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

Vastra Gotaland Region1 site in 1 country18 target enrollmentFebruary 24, 2017

ConditionsMelanoma Sarcoma

InterventionsErythrocyte based prime solution Crystalloid based prime solution

DrugsCrystalloid based prime solution Erythrocyte based prime solution

Overview

Phase: N/A
Intervention: Erythrocyte based prime solution
Conditions: Melanoma
Sponsor: Vastra Gotaland Region
Enrollment: 18
Locations: 1
Primary Endpoint: Lactate level during and after perfusion.
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 24, 2017

End Date

April 20, 2018

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Vastra Gotaland Region

Responsible Party

Principal Investigator

Roger Olofsson Bagge

Associate professor

Sahlgrenska University Hospital, Sweden

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

Not provided

Arms & Interventions

Control

Erythrocyte based prime solution

Intervention: Erythrocyte based prime solution

Intervention

Crystalloid based prime solution

Intervention: Crystalloid based prime solution

Outcomes

Primary Outcomes

Lactate level during and after perfusion.

Time Frame: 1 hour

Lactate level during and after perfusion.

Secondary Outcomes

Arterial oxygen and regional venous oxygen saturation during and after completion of perfusion.(1 hour)
Hematocrit during and after completion of perfusion.(1 hour)
Complications(30 days)
Oxygen extraction during, and after perfusion.(1 hour)
Immunological effects(30 days)