Aims
Non-variceal gastrointestinal bleeding is a common condition worldwide with an annual incidence of between 50 to 150 per 100,000. Despite improvements in diagnosis and treatment, it remains a clinical challenge, with a 30-day mortality of up to 11%. RADA16 is a novel haemostat, with no risk of thermal injury or perforation. It is applied endoscopically as a transparent hydrogel, physically preventing further bleeding. This case series aims to explore the expanded use of RADA16 in the management of non-ulcer, non-variceal bleeding.
Methods
A retrospective evaluation was undertaken at a busy, tertiary university hospital, that has a high rate of refractory bleeding. Data were collected from Welsh Clinical Portal and Synapse Clinical Workflow Manager (CWM) in patients who underwent RADA16 treatment for non-ulcer, non-variceal bleeding between 2014 – June 2025. Aetiology of bleeding, haemoglobin level, other haemostatic treatments, number of endoscopies and outcome (haemostasis achieved or rebleeding) were recorded. Endoscopic images were also taken for analysis.
Results
RESULTS: A total of eight patients were treated (Table 1), mean age 69 (SD=9), male to female ratio 6:2. Initial haemostasis was achieved in eight (100%) patients, five (62.5%) of whom had experienced failure of other haemostatic therapies. Rebleeding occurred in three (37.5%) cases. The average increase in haemoglobin on hospital admission and one month after initial treatment with RADA16 was 25.4g/L. A dependent-samples t-test indicates there was a significant difference between haemoglobin on admission (M = 80.3, SD = 22.8) and after RADA16 treatment (M = 105.7, SD = 20.2), t(6) = 3.6, p= .012. The eta squared statistic (.68) indicated a large effect size. The average decrease in number of endoscopies and treatments was 3.0 and 1.28 respectively.
|
Cases |
Age |
Sex |
Aetiology of bleeding |
Procedure type |
Co-morbidities |
|
1 |
51 |
M |
GAVE |
Endoscopy |
T2DM, Cirrhosis |
|
2 |
65 |
F |
GAVE |
Endoscopy |
Liver Steatosis, Liver Fibrosis, Acquired Hypothyroidism, Bilateral Internal Jugular Vein Thrombosis, Portal Vein thrombosis |
|
3 |
65 |
F |
GAVE |
Endoscopy |
T2DM, Hypertension, NAFLD |
|
4 |
66 |
M |
RAVE |
Sigmoidoscopy |
Malignant Neoplasm of the Prostate |
|
5 |
68 |
M |
Post-Radiotherapy Angiodysplasia |
Endoscopy |
T2DM, Hodgkins Lymphoma, Atrial fibrillation, Acute Renal Failure, Gout |
|
6 |
73 |
M |
GAVE |
Endoscopy |
Congestive Hepatopathy, Cirrhosis, Epilepsy, Hypertension, Atrial Fibrillation |
|
7 |
78 |
M |
Post-Endoscopic Therapy Bleed |
Endoscopy |
Cirrhosis, Oesophageal Varices, Subarachnoid Haemorrhage |
|
8 |
83 |
M |
GAVE |
Endoscopy |
NAFLD, Advanced fibrosis, T2DM |
Table 1: Summary of Cases Treated with RADA16
GAVE: Gastric Antral Vessel Ectasia, T2DM: Type 2 Diabetes Mellitus, NAFLD: Non-Alcoholic Fatty Liver Disease, RAVE: Radiation-Associated Vascular Ectasia
Conclusions
RADA16 is effective in achieving haemostasis in various bleeding aetiologies. Its transparency, low risk and ease of use are advantages, though further prospective studies are required to confirm its efficacy in comparison to other treatments.