A Randomized Controlled Study Comparing Priming Solution Containing Crystalloid or Packed Red Blood Cells in Patients Treated With Isolated Limb Perfusion. (ILP-Prime)
January 25, 2024 updated by: Roger Olofsson Bagge, Vastra Gotaland Region
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
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Gothenburg, Sweden, 413 45
- Sahlgrenska University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- The patient scheduled for treatment with isolated hyperthermic perfusion
- Age over 18 years.
- Signed informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control
Erythrocyte based prime solution
|
Erythrocyte based prime solution
|
|
Experimental: Intervention
Crystalloid based prime solution
|
Crystalloid based prime solution
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lactate level during and after perfusion.
Time Frame: 1 hour
|
Lactate level during and after perfusion.
|
1 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Arterial oxygen and regional venous oxygen saturation during and after completion of perfusion.
Time Frame: 1 hour
|
Arterial oxygen and regional venous oxygen saturation during and after completion of perfusion.
|
1 hour
|
|
Hematocrit during and after completion of perfusion.
Time Frame: 1 hour
|
Hematocrit during and after completion of perfusion.
|
1 hour
|
|
Oxygen extraction during, and after perfusion.
Time Frame: 1 hour
|
Oxygen extraction during, and after perfusion.
|
1 hour
|
|
Complications
Time Frame: 30 days
|
Serious Adverse Events (SAEs) level III-V within 30 days.
|
30 days
|
|
Immunological effects
Time Frame: 30 days
|
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
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 24, 2017
Primary Completion (Actual)
February 20, 2018
Study Completion (Actual)
April 20, 2018
Study Registration Dates
First Submitted
February 28, 2017
First Submitted That Met QC Criteria
March 2, 2017
First Posted (Actual)
March 8, 2017
Study Record Updates
Last Update Posted (Estimated)
January 26, 2024
Last Update Submitted That Met QC Criteria
January 25, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ILP-Prime
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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