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

Sponsor

Sahlgrenska University Hospital, Sweden (Other)

Overall Status

Completed

CT.gov ID

NCT03073304

Collaborator

(none)

Enrollment

Location

Arms

13.8

Actual Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Melanoma Sarcoma	Drug: Crystalloid based prime solution Drug: Erythrocyte based prime solution	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Feb 24, 2017

Actual Primary Completion Date :

Feb 20, 2018

Actual Study Completion Date :

Apr 20, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Control Erythrocyte based prime solution	Drug: Erythrocyte based prime solution Erythrocyte based prime solution
Experimental: Intervention Crystalloid based prime solution	Drug: Crystalloid based prime solution Crystalloid based prime solution

Arm

Intervention/Treatment

Active Comparator: Control

Erythrocyte based prime solution

Drug: Erythrocyte based prime solution

Erythrocyte based prime solution

Experimental: Intervention

Crystalloid based prime solution

Drug: Crystalloid based prime solution

Crystalloid based prime solution

Outcome Measures

Primary Outcome Measures

Lactate level during and after perfusion. [1 hour]
Lactate level during and after perfusion.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sahlgrenska University Hospital	Gothenburg		Sweden	413 45

Sponsors and Collaborators

Sahlgrenska University Hospital, Sweden

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Roger Olofsson Bagge, Associate professor, Sahlgrenska University Hospital, Sweden

ClinicalTrials.gov Identifier:

NCT03073304

Other Study ID Numbers:

ILP-Prime

First Posted:

Mar 8, 2017

Last Update Posted:

Apr 20, 2018

Last Verified:

Apr 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Roger Olofsson Bagge, Associate professor, Sahlgrenska University Hospital, Sweden

isolated limb perfusion

Additional relevant MeSH terms:

Melanoma

Sarcoma

Pharmaceutical Solutions

Study Results

No Results Posted as of Apr 20, 2018