26
Participants
Start Date
July 22, 2021
Primary Completion Date
December 31, 2024
Study Completion Date
December 31, 2024
Purastat Arm
"Generic name of device and principal intended use(s):~Still PuraStat from a CE mark perspective. PuraStat is an aqueous self-assembling peptide solution of 2.5% concentration RADA16~Indication for use:~PuraStat is indicated for haemostasis in the following situations encountered during surgery, when haemostasis by ligation or standard means is insufficient or impractical:~* Bleeding from small blood vessels and oozing from capillaries of the parenchyma of solid organs. Oozing from vascular anastomoses~* Bleeding from small blood vessels and oozing from capillaries of the GI tract following surgical procedures~* Reduction of delayed bleeding following gastrointestinal endoscopic submucosal dissection (ESD) procedures in the colon."
Standard Care Arm
Sucralfate enemas 2g twice daily for 8 weeks, this is standard care in patients with haemorrhagic radiation proctopathy in the short term
Manchester University NHS Foundation Trust, Manchester
National Institute for Health Research, United Kingdom
OTHER_GOV
Manchester University NHS Foundation Trust
OTHER_GOV