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role collaborator

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role collaborator

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role collaborator

Sun Yat-sen University

OTHER

Sponsor Role collaborator

Guangzhou First People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yaming Wei, Doctor

Role: STUDY_CHAIR

Director of Blood Transfusion Department

Locations

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Guangzhou First People's Hospital

Guangzhou, Guangdong, China

Site Status

Countries

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China

References

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Berry J, Allen D, Porcelijn L, de Haas M, Kekomaki R, Kaplan C, Ouwehand WH, Metcalfe P. Collaborative studies to establish the first World Health Organization International Standard for detection of human antibody against human platelet antigen-3a. Vox Sang. 2007 Nov;93(4):309-15. doi: 10.1111/j.1423-0410.2007.00899.x.

Reference Type BACKGROUND
PMID: 18070275 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18564396 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10911376 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25467707 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20921943 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16262760 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19874563 (View on PubMed)

Other Identifiers

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K2016-116-01

Identifier Type: -

Identifier Source: org_study_id

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