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Completed

NCT Number: NCT03073304

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

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.

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Key information

Conditions

Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective and Soft Tissue Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Sarcoma Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sahlgrenska University Hospital

Gothenburg, 413 45, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Crystalloid based prime solution

Drug

Crystalloid based prime solution

Erythrocyte based prime solution

Drug

Erythrocyte based prime solution

Primary outcomes

  1. Lactate level during and after perfusion.

    Time frame: 1 hour

    Lactate level during and after perfusion.

Secondary outcomes

  1. Arterial oxygen and regional venous oxygen saturation during and after completion of perfusion.

    Time frame: 1 hour

    Arterial oxygen and regional venous oxygen saturation during and after completion of perfusion.

  2. Hematocrit during and after completion of perfusion.

    Time frame: 1 hour

    Hematocrit during and after completion of perfusion.

  3. Oxygen extraction during, and after perfusion.

    Time frame: 1 hour

    Oxygen extraction during, and after perfusion.

  4. Complications

    Time frame: 30 days

    Serious Adverse Events (SAEs) level III-V within 30 days.

  5. Immunological effects

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Vastra Gotaland Region

Other Gov

Registry information

Official study 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

Acronym: ILP-Prime

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 8, 2017
Registry last updated
Jan 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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