PerClot compared to usual care in gynaecology
| 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
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
Scientific
Bramley House
The Guildway
Old Portsmouth Road
Guildford
GU31LR
United Kingdom
| Phone | +44 (0)7551 154873 |
|---|---|
| mcelhinney.kerry@cryolife.com |
Study information
| Study design | Randomized multicentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | A prospective, multicentre, randomized, safety and effectiveness study of PerClot compared to usual care during gynaecology procedures |
| Study objectives | To 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) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | Achievement of haemostasis measured in minutes |
| Secondary outcome measures | Absence of reintervention for post operative bleeding |
| Overall study start date | 01/03/2015 |
| Completion date | 31/01/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 90 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/10/2015 |
| Date of final enrolment | 21/07/2017 |
Locations
Countries of recruitment
- Italy
- Spain
Study participating centres
00168
Italy
Barcelona
08907
Spain
Sponsor information
Industry
Bramley House
The Guildway
Old Portsmouth Road
Guildford
GU3 1LR
United Kingdom
| Phone | +44 01483 458 860 |
|---|---|
| mcelhinney.kerry@cryolife.com | |
"ROR" |
https://ror.org/05972na11 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/12/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Intention to publish in a peer reviewed journal. |
| IPD sharing plan | 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 |
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.
