HPA Antibodies and the Distribution of Antigen and Antibodies

Guangzhou First People's Hospital

Status: Completed

Conditions: Antibody-mediated Rejection; Blood Disease; Platelet Refractoriness

Treatments: Procedure: same type infusion of main HPA antigen

Study type: Interventional

Funder types: Other

Identifiers

NCT03408158

K2016-116-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6,170 patients

Sex: All

Volunteers: No 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. -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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6,170 participants in 3 patient groups

HPA antigen and antibodies

No Intervention group

Description:

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 group

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.

matched platlet infusion

Experimental group

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.

Treatment:

Procedure: same type infusion of main HPA antigen