RCT to Determine the Efficacy of Combining Hemospray With Medical Treatment in Acute Variceal Bleeding

Theodor Bilharz Research Institute

Status: Completed

Conditions: Variceal Hemorrhage

Treatments: Drug: Ceftriaxone; Drug: Octreotide; Biological: Blood transfusion; Device: Hemospray

Study type: Interventional

Funder types: Other

Identifiers

NCT03061604

Hemospray Varices RCT

Details and patient eligibility

About

INTRODUCTION Acute variceal bleeding (AVB) is a severe complication of portal hypertension in patients with liver cirrhosis. The primary therapy includes the administration of vasoactive drugs, antibiotics and endoscopic therapy; preferably esophageal banding ligation (EBL) and/or cyanoacrylate injection when bleeding occurs from gastric varices.

In this context, the idea is to assess "Hemospray" (Cook Medical, Winston-Salem, NC) as an initial therapy in patients with massive bleeding as a temporary "bridge" until definitive treatment could be instituted.

The data generated from the pilot study performed between Erasme hospital, ULB and TBRI , Cairo showed that adding Hemospray as early as possible in the management steps could increase the bleeding control rate up to 95 % at 24 hours.

OBJECTIVE The primary efficacy objective of this study is to assess the efficacy of Hemospray in combination with standard of care (SOC) medical treatment compared to the efficacy of SOC in the Control Arm in patient with acute variceal bleeding in cirrhotic patient.

The primary safety objective of this study is to evaluate the safety of Hemospray when used in combination with SOC compared to SOC in the Control Arm.

1.1. Secondary:

• To evaluate the effect of timing of Hemospray treatment on the outcomes of bleeding patients
• To evaluate the adverse effects on both therapeutic regimens (SAEs and clinically significant AEs).

Full description

STUDY ENDPOINTS :

1.1. Primary endpoint: Hemostasis is the primary end point: which is a combined endpoint of Endoscopic hemostasis at (12-24) hours and Clinical hemostasis during (12-24) hours.

1.2. Secondary endpoints:

Need for rescue endoscopy (Before 12h) Safety Interaction with coagulation profile Rebleeding at 5 days. Survival at 5 days Survival at 30 days

Enrollment: 105 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject must be over 18 years of age.
• Suspected or proven acute variceal bleeding , Gastric lavage will be done for all patients at admission (Acute bleeding is confirmed on the presence of blood in stomach)
• Subjects must be willing to give written informed consent for the trial
• Known or suspected cirrhosis

Exclusion criteria

• Patient is: < 18 years of age
• Unable to consent
• Contraindicated to undergo endoscopy,
• Already hospitalized for another illness
• Pregnant or lactating
• Patients with altered post-surgical anatomy of the stomach
• Previously placed intrahepatic portosystemic shunt
• Patient treated by other endoscopic or surgical modalities within 30 days prior to the intended application of Hemospray

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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105 participants in 2 patient groups

Hemospray

Experimental group

Description:

All subjects will be treated by medical treatment in the terms of combination of vasoactive medication, blood transfusion and Ceftriaxone PLUS Hemospray treatment within 2 hours of admission. The medical treatment will be continued till 12 hours after admission and then second endoscopy will be performed (12-24 hours after admission).

Treatment:

Device: Hemospray

Biological: Blood transfusion

Drug: Octreotide

Drug: Ceftriaxone

Non Hemospray

Active Comparator group

Description:

All subjects will be treated by medical treatment in the terms of combination of Octreotide, blood transfusion and Ceftriaxone. The medical treatment will be continued till 12 hours after admission and then second endoscopy will be performed (12-24 hours after admission).

Treatment:

Biological: Blood transfusion

Drug: Octreotide

Drug: Ceftriaxone