Analysis results General project concept
Annually the number of children after complicated methotrexate chemotherapy in our center reaches up to 30 people, and this problem is fraught with lethal outcome. Traditional calcium folinate treatment and plasmapheresis in children do not solve the problem of methotrexate complications and sepsis. Comparative analysis of methotrexate complications before and after using the new method will reveal the relevance of the research project. It is necessary to determine when to start hemoperfusion, indications and contraindications, which method to use, duration and frequency of the session, effectiveness criteria. Hemoperfusion with HA230,330 absorbers in the complex treatment of complicated chemotherapy can reduce the toxic effect of methotrexate and improve the survival of oncological patients.
Aim of the project:
Reducing the increased concentration of methotrexate in the blood of children after chemotherapy and improving the survival of oncological patients by introducing hemoperfusion into the wide clinical practice using HA230,330 absorbers.
Objectives of the project:
1. Study the frequency and type of complications of methotrexate chemotherapy in 2019-2020.
2. Study the effectiveness of HA230,330 absorbers in the complex treatment of complications of high-dose methotrexate chemotherapy in children throughout the project.
3. Develop and implement additions to the current Protocol for the detection and diagnosis of early and late complications in children after chemotherapy.
4. Determine the method of selection, indications and contraindications for hemoperfusion using HA230,330 absorbers, the duration and frequency of the session, the criteria for effectiveness in the treatment of toxic complications.
5. Identify the advantages and disadvantages of hemoperfusion using HA230,330 absorbers.
Results:
1) This method of treatment will reveal the relevance and solve the problem of complicated chemotherapy with methotrexate in children with an oncological profile.
2) Hemoperfusion with absorbers HA 230, 330 feasible and specific work. It is safe, affordable and the project itself is easy to understand, realistic.
3) The cost-effectiveness of this hemoperfusion will allow the introduction of HA230,330 absorbers both in developed and devolving countries.
4) The frequency and type of complications of chemotherapy with methotrexate for 2019-2020 were studied.
5) A general comparative characteristic of the effectiveness of treatment of complications after high-dose chemotherapy with methotrexate for the period 2020-2021 has been carried out. (in hospital stay, antibacterial drugs, doses, frequency).
6) A comparative assessment of the hospital costs for a patient with a hemoperfusion session with HA 230.330 and a patient without hemoperfusion (case history numbers are indicated) for the period 2019-2021 is given.
7) Confirmed economic benefit with hemoperfusion in 2021 versus 2020
8) The urgency of the problem of complicated chemotherapy with methotrexate has been proved.
9) The effectiveness of HA 230.330 absorbers in the complex treatment of complications of high-dose chemotherapy with methotrexate in children was studied throughout the project.
10) The advantages and disadvantages of using hemoperfusion have been identified.
11) The problems of complicated chemotherapy with methotrexate in children with an oncological profile have been disclosed.
12) Issues related to the transfer of patients with delayed methotrexate clearance and sepsis are resolved in a timely manner.
13) Introduced laboratory monitoring of patients who received high-dose chemotherapy.
14) Continuous monitoring of all side effects of hemoperfusion after high-dose chemotherapy with methotrexate has been established.
15) The technical simplicity of the new method has been proven: hemoperfusion with the help of HA230,330 absorbers is available and safe.
16) Work is underway to develop and introduce an addition to the current protocol for the detection and diagnosis of early and late complications in children after chemotherapy.
17) New criteria have been developed and approved for the transfer of patients with an oncological profile to the Department of Pediatric Anesthesiology, Intensive Care and Intensive Care (with an operating unit).
18) The criteria for hemoperfusion with the help of HA 230, 330 absorbers in the treatment of complications of chemotherapy in children with an oncological profile have been developed and approved.
19) The method of choice, indications and contraindications of hemoperfusion with the help of HA 230.330 absorbers, the duration and frequency of the session have been determined.
20) Criteria of effectiveness in the treatment of toxic complications are presented.
21) Hemoperfusion with absorbers HA 230,330 is effective in a short period of time 4 hours,
22) Solved the problem of high-dose chemotherapy with methotrexate.
23) The basic principles of the technical performance of hemoperfusion have been compiled.
24) Possible risks of the new method are indicated.
Publications:
1) Sazonov V., Tobylbayeva Z., Saparov A., Jubaniyazov B., Issakov S., Gaipov А // New Therapeutic Approach to Reduce Methotrexate Toxicity after High-Dose Chemotherapy in a Child with Acute Lymphocytic Leukemia: Efficacy and Safety of Hemoadsorption with HA-230 Adsorber. – 2021 Blood Purification, https://doi.org/10.1159/000514135 cISSN: 0253-5068 (Print) eISSN: 1421-9735 (Online) https://www.karger.com/BPU
2) Vitaliy Sazonov, Ramazan Abylkassov, Zaure Tobylbayeva, Askhat Saparov, Olga Mironova and Dimitri Poddighe // . Efficacy and Safety of Hemoadsorption With HA-330 Adsorber in Septic Pediatric Patients With Cancer. – Frontiers Pediatric 11 June 2021 https://doi.org/10.3389/fped.2021.672260 Case Series/
Copyright certificates:
1) Certificate of entering information into the state register of rights to objects protected by copyright No. 10858 dated June 15, 2020- “The first successful application of the HA330 system in the fight against sepsis in a hematological patient at the age of 6 months.” Saparov A.I., Tobilbaeva Z.S., Isakov S.E., Mironova O.A., Karina G.B. (State register of rights to objects).
2) Certificate of entering information into the state register of rights to objects protected by copyright No. 11841 dated September 3, 2020 – “An innovative approach to the complex elimination of methotrexate after complicated chemotherapy in children: hemoperfusion using the HA230 system (Jafron, China)”. Saparov A.I., Sazonov V.G., Tobylbaeva Z.S., Dzhubaniyazov B.T., Zhusipov B.P., Kakenov E.K., Isakov S.E. (State register of rights to objects).
Research team member IDs:
1. Konkayev А.К. – ORCID 0000-0002-3778-7877; Scopus 57189606878; Researcher ID AAP-6947-2020
2. Saparov А.I.- Scopus 57205453511
3. Tobylbayeva Z.S. – ORCID 0000-0002-9047-8598; Scopus 57222506546
4. Sazonov V.G.- ORCID 0000-0003-0437; Scopus 57204784058
5. Isakov S.Y.- Scopus 57222510046
6. Kakenov Y.К. – ORCID 0000-0002-7355-3197
7. Muratbekova B.M – ORCID 0000-0001-7404-7520