Plain English Summary
Background and study aims
PerClot is a product that has been developed to control bleeding during surgical procedures or following traumatic injuries. The overall objective of this clinical study is to collect clinical data to demonstrate the safety and effectiveness of PerClot compared to usual care when used during gynecological procedures.
Who can participate?
Women (over 18) having a gynaecological procedure.
What does the study involve?
Half the patients are randomised to receive PerClot. The other half of the patients are randomised to be given usual care which will be whatever treatment the surgeon wishes to use. The time taken for the bleeding to stop is assessed as is whether or not further measures to stop any bleeding that reoccurs after surgery is needed, whether any infection occurs and whether there are any adverse effects to the treatment.
What are the possible benefits and risks of participating?
As this is a post market study on a product already used, there are no associated risks.
Where is the study run from?
Gemelli Hospital, Rome (Italy) and Belvitge Hospital, Barcelona (Spain)
When is the study starting and how long is it expected to run for?
March 2015 to January 2018
Who is funding the study?
CryoLife Europa (UK)
Who is the main contact?
Mrs Kerry McElhinney
mcelhinney.kerry@cryolife.com
Trial website
Contact information
Type
Scientific
Primary contact
Mrs Kerry McElhinney
ORCID ID
Contact details
Bramley House
The Guildway
Old Portsmouth Road
Guildford
GU31LR
United Kingdom
+44 (0)7551 154873
mcelhinney.kerry@cryolife.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PCT1501.000-C
Study information
Scientific title
A prospective, multicentre, randomized, safety and effectiveness study of PerClot compared to usual care during gynaecology procedures
Acronym
Study hypothesis
To demonstrate the safety and effectiveness of PerClot compared to usual care when used during gynaecology procedures
Ethics approval
1. Technical and Scientific Ethics Committee, A Gemelli Catholic University of the Sacred Heart,
12/10/2015, Ref 0007342/15
2. Comite Etico de Investgacion Clinica, Hospital Universitari Bellvitge, 15/04/2015, Ref: AC096/15
Study design
Randomized multicentre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Gynaecology surgical procedures
Intervention
Half the patients will be randomised to receive PerClot. The dose will be dependent on the surface area and will usually be 3G or 5G. The other half of the patients will be randomised to receive usual care which will be whatever other haemostat the surgeon wishes to use i.e floseal, tisseal etc. If they do not use another haemostat to achieve haemostasis then diathermy may be used as an alternative. Randomisation will be either IWRS ( interactive web response system) or IVRS (interactive voice response system).
Intervention type
Device
Phase
Drug names
Primary outcome measures
Achievement of haemostasis measured in minutes
Secondary outcome measures
Absence of reintervention for post operative bleeding
Overall trial start date
01/03/2015
Overall trial end date
31/01/2018
Reason abandoned
Eligibility
Participant inclusion criteria
1. Subject is over 18
2. Subject is having a gynaecological procedure
3. Subject is willing and able to comply with the protocol
4. Subject is willing and able to give informed consent
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
90
Participant exclusion criteria
1. Subject with a history of pelvic or abdominal radiotherapy (within 8 weeks of surgery)
2. Subject is pregnant or actively breastfeeding
3. Subject has a ruptured ectopic pregnancy
4. Subject has a history of abnormal coagulopathy
5. Subject has a sensitivity to starch or starch derived materials
6. Subject has an active or potential infection at the surgical site
7. Subject is currently enrolled in another study
Recruitment start date
01/10/2015
Recruitment end date
21/07/2017
Locations
Countries of recruitment
Italy, Spain
Trial participating centre
Gemelli Hospital
Rome
00168
Italy
Trial participating centre
Belvitge Hospital
Feixa Llarga, s/n
Barcelona
08907
Spain
Sponsor information
Organisation
CryoLife Europa (UK)
Sponsor details
Bramley House
The Guildway
Old Portsmouth Road
Guildford
GU3 1LR
United Kingdom
+44 01483 458 860
mcelhinney.kerry@cryolife.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
CryoLife Europa (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Intention to publish in a peer reviewed journal.
IPD sharing statement: The datasets generated during and/or analysed during the current study are/will be available upon request from Kerry McElhinney at mcelhinney.kerry@cryolife.com
Intention to publish date
31/12/2018
Participant level data
Available on request
Results - basic reporting
Publication summary