A Randomized Controlled Study Comparing Priming Solution Containing Crystalloid or Packed Red Blood Cells in Patients Treated With Isolated Limb Perfusion.
ILP-Prime
1 other identifier
interventional
18
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 24, 2017
CompletedFirst Submitted
Initial submission to the registry
February 28, 2017
CompletedFirst Posted
Study publicly available on registry
March 8, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 20, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 20, 2018
CompletedJanuary 26, 2024
January 1, 2024
12 months
February 28, 2017
January 25, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Lactate level during and after perfusion.
Lactate level during and after perfusion.
1 hour
Secondary Outcomes (5)
Arterial oxygen and regional venous oxygen saturation during and after completion of perfusion.
1 hour
Hematocrit during and after completion of perfusion.
1 hour
Oxygen extraction during, and after perfusion.
1 hour
Complications
30 days
Immunological effects
30 days
Study Arms (2)
Control
ACTIVE COMPARATORErythrocyte based prime solution
Intervention
EXPERIMENTALCrystalloid based prime solution
Interventions
Eligibility Criteria
You may qualify if:
- The patient scheduled for treatment with isolated hyperthermic perfusion
- Age over 18 years.
- Signed informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sahlgrenska University Hospital
Gothenburg, 413 45, Sweden
Related Publications (1)
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.
PMID: 35575302DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
February 28, 2017
First Posted
March 8, 2017
Study Start
February 24, 2017
Primary Completion
February 20, 2018
Study Completion
April 20, 2018
Last Updated
January 26, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share