Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized Control Study to Determine the Efficacy and Safety of Combining Hemospray With Medical Standard of Care Treatment in the Management of Acute Variceal Bleeding in Cirrhotic Patients.
Brief Summary: 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).


Options:
A: Arm Label: Hemospray; Type: EXPERIMENTAL; Interventions: Device: Hemospray, Drug: Octreotide, Biological: Blood transfusion, Drug: Ceftriaxone | Arm Label: Non Hemospray; Type: ACTIVE_COMPARATOR; Interventions: Drug: Octreotide, Biological: Blood transfusion, Drug: Ceftriaxone | Intervention Type: DEVICE; Name: Hemospray; Assigned to Arm(s): Hemospray | Intervention Type: DRUG; Name: Octreotide; Assigned to Arm(s): Hemospray, Non Hemospray | Intervention Type: BIOLOGICAL; Name: Blood transfusion; Assigned to Arm(s): Hemospray, Non Hemospray | Intervention Type: DRUG; Name: Ceftriaxone; Assigned to Arm(s): Hemospray, Non Hemospray
B: Arm Label: Sclerotherapy group; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Sclerotherapy | Arm Label: Endoscopic band ligation group; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Band ligation | Arm Label: Sclero-ligation (SL) group; Type: EXPERIMENTAL; Interventions: Procedure: Scleroligation | Intervention Type: PROCEDURE; Name: Sclerotherapy; Assigned to Arm(s): Sclerotherapy group | Intervention Type: PROCEDURE; Name: Band ligation; Assigned to Arm(s): Endoscopic band ligation group | Intervention Type: PROCEDURE; Name: Scleroligation; Assigned to Arm(s): Sclero-ligation (SL) group
C: Arm Label: Portacaval shunt; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Portacaval shunt | Arm Label: Sclerotherapy; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Sclerotherapy | Intervention Type: PROCEDURE; Name: Portacaval shunt; Assigned to Arm(s): Portacaval shunt | Intervention Type: PROCEDURE; Name: Sclerotherapy; Assigned to Arm(s): Sclerotherapy
D: Arm Label: Self-expandable esophageal stent; Type: ACTIVE_COMPARATOR; Interventions: Device: Stent | Arm Label: Sengstaken-Blakemore tube; Type: ACTIVE_COMPARATOR; Interventions: Device: Tamponade | Intervention Type: DEVICE; Name: Stent; Assigned to Arm(s): Self-expandable esophageal stent | Intervention Type: DEVICE; Name: Tamponade; Assigned to Arm(s): Sengstaken-Blakemore tube

Answer: A