NCT01717612

A Prospective, Randomized Trial of Histoacryl Injection Versus Thrombin in the Control of Acute Gastric Variceal Bleeding

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 62 (estimated)
• Sponsor: National Science and Technology Council, Taiwan · Other Government
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Though histoacryl injection is now regarded as treatment of choice in the control of gastric variceal hemorrhage, it may be associated with a lot of complications such as ulcers, ulcer bleeding, bacterial infections, distant site thrombosis and cerebral vascular accident. On the other hand, thrombin has been shown to be effective in acute hemostasis of bleeding gastric varices, ranging from 70% to 100% has been recorded. The rebleeding rates were between 7% and 50%. Moreover, the benefits of thrombin injection include safety, without inducing ulcers or ulcer bleeding. No incidence of distant thrombosis has ever been reported.

Detailed description

Previous studies have proven that the use of cyanoacrylate glue injection was superior to EIS or EVL in arresting acute gastric variceal bleeding. Endoscopic obturation with glue injection has gained worldwide popularity except the United States. The hemostatic rates of glue injection ranged from 87% to 100%, with rebleeding rates about 7% to 71%. Though histoacryl injection is now regarded as treatment of choice in the control of gastric variceal hemorrhage, it may be associated with a lot of complications such as ulcers, ulcer bleeding, bacterial infections, distant site thrombosis and cerebral vascular accident. On the other hand, thrombin has been shown to be effective in acute hemostasis of bleeding gastric varices, ranging from 70% to 100% has been recorded. The rebleeding rates were between 7% and 50%. Moreover, the benefits of thrombin injection include safety, without inducing ulcers or ulcer bleeding. No incidence of distant thrombosis has ever been reported. The mechanism of hemostasis induced by thrombin is through the conversion of fibrinogen to fibrin and enhancement of platelets aggregation. This trial aimed to compare the relative efficacy and safety between histoacryl injection and thrombin injection in the prevention of gastric variceal rebleeding.

Conditions

• Ulcer, on Gastric Varices
• Rebleeding From Gastric Varices

Interventions

Type	Name	Description
DRUG	Thrombin	Among the thrombin group, the injection site was also aimed at the bleeding varices or varices with red color signs or at the most prominent varices. The injected agents consisted of lyophilized human Thrombin in calcium chloride solution containing thrombin 500IU/ml). (Floseal, Baxter Healthcare Corporation, CA, Hayward, USA)
DRUG	Histoacryl	The injection site was aimed at the bleeding varices or varices with red color signs or at the most prominent varices.

Timeline

• Start date: 2012-10-01
• Primary completion: 2016-04-01
• First posted: 2012-10-30
• Last updated: 2012-11-06

Locations

1 site across 1 country: Taiwan