Back to resultsA Randomized Controlled Study Comparing Priming Solution Containing Crystalloid or Packed Red Blood Cells in Patients Treated With Isolated Limb Perfusion. (ILP-Prime)
Primary Purpose
Melanoma, Sarcoma
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Crystalloid based prime solution
Erythrocyte based prime solution
Sponsored by
About this trial
This is an interventional treatment trial for Melanoma focused on measuring isolated limb perfusion
Eligibility Criteria
Inclusion Criteria:
- The patient scheduled for treatment with isolated hyperthermic perfusion
- Age over 18 years.
- Signed informed consent
Sites / Locations
- Sahlgrenska University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control
Intervention
Arm Description
Erythrocyte based prime solution
Crystalloid based prime solution
Outcomes
Primary Outcome Measures
Lactate level during and after perfusion.
Lactate level during and after perfusion.
Secondary Outcome Measures
Arterial oxygen and regional venous oxygen saturation during and after completion of perfusion.
Arterial oxygen and regional venous oxygen saturation during and after completion of perfusion.
Hematocrit during and after completion of perfusion.
Hematocrit during and after completion of perfusion.
Oxygen extraction during, and after perfusion.
Oxygen extraction during, and after perfusion.
Complications
Serious Adverse Events (SAEs) level III-V within 30 days.
Immunological effects
Changes in proportion of immune cells measured as CD3 + (T cells), CD3 + 4 + (helper T cells), CD3 + 8 + (cytotoxic T cells), CD3 + DR + (activated T cells), CD3 + 4 + 45RA + (naive helper T cells), CD3 + 8 + 45RA + (naïve cytotoxic T cells), CD3 + 4 + 45RO + (helper T cells), CD3 + 8 + 45RO + (cytotoxic memory T cells), CD3-56 + 16 + (NK cells), CD3 + 56 + 16 + (activated T cells), CD5 + (T-cells and some B-cells), CD19 + (B cells), CD5 + 19 + (subset of mature B cells mainly form polyspecific antibodies of the IgM class) will be measured before ILP, after 7 and 30 days post ILP
Full Information
NCT ID
NCT03073304
First Posted
February 28, 2017
Last Updated
April 19, 2018
Sponsor
Sahlgrenska University Hospital, Sweden
1. Study Identification
Unique Protocol Identification Number
NCT03073304
Brief Title
A Randomized Controlled Study Comparing Priming Solution Containing Crystalloid or Packed Red Blood Cells in Patients Treated With Isolated Limb Perfusion.
Acronym
ILP-Prime
Official Title
A Randomized Controlled Study With the Aim to Compare Crystalloid Prime Solution With a Prime Solution Containing Packed Red Blood Cells in Relation to the Patient's Regional Metabolic Needs and Immunological Influence During Isolated Limb Perfusion
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
February 24, 2017 (Actual)
Primary Completion Date
February 20, 2018 (Actual)
Study Completion Date
April 20, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sahlgrenska University Hospital, Sweden
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary aim of this study is to investigate the possibility to replace an erythrocyte based prime solution with a crystalloid based prime solution while maintaining metabolic function. Secondary also to study if potentially reduced immunological influence is obtained during hyper thermic isolated limb perfusion with a crystalloid based prime solution.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma, Sarcoma
Keywords
isolated limb perfusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Erythrocyte based prime solution
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Crystalloid based prime solution
Intervention Type
Drug
Intervention Name(s)
Crystalloid based prime solution
Intervention Description
Crystalloid based prime solution
Intervention Type
Drug
Intervention Name(s)
Erythrocyte based prime solution
Intervention Description
Erythrocyte based prime solution
Primary Outcome Measure Information:
Title
Lactate level during and after perfusion.
Description
Lactate level during and after perfusion.
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Arterial oxygen and regional venous oxygen saturation during and after completion of perfusion.
Description
Arterial oxygen and regional venous oxygen saturation during and after completion of perfusion.
Time Frame
1 hour
Title
Hematocrit during and after completion of perfusion.
Description
Hematocrit during and after completion of perfusion.
Time Frame
1 hour
Title
Oxygen extraction during, and after perfusion.
Description
Oxygen extraction during, and after perfusion.
Time Frame
1 hour
Title
Complications
Description
Serious Adverse Events (SAEs) level III-V within 30 days.
Time Frame
30 days
Title
Immunological effects
Description
Changes in proportion of immune cells measured as CD3 + (T cells), CD3 + 4 + (helper T cells), CD3 + 8 + (cytotoxic T cells), CD3 + DR + (activated T cells), CD3 + 4 + 45RA + (naive helper T cells), CD3 + 8 + 45RA + (naïve cytotoxic T cells), CD3 + 4 + 45RO + (helper T cells), CD3 + 8 + 45RO + (cytotoxic memory T cells), CD3-56 + 16 + (NK cells), CD3 + 56 + 16 + (activated T cells), CD5 + (T-cells and some B-cells), CD19 + (B cells), CD5 + 19 + (subset of mature B cells mainly form polyspecific antibodies of the IgM class) will be measured before ILP, after 7 and 30 days post ILP
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patient scheduled for treatment with isolated hyperthermic perfusion
Age over 18 years.
Signed informed consent
Facility Information:
Facility Name
Sahlgrenska University Hospital
City
Gothenburg
ZIP/Postal Code
413 45
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35575302
Citation
Corderfeldt Keiller A, Holmen A, Hansson C, Ricksten SE, Bragadottir G, Olofsson Bagge R. Non-invasive and invasive measurement of skeletal muscular oxygenation during isolated limb perfusion. Perfusion. 2023 Jul;38(5):1019-1028. doi: 10.1177/02676591221093201. Epub 2022 May 16.
Results Reference
derived
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A Randomized Controlled Study Comparing Priming Solution Containing Crystalloid or Packed Red Blood Cells in Patients Treated With Isolated Limb Perfusion.
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