Clinical Trials Register

Summary
EudraCT Number:	2011-005734-18
Sponsor's Protocol Code Number:	VOLU-011-CP4
National Competent Authority:	UK - MHRA
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2012-06-07
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

UK - MHRA

A.2

EudraCT number

2011-005734-18

A.3

Full title of the trial

Prospective randomised controlled open-label explorative multi-centre pilot trial of Volulyte®-supplemented versus Albumin-supplemented fluid resuscitation for major burns

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Volulyte®-supplemented versus Albumin-supplemented fluid resuscitation in patients suffering from burns injury

A.4.1

Sponsor's protocol code number

VOLU-011-CP4

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Fresenius Kabi Deutschland GmbH
B.1.3.4	Country	Germany
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Fresenius Kabi Deutschland GmbH
B.4.2	Country	Germany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Fresenius Kabi Deutschland GmbH
B.5.2	Functional name of contact point	BC Pharmaceuticals Clinical Affairs
B.5.3	Address:
B.5.3.1	Street Address	Else-Kroener-Strasse 1
B.5.3.2	Town/ city	Bad Homburg
B.5.3.3	Post code	61352
B.5.4	Telephone number	+49061726867324
B.5.5	Fax number	+49061726868749
B.5.6	E-mail	Daniela.Baus@fresenius-kabi.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Volulyte 6% Solution for Infusion
D.2.1.1.2	Name of the Marketing Authorisation holder	Fresenius Kabi Limited
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Albunorm 5%, 50g/l, solution for infusion
D.2.1.1.2	Name of the Marketing Authorisation holder	Octapharma Limited
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	Yes
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

patients with major burns

E.1.1.1

Medical condition in easily understood language

patients suffering from burns injury

E.1.1.2

Therapeutic area

Diseases [C] - Injuries, poisonings, and occupational diseases [C21]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

This explorative pilot study will compare two burns fluid resuscitation regimes (supplementation with 6% HES 130/0.4 in an isotonic electrolyte solution, Volulyte 6%, versus supplementation with HSA 50g/L) on outcome with particular regard to fluid balance at 24 hours after burns injury (primary variable).

E.2.2

Secondary objectives of the trial

Key secondary objectives are to compare the development of oedema, urine output, haemodynamics, bladder pressure, the use of vasoactive and inotropic drugs, and fluid balance at different time points throughout the study. Furthermore, the study will obtain patient outcome data as well as safety data.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male or female patients ≥18 years of age
2. 15%≥ Burn TBSA Injury ≤60%
3. Signed written informed consent from patient or legal representative

E.4

Principal exclusion criteria

1. Patient age >80 years
2. Delay of patient randomisation >8 hours post-burn
3. Known pregnancy (for female patients with childbearing potential a pregnancy test must be obtained as soon as possible after enrolment and in case of pregnancy, a patient must be excluded from this clinical study)
4. Known renal failure with oliguria or anuria not related to hypovolaemia (e.g. patients receiving dialysis treatment)
5. Known or suspected hypersensitivity to hydroxyethyl starch (such as rash), including its ingredients (including corn) and related drugs
6. Known or suspected allergy to human albumin preparations, including its ingredients and related drugs
7. High voltage electrical conduction injury
8. Known severe liver disease
9. Known fluid overload (hyperhydration), especially in cases of pulmonary oedema and congestive cardiac failure (patients presenting with a fluid overload on admission due to initial fluid therapy may be included at the discretion of the investigator)
10. Intracranial bleeding (known active or suspicion of intracranial bleeding)
11. Participation in another interventional clinical study within 30 days prior to enrolment

E.5 End points

E.5.1

Primary end point(s)

Cumulative fluid balance

E.5.1.1

Timepoint(s) of evaluation of this end point

at 24 hours after burns injury

E.5.2

Secondary end point(s)

Key secondary endpoints:
- Cumulative fluid balance (input-output)
- Oedema monitoring: patient’s weight, circumference measurement of unburned limb
- Urine output
- Haemodynamics: HR, BP, MAP, CVP
- Bladder pressure
- Vasoactive and inotropic drugs

E.5.2.1

Timepoint(s) of evaluation of this end point

Cumulative fluid balance (input-output):
at 8 hours after burns injury, at 24 hours after randomisation, and
until day 7 (144±12 hours after burns injury);
Oedema monitoring:
once daily until day 7 after burns injury;
Urine output:
hourly until 24 hours after burns injury, at 24 hours after randomisation and, therafter, once daily until day 7 after burns injury;
Haemodynamics:
hourly until 24 hours after burns injury, at 24 hours after randomisation and, therafter, 4 times daily until day 7 after burns injury;
Bladder pressure:
once daily until day 7 after burns injury;
Vasoactive and inotropic drugs:
until 24 hours after randomisation;

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

multi-centre, pilot

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2012-06-07.

Yes

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

Yes

F.3.3.6

Subjects incapable of giving consent personally

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

A waiver will be required (in accordance with the local ethical guidelines) to permit enrolment of unconscious patients in an emergency situation, where consent is sought from the legal representative prior to enrolment.

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2012-06-13

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-07-23

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2013-09-13

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