Please select the eligibility criteria that correspond 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: 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
B: Inclusion Criteria:

* cirrhotic patients presenting with an acute or recent episode of gastro-esophageal variceal bleeding.

Exclusion Criteria:

* Patients were excluded if they had malignancy of any origin.
* Any terminal illness, such as heart failure, uremia, or chronic pulmonary diseases.
* Other potential causes of GIT bleeding.
* Patients with previous endoscopic or surgical intervention for varices were also excluded.
C: Inclusion Criteria:

* All patients with upper gastrointestinal bleeding (blood in the upper gastrointestinal tract) of a magnitude that required 2 or more units of blood transfusion and entered the emergency room directly, or were referred from an area hospital, or developed bleeding while in the hospital, and were shown to have cirrhosis of the liver, and were shown by endoscopy to have bleeding gastric varices, absence of bleeding from esophageal varices, and absence of any other lesion that could reasonably account for the bleeding were included ("all comers").

Exclusion Criteria:

* None
D: Inclusion Criteria:

The study will include all patients with cirrhosis admitted to the hospital because an acute esophageal variceal bleeding defined according to Baveno II criteria (5) and who will achieve the following criteria:

* Failure to control bleeding despite pharmacological (somatostatin 3 or 6 mg/12h iv or terlipressin, 2mg/4h iv) AND endoscopic therapy (esophageal banding ligation preferably or sclerotherapy). Failure to control bleeding was defined, according to Baveno IV criteria (6), as evidence of continuous digestive bleeding and any of the following:

  * Hematemesis (or naso-gastric aspirate \> 100 ml of fresh blood) \> 2h after the start of combined pharmacological and endoscopic therapy.
  * Decrease in hemoglobin values \> 3g vs previous values (without blood transfusion).
* Massive bleeding. Acute variceal bleeding uncontrolled despite pharmacological therapy started at any moment, with no need of previous endoscopic therapy. Uncontrolled bleeding is defined as an upper digestive bleeding in which no hemodynamic stability (systolic arterial pressure \> 70 mmHg and heart rate \< 100 bpm) could be achieved.

Exclusion Criteria:

* Age \< 18 years.
* Esophageal rupture.
* Esophageal, gastric or upper respiratory tract tumor.
* Esophageal stenosis.
* Recent esophageal surgery.
* Previous esophageal tamponade to treat the index bleed.
* Big hiatal hernia precluding the correct placement of the esophageal devices.
* Known hepatocellular carcinoma surpassing Milan criteria.
* Terminal disease.
* No written consent to participate in the study.

Answer: A