Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06421389
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-20
First Post:
2024-05-14
Brief Title:
Precise Endoscopic Application of Tranexamic Acid and Sucralfate in Gastrointestinal Bleeding A Randomized Controlled Trial
Sponsor:
National Cheng-Kung University Hospital
Organization:
National Cheng-Kung University Hospital
Study Overview
Official Title:
Precise Endoscopic Application of Tranexamic Acid and Sucralfate in Gastrointestinal Bleeding A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background and Aim Gastrointestinal bleeding GIB is a common problem in the hospital GIB can be divided into upper GIB small bowel bleeding and lower GIB Endoscopic hemostasis includes epinephrine injection hemoclipping heat probe coagulation and Argon plasma coagulation Although the successful hemostasis rate is high recurrent bleeding can occur ranging from 10 to 50 according to the bleeding etiology Therefore how to reduce the rebleeding of GIB is an important clinical issue
Methods This is a randomized clinical trial Patients with gastrointestinal bleeding for endoscopy screening and treatment at National Cheng Kung University Hospital were enrolled The study will recruit 60 patients After randomization 30 patients will be classified into the intervention group and 30 into the control group The participants will receive standard endoscopic hemostasis by either local injection of diluted epinephrine heater probe coagulation hemoclipping or band ligation After then we will spray 2g of sucralfate powder and 1g of tranexamic acid through duodenoscopy precisely on the bleeding site in the intervention group All enrolled patients will be monitored for rebleeding for 28 days after the first endoscopy
Methods This is a randomized clinical trial Patients with gastrointestinal bleeding for endoscopy screening and treatment at National Cheng Kung University Hospital were enrolled The study will recruit 60 patients After randomization 30 patients will be classified into the intervention group and 30 into the control group The participants will receive standard endoscopic hemostasis by either local injection of diluted epinephrine heater probe coagulation hemoclipping or band ligation After then we will spray 2g of sucralfate powder and 1g of tranexamic acid through duodenoscopy precisely on the bleeding site in the intervention group All enrolled patients will be monitored for rebleeding for 28 days after the first endoscopy
Detailed Description:
Gastrointestinal bleeding GIB is a common problem in the hospital The annual rate of hospitalization for any type of GI hemorrhage is estimated to be 350 hospital admissions100000 population GIB can be divided into upper GIB small bowel bleeding and lower GIB Approximately 50 of admissions for GIB are for UGI bleeding from the esophagus stomach and duodenum 40 are for LGI bleeding from the colon and anorectum and 10 are for small intestine bleeding Ulceration bleeding variceal bleeding angiodysplasia Dieulafoy lesion and tumor bleeding are common cause for UGIB while diverticulosis colitis angioectasia cancer bleeding and polypectomy ulcer attribute to the LGIB GI endoscopy can identify the bleeding site and permit therapeutic hemostasis in most patients with GI bleeding
Endoscopic hemostasis includes epinephrine injection hemoclipping heat probe coagulation and Argon plasma coagulation Although the successful hemostasis rate is high recurrent bleeding can occur ranging from 10 to 50 according to the bleeding etiology Therefore how to reduce the rebleeding of GIB is an important clinical issue
Tranexamic acid TXA is a well-known antifibrinolytic agent that inhibits fibrin degradation by binding to tissue plasminogen thereby preventing blood clot lysis and reducing bleeding A recent study evaluating the effect of topical tranexamic acid TXA powder on bleeding peptic ulcers demonstrated that the precise endoscopic administration of TXA powder can enhance the stop-bleeding effect
Sucralfate a complex of aluminum hydroxide and sucrose octa sulfate can bind to the wound base This protective barrier can prevent the wound from further environmental injury Sucralfate has been widely used for wounds and ulcer treatment eg skin wounds oral ulcers and peptic ulcers With the protective effect of the papilla mucosa sucralfate can cover the wound and has the potential to avoid further environmental damage In combination with TXA powder in stabilizing the clotting we expect the rebleeding event will reduce Therefore this study aimed to investigate whether the combination therapy of topical administration of TXA and sucralfate after standard endoscopic hemostasis can reduce the rebleeding event
Furthermore the adhesion time of the hemostasis powder at the bleeding site is also an unknown issue High-dose barium enema use provides better clinical outcomes for initial hemostasis and long-term prevention of rebleeding than conservative therapy in LGIB In combination of barium the position of hemostasis powder can be identified by Xray
Subjects and protocols Participants will be recruited from the volunteers with gastrointestinal bleeding at National Cheng Kung University Hospital Eligible participants include patients aged 18 years who accept endoscopy for GIB including hematemesis Tarry stool or bloody stool Patient consent forms will be given and explained to all patients before the endoscopy Exclusion criteria include patients with no need of endoscopic hemostasis allergy to sucralfate tranexamic acid or barium pregnancy and patients with hollow organ perforation After patient enrollment we will randomize the patient into either the intervention group or control group by sealed envelope randomization method
After the standard endoscopic hemostasis by either epinephrine injection hemoclipping heat coagulation or band ligation we will randomly assign the patients to either a control or an intervention group After then we will spray 2g of sucralfate powder 1g of tranexamic acid powder and 1g of barium through the endoscopy precisely on the bleeding site in the intervention group
Blood tests As ward routine for bleeding patient a blood sample is obtained to measure creatinine albumin total bilirubin hemoglobin platelet prothrombin time PT and activated partial thromboplastin time APTT All lab data are checked by the central laboratory of the National Cheng Kung University Hospital
Endoscopic hemostasis includes epinephrine injection hemoclipping heat probe coagulation and Argon plasma coagulation Although the successful hemostasis rate is high recurrent bleeding can occur ranging from 10 to 50 according to the bleeding etiology Therefore how to reduce the rebleeding of GIB is an important clinical issue
Tranexamic acid TXA is a well-known antifibrinolytic agent that inhibits fibrin degradation by binding to tissue plasminogen thereby preventing blood clot lysis and reducing bleeding A recent study evaluating the effect of topical tranexamic acid TXA powder on bleeding peptic ulcers demonstrated that the precise endoscopic administration of TXA powder can enhance the stop-bleeding effect
Sucralfate a complex of aluminum hydroxide and sucrose octa sulfate can bind to the wound base This protective barrier can prevent the wound from further environmental injury Sucralfate has been widely used for wounds and ulcer treatment eg skin wounds oral ulcers and peptic ulcers With the protective effect of the papilla mucosa sucralfate can cover the wound and has the potential to avoid further environmental damage In combination with TXA powder in stabilizing the clotting we expect the rebleeding event will reduce Therefore this study aimed to investigate whether the combination therapy of topical administration of TXA and sucralfate after standard endoscopic hemostasis can reduce the rebleeding event
Furthermore the adhesion time of the hemostasis powder at the bleeding site is also an unknown issue High-dose barium enema use provides better clinical outcomes for initial hemostasis and long-term prevention of rebleeding than conservative therapy in LGIB In combination of barium the position of hemostasis powder can be identified by Xray
Subjects and protocols Participants will be recruited from the volunteers with gastrointestinal bleeding at National Cheng Kung University Hospital Eligible participants include patients aged 18 years who accept endoscopy for GIB including hematemesis Tarry stool or bloody stool Patient consent forms will be given and explained to all patients before the endoscopy Exclusion criteria include patients with no need of endoscopic hemostasis allergy to sucralfate tranexamic acid or barium pregnancy and patients with hollow organ perforation After patient enrollment we will randomize the patient into either the intervention group or control group by sealed envelope randomization method
After the standard endoscopic hemostasis by either epinephrine injection hemoclipping heat coagulation or band ligation we will randomly assign the patients to either a control or an intervention group After then we will spray 2g of sucralfate powder 1g of tranexamic acid powder and 1g of barium through the endoscopy precisely on the bleeding site in the intervention group
Blood tests As ward routine for bleeding patient a blood sample is obtained to measure creatinine albumin total bilirubin hemoglobin platelet prothrombin time PT and activated partial thromboplastin time APTT All lab data are checked by the central laboratory of the National Cheng Kung University Hospital
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None