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

Not Applicable

Completed

• Conditions: Melanoma; Sarcoma
• Interventions: Drug: Crystalloid based prime solution; Drug: Erythrocyte based prime solution

• Registration Number: NCT03073304
• Lead Sponsor: Vastra Gotaland Region

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-24
• Study First Submitted: 2017-02-28
• Study First Submitted QC: 2017-03-02
• Study First Posted: 2017-03-08
• Primary Completion: 2018-02-20
• Study Completion: 2018-04-20
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-25
• Last Update Posted: 2024-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Crystalloid based prime solution	Crystalloid based prime solution
Control	Erythrocyte based prime solution	Erythrocyte based prime solution

Primary Outcome Measures

Name	Time	Method
Lactate level during and after perfusion.	1 hour	Lactate level during and after perfusion.

Secondary Outcome Measures

Name	Time	Method
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.
Complications	30 days	Serious Adverse Events (SAEs) level III-V within 30 days.
Oxygen extraction during, and after perfusion.	1 hour	Oxygen extraction during, and after perfusion.
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

Trial Locations

Locations (1)

Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden