Clinical Evaluation of Hemospray in Hemostasis of Active Variceal Bleeding
The objective of this study is to assess the effectiveness of Hemospray in achieving initial hemostasis and decreased rate of re-bleeding in patients of acute variceal bleeding.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Clinical Evaluation of Hemospray in Hemostasis of Active Variceal Bleeding|
- Safety [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]Safety will be characterized by the incidence of all Adverse Device Effects (ADEs), non-serious and serious, possibly related to or related to the procedure and/or device that are experienced by study participants.
- Effectiveness [ Time Frame: 24 hours ] [ Designated as safety issue: No ]Information on efficacy will be obtained by measurements the proportion of patients with acute (procedural) hemostasis, and the rate of recurrent bleeding within 72 hours of treatment.
|Study Start Date:||January 2013|
|Study Completion Date:||June 2014|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Experimental: Hemospray Group
Hemospray device consists of a syringe containing the Hemospray powder (21 g per syringe), a delivery catheter that will be inserted into the working channel of the endoscope, and an introducer handle with a built-in carbon dioxide canister to propel the Hemospray powder out of the catheter.
In addition to Hemospray device any other required endoscopic accessories can be used during the procedure.
Patients will be resuscitated as needed to achieve hemodynamic stability in preparation for endoscopy within 24 hours of hospital admission.
once the bleeding point will be identified at endoscopy, the delivery catheter will be inserted through the endoscope and positioned toward the lesion, leaving 1-2 cm between the bleeding site and the catheter tip.
Hemospray will be then delivered in short spray bursts (for 1-2 seconds) until hemostasis was confirmed.
Once bleeding was controlled , the bleeding site will be observed for 5 minutes under endoscopy.
Oral food and fluid will be with held from the patient for 24 hours. Intravenous octreotide and esomeprazole will given for up to 24 hours. Patients will be closely monitored for signs of recurrent bleeding for 24 hours post procedure.
Recurrent bleeding will be diagnosed any patient experiencing recurrent bleeding will treated according to the institutional standard of care
Please refer to this study by its ClinicalTrials.gov identifier: NCT01783899
|Erasme Hospital , ULB|
|Brussels, Belgium, 1070|
|Theodor Bilharz Research Institute|
|Giza, Egypt, 12311|
|Principal Investigator:||Mostafa Ibrahim, MD||Université Libre de Bruxelles|