Comparison of Multigam IV (5% vs. 10%) in Patients With an Immunodeficiency Secondary to a Hematological Disorder

Hematologic Diseases Clinical Trial

— MULTISIM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03250845
• Other study ID #: HEM-2017-001
• Status: Completed
• Start date: June 30, 2017
• Est. completion date: December 13, 2017

Study information

• Verified date: October 2019
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 13, 2017
• Est. primary completion date: October 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Hematologic Diseases
• Immunologic Deficiency Syndromes
• Neoplasm Metastasis
• Secondary Immune Deficiency

Locations

Country	Name	City	State
Belgium	UZ Leuven Gasthuisberg	Leuven	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infusion Time of Multigam IV 5% and Multigam IV 10%	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.	Up to 1 month after Multigam 5% infusion
Secondary	Hospitalisation Time of Multigam IV 5% and Multigam IV 10%	Comparison of hospitalisation time (time spent at day clinic) between Multigam IV 5% and Multigam IV 10%. Results will be assessed by Student's-t-test and 95% confidence interval.	Up to 1 month after Multigam 5% infusion
Secondary	IVIg-related Adverse Events Per Patient During Multigam IV 5% and Multigam IV 10% Administration	Evaluation of the occurence of adverse events (AEs) for both administrations via CTCAE v4.03 criteria.; Results are reported as the mean number of IVIg-related AEs per patient. Adverse events were actively monitored during infusion and patients could report adverse events up to 72h after infusion.	Up to 72 after each infusion
Secondary	Nursing Actions Per Patient During Multigam IV 5% and Multigam IV 10% Administration	Evaluate the number of actions taken by the nursing staff during Multigam administration. Nursing actions were defined as the sum of actions required to increase the infusion rate (if needed) and any other action that had to be taken due to adverse effects during administration (e.g. lowering of infusion rate or supportive medication). Standard procedures like taking parameters were not accounted for this evaluation.	During each infusion (up to 1 day)
Secondary	Patient Satisfaction Questionnaire.	Assess patient satisfaction via questionnaires. Questionnaires were taken at the end of MG 10% infusion and were validated by the principal investigator (PI) and head nurse.; Patients could score following questions from 1 (strongly disagree) to 5 (strongly agree) [Full scale: 1: strongly disagree; 2:disagree; 3: neutral; 4: agree; 5; strongly agree]: Question 1: I experienced less side effects during Multigam 10% infusion. Question 2: I experienced time gain with Multigam 10%. Question 3: I had a more productive day with Multigam 10%. Question 4: I am in favor of of the use of Multigam 10%.	End of study (after Multigam 10% infusion)