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

Vastra Gotaland Region

Status: Completed

Conditions: Sarcoma; Melanoma

Treatments: Drug: Crystalloid based prime solution; Drug: Erythrocyte based prime solution

Study type: Interventional

Funder types: Other

Identifiers

NCT03073304

ILP-Prime

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

Control

Active Comparator group

Description:

Erythrocyte based prime solution

Treatment:

Drug: Erythrocyte based prime solution

Intervention

Experimental group

Description:

Crystalloid based prime solution

Treatment:

Drug: Crystalloid based prime solution