A Randomized Controlled Study Comparing Priming Solution Containing Crystalloid or Packed Red Blood Cells in Patients Treated With Isolated Limb Perfusion.

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03073304

Acronym

ILP-Prime

Enrollment

Registered

2017-03-08

Start date

2017-02-24

Completion date

2018-04-20

Last updated

2024-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma, Sarcoma

Keywords

isolated limb perfusion

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.

Interventions

DRUGCrystalloid based prime solution

Crystalloid based prime solution

DRUGErythrocyte based prime solution

Erythrocyte based prime solution

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. The patient scheduled for treatment with isolated hyperthermic perfusion 2. Age over 18 years. 3. Signed informed consent

Design outcomes

Primary

Measure	Time frame	Description
Lactate level during and after perfusion.	1 hour	Lactate level during and after perfusion.

Secondary

Measure	Time frame	Description
Arterial oxygen and regional venous oxygen saturation during and after completion of perfusion.	1 hour	Arterial oxygen and regional venous oxygen saturation during and after completion of perfusion.
Hematocrit during and after completion of perfusion.	1 hour	Hematocrit during and after completion of perfusion.
Oxygen extraction during, and after perfusion.	1 hour	Oxygen extraction during, and after perfusion.
Complications	30 days	Serious Adverse Events (SAEs) level III-V within 30 days.
Immunological effects	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

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026