Clinical trial NCT03408158: 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
Overall status: COMPLETED
Phase: NA
Conditions: Blood Disease
Platelet Refractoriness
Antibody-mediated Rejection
Keywords: HPA
Blood disease
Lead sponsor: Guangzhou First People's Hospital
Sponsor class: OTHER
Collaborators: name: LanZhou University
name: First Affiliated Hospital of Harbin Medical University
name: Hunan Provincial People's Hospital
name: The Fourth Affiliated Hospital of China Medical University
name: The Third Affiliated Hospital of Guangzhou Medical University
name: First Affiliated Hospital Xi'an Jiaotong University
name: Nanfang Hospital, Southern Medical University
name: Sun Yat-sen University
First posted: 2018-01-23
Enrollment: 6170
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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: 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.

Eligibility criteria: 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.

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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. -

Primary outcomes:
measure: The percentages (%) of hematopoietic patients with anti-HPA antibodies among all investigated hematopoietic patients who need long-term infusion of platelets.
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou First People's Hospital
state: Guangdong
Study officials:
affiliation: Director of Blood Transfusion Department
name: Yaming Wei, Doctor
role: STUDY_CHAIR
References:
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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.
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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.
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.
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.