A comparative study of six automated cell separators for plateletpheresis in a tertiary care cancer hospital of India.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 936
- 试验地点
- 1
- 主要终点
- 1. Procedural Variables (Procedure Duration, Total Blood Volume (TBV) Processed, Collection Efficiency, and Collection Rate; Total Anticoagulant used, Anticoagulant infused to Donor)
研究概览
简要总结
Summary of the Plateletpheresis Platform Comparison Study
This prospective observational study aims to compare six different automated cell separators—Amicus, AmiCORE, COM.TEC, Haemonetics MCS plus, Spectra Optia, and Trima Accel—based on their performance in plateletpheresis procedures, donor experience, and quality of the single donor platelet concentrate (SDPC) products. The study will be conducted at the Homi Bhabha Cancer Hospital Blood Centre, Varanasi, and will include healthy voluntary platelet donors from Varanasi and adjoining districts of Uttar Pradesh, India.
Hypothesis
Among various automated cell separators, while collecting platelets via apheresis technique, the technical parameters will be identical, the feedback of donors will be similar, the rate of adverse effects will be the same, and the quality parameters of collected single donor platelet concentrate will be analogous (H0).
Day 0: Donor Recruitment and Plateletpheresis
Prospective donors will register at the Blood Centre, undergo standard eligibility screening, and provide informed written consent. Those consenting will be randomized to one of the six apheresis platforms. Baseline donor characteristics—age, gender, height, weight—will be documented, and Total Blood Volume (TBV) and Body Surface Area (BSA) will be calculated using standard formulas. Pre-procedural hematologic parameters (CBC) will be measured.
After randomization, donors will receive calcium carbonate (500 mg elemental calcium) to prevent citrate toxicity. Plateletpheresis will be conducted as per the department’s SOP. Procedure-related variables including duration, total anticoagulant used, anticoagulant infused to the donor, blood volume processed (BVP), and calculated total blood volume processed (TBVP) will be recorded. Procedure efficiency (errors or abortions) and donor adverse events (e.g., vasovagal reactions, citrate toxicity, hematoma) will also be tracked.
Post-procedure, another CBC will be performed. Donors will then complete a 10-item structured feedback survey rated on a 5-point Likert scale, assessing their satisfaction and experience. The total score (range 10–50) will reflect the overall donor satisfaction.
Day 1: Quality Control of SDPC
On the following day, quality control testing of the collected SDPC will be conducted. Samples from the SDPC will be tested for platelet, RBC, and WBC counts. Additional parameters like volume, pH (via potentiometry), and swirling (graded visually) will be assessed. Platelet yield will be calculated, and collection efficiency (CE) and collection rate (CR) derived using standard formulas.
Data Management and Statistical Analysis
All data will be recorded in a structured Case Record Form (CRF), including donor demographics, lab parameters, procedural variables, product quality, donor adverse effects, and feedback scores. Descriptive statistics will be used to summarize the data. One-way ANOVA or Kruskal-Wallis test will compare continuous variables; Chi-square test will be used for categorical data. Regression analysis will adjust for confounders, and mixed-effects models will address operator-level or repeated measure variability. A p-value <0.05 will be considered statistically significant.
Ethics and Confidentiality
The study has ethical approval and ensures confidentiality per regulatory norms. Donors may withdraw consent at any point without any obligation. Access to data is restricted to the principal and co-investigators.
Implications
The study will help determine the most efficient and donor-friendly apheresis platform in terms of yield, product quality, safety, and satisfaction. The findings will guide device selection, SOP development, staff training, and regulatory compliance in transfusion services, especially in oncology care settings.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Donors shall be in good health, mentally alert and physically fit and shall not be inmates of jail or any other confinement.
- •Age of the Donor – minimum 18 years; maximum 60 years.
- •Weight of the Donor – 55 kg and above.
- •Donors shall have at least one prominent vein, preferably two, for easy venous access.
- •Donors who are found medically acceptable according to the Departmental Standard Operating Procedure (following the General Statutory Rules (GSR) 166(E) of 2020, and 2025 Guidelines for Blood Donor Selection and Blood Donor Referral by National Blood Transfusion Council).
- •Donors consenting to participate in the study.
- •Donors shall have at least one prominent vein, in either cubital fossa, for easy venous access.
- •Donors who donated a minimum target yield of 300 billion platelets per bag.
- •Donors from whom a post-donation sample was taken.
排除标准
- •Donor had donated platelets via apheresis within the last 48 hours.
- •Donor has donated platelets via apheresis more than 2 times in a week.
- •Donor had donated platelets via apheresis more than 24 times in a year.
- •Donation of Whole Blood within the last 7 days.
- •Reinfusion of red cells not complete during the last procedure of apheresis, done within 90 days.
- •Donor bone marrow harvest done within 12 months.
- •Donor peripheral stem cell harvest done within 6 months.
- •Blood pressure of the donor is less than 100 by 60 mmHg, or more than 140 by 90 mm Hg, with or without medications.
- •Findings in donors suggestive of end organ damage or secondary complications (cardiac, renal, eye or vascular) or history of feeling giddiness, fainting made out during history and examination.
- •Donor hearts beat less than 60, or more than 100 per minute; irregular in nature.
- •Febrile donor – temperature more than 370C.
- •Acute respiratory disease.
- •Hemoglobin less than 12.5 g per dL.
- •Platelets count less than 150 thousand per mL.
- •Last meal took more than 4 hours prior to donation.
- •Consumed alcohol and intoxicated.
- •As far as can be determined by history and examination, the donor is suspected of suffering from some disease transmissible by blood transfusion.
- •Skin diseases at the site of phlebotomy, skin punctures or needle scars indicative of addiction.
- •Asthmatic donor.
- •Pregnancy or recently delivered donor in the last 12 months.
- •Donor who had abortion in the last 6 months.
- •Donor who is breastfeeding.
- •Donor who is menstruating.
- •Donor had minor surgery in the last 3 months.
- •Donor who had open-heart surgery, by-pass surgery, and cancer surgery.
- •Donor who had tooth-extraction or dental surgery under anesthesia within the last 6 months, any other dental procedure within the last 3 days.
- •Donor who have structural or functional heart disease.
- •Migraine with frequency of more than one episode per week.
- •Donor with severe anxiety or mood disorder, not controlled by medications.
- •Donor with convulsions, epilepsy, or schizophrenia.
- •Donor on regular insulin for diabetes.
- •Donor with unknown hepatitis, known Hepatitis B and C infection.
- •Donor with Hepatitis A or E in the last 12 months.
- •Donor is spouse/ partner/ close contact for the last 12 months, of an individual suffering with hepatitis.
- •Donors who had tattoos, acupuncture or body piercing, scarification and any other invasive cosmetic procedure within the last 12 months.
- •Donor is the spouse or partner of an individual who had received transfusion of blood or components in the last 12 months.
- •Donor with history of jaundice not attributed to gallstones, Rh disease, mononucleosis or neonatal period.
- •Donor who had worked in renal dialysis in the last 12 months.
- •Donor who had received blood or component transfusion in the last 12 months.
- •Donor who is at risk of HIV infection (Transgender, Men who have Sex with Men, Female Sex Workers, Injecting drug users, persons with multiple sex partners).
- •Known HIV positive donor or spouse or partner of PLHA (person living with HIV AIDS).
- •Donor who has recovered from measles, mumps, chickenpox within the last 2 weeks.
- •Donor who has recovered from malaria within the last 3 months.
- •Donor with Leishmaniasis or Leprosy.
- •Donor who has recovered from acute kidney infection within the last 6 months.
- •Donor who has chronic kidney disease.
- •Donor who has recovered from diarrhoea with fever within the last 2 weeks.
- •Donor who had GI Endoscopy within the last 12 months.
- •Donors with autoimmune disorders like systemic lupus erythematosis, scleroderma, dermatomyositis, ankylosing spondylitis or severe rheumatoid arthritis.
- •Donor with polycythaemia vera, bleeding disorders and unexplained bleeding tendency.
- 另有 7 项未显示
结局指标
主要结局
1. Procedural Variables (Procedure Duration, Total Blood Volume (TBV) Processed, Collection Efficiency, and Collection Rate; Total Anticoagulant used, Anticoagulant infused to Donor)
时间窗: Baseline Data collected On the Day of Plateletpheresis Procedure (defined as Day 0) - Data for "Outcome 1." Procedural Variables, and "Outcome 2." Procedural Efficiency. | On the Next Day (defined as Day 1), Data for "Outcome 3." Quality Parameters of SDP Conc. will be collected.
2. Procedural Efficiency (Frequency and Nature of Errors, and Procedure Abortions)
时间窗: Baseline Data collected On the Day of Plateletpheresis Procedure (defined as Day 0) - Data for "Outcome 1." Procedural Variables, and "Outcome 2." Procedural Efficiency. | On the Next Day (defined as Day 1), Data for "Outcome 3." Quality Parameters of SDP Conc. will be collected.
3. Quality Parameters of SDP Conc. include the following (Visual Check, Swirling, Volume, Product Yield, RBC count, WBC count, pH).
时间窗: Baseline Data collected On the Day of Plateletpheresis Procedure (defined as Day 0) - Data for "Outcome 1." Procedural Variables, and "Outcome 2." Procedural Efficiency. | On the Next Day (defined as Day 1), Data for "Outcome 3." Quality Parameters of SDP Conc. will be collected.
次要结局
- 4. Donor satisfaction with the plateletpheresis procedure on each cell separator shall be evaluated using a structured questionnaire.(At Baseline, immediately after the plateletpheresis procedure.)
- 5. Incidence & type of donor adverse effects shall be documented using Donor Reaction Form (DRF, as approved & released by the National Institute of Biologicals (NIB), Government of India).(At Baseline, during or immediately after the plateletpheresis procedure.)
研究者
Dr Akshay Batra
Homi Bhabha Cancer Hospital, Tata Memorial Centre, Homi Bhabha National Institute, Varanasi, India