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NCT03073304 Clinical Trial

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

Melanoma Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03073304
Other study ID # ILP-Prime
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 24, 2017
Est. completion date April 20, 2018

Study information
Verified date January 2024
Source Vastra Gotaland Region
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 18
Est. completion date April 20, 2018
Est. primary completion date February 20, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. The patient scheduled for treatment with isolated hyperthermic perfusion 2. Age over 18 years. 3. Signed informed consent

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Crystalloid based prime solution
Crystalloid based prime solution
• Erythrocyte based prime solution
Erythrocyte based prime solution

Locations
Country Name City State
Sweden Sahlgrenska University Hospital Gothenburg

Sponsors (1)
Lead Sponsor Collaborator
Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Lactate level during and after perfusion. Lactate level during and after perfusion. 1 hour
Secondary 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. 1 hour
Secondary Hematocrit during and after completion of perfusion. Hematocrit during and after completion of perfusion. 1 hour
Secondary Oxygen extraction during, and after perfusion. Oxygen extraction during, and after perfusion. 1 hour
Secondary Complications Serious Adverse Events (SAEs) level III-V within 30 days. 30 days
Secondary 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 30 days
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