HPA Antibodies and the Distribution of Antigen and Antibodies

NCT03408158 | Completed

• 1 other identifier: K2016-116-01
• Study Type: interventional
• Target: 6,170
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Disease; Platelet Refractoriness; Antibody-mediated Rejection

Keywords

HPA; Blood disease

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

Study Arms (3)

HPA antigen and antibodies

NO INTERVENTION

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

necessity of HPA antibodies screening

NO INTERVENTION

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.

matched platlet infusion

EXPERIMENTAL

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

Interventions

same type infusion of main HPA antigen PROCEDURE

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

matched platlet infusion

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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. -

Sponsors & Collaborators

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

Study Sites (1)

Guangzhou First People's Hospital

Guangzhou, Guangdong, 210000, China

Location

Related Publications (7)

• 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.

  PMID: 18070275 BACKGROUND

• 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.

  PMID: 18564396 BACKGROUND

• 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.

  PMID: 10911376 BACKGROUND

• 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.

  PMID: 25467707 BACKGROUND

• 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.

  PMID: 20921943 BACKGROUND

• 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.

  PMID: 16262760 BACKGROUND

• 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.

  PMID: 19874563 BACKGROUND

MeSH Terms

Conditions

Hematologic Diseases

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases

Study Officials

• Yaming Wei, Doctor

  Director of Blood Transfusion Department

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2017
• First Posted: January 23, 2018
• Study Start: January 1, 2017
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: August 12, 2021

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)