The efficacy of Purastat for the treatment of hematuria cystitis
Research type
Research Study
Full title
The efficacy of Purastat for the treatment of persistent severe hematuria post-radiation cystitis
IRAS ID
336909
Contact name
Cristian Ilie
Contact email
Sponsor organisation
Queen Elizabeth Hospital King's Lynn Foundation Trust
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Radiation Cystitis occurs owing to inflammation and subsequent destruction to the normal anatomy of the urinary bladder at the cellular level after the use of radiation in the treatment of pelvic cancers. Late radiation cystitis can develop from 6 months to 20 years after therapy. The main presenting symptom is haematuria. While some clinical management procedures are available for severe late radiation cystitis these treatments do not cure the persistent bleeding.
PuraStat is a synthetic haemostatic material in the form of a prefilled syringe.
PuraStat is indicated for haemostasis in the following situations during surgery, when haemostasis by ligation or standard means is insufficient or impractical a) bleeding from small blood vessels and oozing from capillaries of the parenchyma and surrounding tissues of solid organs; b) oozing from vascular anastomoses to native or artificial vessels, on the surface of blood vessels and surrounding tissues; and c) bleeding from small vessels and oozing from capillaries of the GI tract and surrounding tissues.
PuraStat has been successfully used to stop bleeding during endoscopic procedures and to control rectal bleeding after radiotherapy.
Some clinicians are beginning to apply Purastat for severe persistent hematuria post radiation cystitis in their “routine” care. Since there is currently no efficacious intervention for this indication it is important to monitor the efficacy of the implementation of Purastat.
The aim of the present observational study is to monitor the real-world efficacy of Purastat for the treatment/ management of severe persistent haematuria post radiation cystitis across 6 NHS Trusts.REC name
London - Dulwich Research Ethics Committee
REC reference
23/LO/0998
Date of REC Opinion
23 Jan 2024
REC opinion
Further Information Favourable Opinion