ISRCTN ISRCTN45856014
DOI https://doi.org/10.1186/ISRCTN45856014
Secondary identifying numbers PCT1501.000-C
Submission date
03/07/2015
Registration date
15/07/2015
Last edited
22/01/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Contact information

Mrs Kerry McElhinney
Scientific

Bramley House
The Guildway
Old Portsmouth Road
Guildford
GU31LR
United Kingdom

Phone +44 (0)7551 154873
Email mcelhinney.kerry@cryolife.com

Study information

Study designRandomized multicentre trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeDiagnostic
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleA prospective, multicentre, randomized, safety and effectiveness study of PerClot compared to usual care during gynaecology procedures
Study objectivesTo demonstrate the safety and effectiveness of PerClot compared to usual care when used during gynaecology procedures
Ethics approval(s)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
Health condition(s) or problem(s) studiedGynaecology surgical procedures
InterventionHalf 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 typeDevice
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measureAchievement of haemostasis measured in minutes
Secondary outcome measuresAbsence of reintervention for post operative bleeding
Overall study start date01/03/2015
Completion date31/01/2018

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participants90
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/10/2015
Date of final enrolment21/07/2017

Locations

Countries of recruitment

  • Italy
  • Spain

Study participating centres

Gemelli Hospital
Rome
00168
Italy
Belvitge Hospital
Feixa Llarga, s/n
Barcelona
08907
Spain

Sponsor information

CryoLife Europa (UK)
Industry

Bramley House
The Guildway
Old Portsmouth Road
Guildford
GU3 1LR
United Kingdom

Phone +44 01483 458 860
Email mcelhinney.kerry@cryolife.com
ROR logo "ROR" https://ror.org/05972na11

Funders

Funder type

Industry

CryoLife Europa (UK)

No information available

Results and Publications

Intention to publish date31/12/2018
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planIntention to publish in a peer reviewed journal.
IPD sharing planThe datasets generated during and/or analysed during the current study are/will be available upon request from Kerry McElhinney at mcelhinney.kerry@cryolife.com

Editorial Notes

22/01/2018: The following changes were made:
1. Recruitment end date was changed from 30/10/2016 to 21/07/2017.
2. Overall trial end date was changed from 31/01/2017 to 31/01/2018.
3. Publication plan, participant level data and intention to publish date were added.
29/03/2016: Ethics approval information added.