HPA Antibodies and the Distribution of Antigen and Antibodies
NCT ID: NCT03408158
Last Updated: 2021-08-12
Study Results
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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COMPLETED
NA
6170 participants
INTERVENTIONAL
2017-01-01
2020-12-31
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
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.
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.
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.
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
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
Eligibility Criteria
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Inclusion Criteria
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
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. -
ALL
No
Sponsors
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LanZhou University
OTHER
First Affiliated Hospital of Harbin Medical University
OTHER
Hunan Provincial People's Hospital
OTHER
The Fourth Affiliated Hospital of China Medical University
OTHER
The Third Affiliated Hospital of Guangzhou Medical University
OTHER
First Affiliated Hospital Xi'an Jiaotong University
OTHER
Nanfang Hospital, Southern Medical University
OTHER
Sun Yat-sen University
OTHER
Guangzhou First People's Hospital
OTHER
Responsible Party
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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
Countries
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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K2016-116-01
Identifier Type: -
Identifier Source: org_study_id
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