Comparison of Multigam IV (5% vs. 10%) as Substitution Therapy in Patients With an Immunodeficiency Secondary to a Hematological Disorder to Evaluate Infusion Time, Tolerance and Satisfaction. A Monocentric Observational Belgian Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Infusion Time of Multigam IV 5% and Multigam IV 10%
研究概览
简要总结
The purpose of this observational study is to compare the administration of standard of care Multigam IV 5% and standard of care Multigam IV 10% in order to observe changes in infusion time and infusion related reactions. Patient satisfaction, number of actions taken by the nursing staff during infusion and satisfaction of the nursing staff will also be evaluated.
详细描述
Given the growing number of patient contacts at our day-care center, there is a continuous search to further improve the flow and to shorten the time spent per patient at the day-care center, without loss of quality in care.
In order to achieve this goal, this study wants to compare the administration of Multigam IV 5% and Multigam IV 10%. Multigam 5% and Multigam 10% are immunoglobulin solutions that are administered to strengthen the body's natural defense system (immune system). In case of recurrent infections, patients with an immunodeficiency secondary to a hematologic disorder can be treated with immunoglobulin substitution therapy. Patients can receive Multigam IV 5% and Multigam IV 10% in daily clinical practice and will receive both formulations in the same manner and intensity, meaning their use is not limited to this study.
For this observational study, patients with an immunodeficiency secondary to a hematologic disorder will be evaluated for inclusion. Patient characteristics, infusion time, time spent at the day-care center, adverse events and number of actions taken by the nursing staff will be evaluated for Multigam 5% administration. After 3-4 weeks, patients will return for Multigam 10% administration and an identical evaluation will take place along with a questionnaire for the patient and nursing staff to assess their satisfaction. The results will be processed to compare and evaluate the administration of both immunoglobulin solutions.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age => 18 years
- •Immunodeficiency secondary to a hematologic disorder
- •Patient has received at least 2 Multigam IV 5% administrations
- •Patient may not have had any adverse events (grade 2 or higher according to CTCAE v4.03) during the last 2 Multigam IV 5% administrations
- •Patient needs at least 2 more immunoglobulin administrations
- •Signed informed consent
排除标准
- •Patient has received less than 2 Multigam IV 5% administrations
- •Patient has had an adverse event (grade 2 or higher according to CTCAE v4.03) during the last 2 Multigam IV 5% administrations
- •Refusal to sign informed consent
结局指标
主要结局
Infusion Time of Multigam IV 5% and Multigam IV 10%
时间窗: Up to 1 month after Multigam 5% infusion
Comparison of infusion time between Multigam (MG) IV 5% and Multigam IV 10%. Results will be assessed by Student's-t-test and 95% confidence interval.
次要结局
- Hospitalisation Time of Multigam IV 5% and Multigam IV 10%(Up to 1 month after Multigam 5% infusion)
- Nursing Actions Per Patient During Multigam IV 5% and Multigam IV 10% Administration(During each infusion (up to 1 day))
- IVIg-related Adverse Events Per Patient During Multigam IV 5% and Multigam IV 10% Administration(Up to 72 after each infusion)
- Patient Satisfaction Questionnaire.(End of study (after Multigam 10% infusion))