Condition category
Surgery
Date applied
03/07/2015
Date assigned
15/07/2015
Last edited
29/03/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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 2017

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

31/01/2017

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

30/10/2016

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 date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

29/03/2016: Ethics approval information added.