Clinical Study of Combined Platelet Transfusion
ConditionHematologic Diseases
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorThe General Hospital of Western Theater Command
About this trial
Platelet transfusion is an irreplaceable and important treatment method for clinical prevention and treatment of thrombocytopenia or platelet dysfunction. Due to various factors, it is difficult to achieve platelet ABO complete homotypic transfusion in clinical practice. When ABO-compatible platelets cannot be obtained, plasma-reduced platelets, platelets with low anti-A or anti-B titers are often used in clinical practice to reduce the risk of ABO-incompatible platelet-compatible transfusion reactions. The combined platelets prepared in this study can achieve ABO primary and secondary side compatible infusion.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
1. Aged 18-65 years; 2. Disease treatment in the research hospital; 3. Applied for platelet transfusion therapy.
Disqualifiers
1. One month before the start of this study, he participated in other clinical trials of drugs and instruments related to platelet transfusion efficacy; 2. Without platelet transfusion indications; 3. Only received platelet transfusion in the outpatient department and left the hospital without efficacy evaluation after transfusion; 4. Gave up platelet transfusion therapy for any reason after enrollment; 5. Transferred or discharged from hospital for any reason before platelet transfusion after enrollment; 6. Did not receive combined platelet transfusion during the 6-month treatment period after enrollment
Trial design
Design model
Single group
Treatments tested in this trial
Combined platelets
Combination product1 therapeutic dose combined platelet contained no less than 2.5 ×10\^11 platelets as a quality standard.
Treatment groups
86 Participants
are divided into 1 treatment groupGroup A: Experimental groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Efficacy evaluation of combined platelet transfusion
The platelet count was measured before blood transfusion and 1 hour and 24 hours after blood transfusion, and the WHO bleeding grade was recorded. The platelet incremental correction index ( CCI ) was calculated at 1 hour and 24 hours after infusion. CCI \> 7.5 at 1 hour, CCI \> 4.5 at 24 hours, or the control or improvement of WHO bleeding symptoms after infusion were effective for infusion. CCI = ( PLT after infusion-PLT before infusion ) × body surface area ( m2 ) × 1000 / total platelet count ( × 1011 ), body surface area = 0.0061 × height ( cm ) + 0.0128 × weight ( Kg ) - 0.1529. PPR ( % ) = ( PLT after infusion-PLT before infusion ) × blood volume ( L ) × 100 % / total platelet count × 2 / 3, blood volume = 0.07 × body weight ( Kg ).
Time frame
From the start of infusion of combined platelets to 6 months laterSecondary outcomes
1
Adverse reactions of blood transfusion
During and after blood transfusion, the occurrence time, type, treatment and recovery time of adverse reactions of blood transfusion were collected and recorded, as well as the occurrence time, type, treatment and recovery time of adverse events of blood transfusion.
Time frame
From the start of infusion of combined platelets to 6 months later2
Safety evaluation of combined platelet transfusion
Blood transfusion-related infectious markers ( HBsAg, HBV DNA, anti-HCV, HCV RNA, HIV Ag / Ab, HIV RNA, anti-TP ) were detected before and after the last blood transfusion.
Time frame
From the start of infusion of combined platelets to 6 months later3
Platelet antibody screening
Platelet antibodies of the subjects were screened before blood transfusion and at the end of the intermediate follow-up period during infusion.
Time frame
From the start of infusion of combined platelets to 6 months later4
Adverse events of blood transfusion
The occurrence of adverse transfusion events in the whole process of combined platelet transfusion : time, place, type, measures and consequences.
Time frame
From the start of infusion of combined platelets to 6 months laterSponsors and contacts
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Source ClinicalTrials.gov