What is Evarrest and what is it used for?
Evarrest is a product used in adults during surgery to stop bleeding, whereas the standard methods for controlling bleeding are insufficient. It consists of absorbable material coated on one side with two active ingredients ( fibrinogen and thrombin ) and is available as a 10.2 cm x 10.2 cm sealing matrix. During the procedure, the matrices are cut according to the size and shape needed to seal the bleeding area.
How is Evarrest used?
Evarrest should only be used by experienced surgeons, who will evaluate the amount to be used based on the size and location of the bleeding area. Only a single layer should be applied, overlapping it by 1-2 cm on the surrounding non-bleeding tissue. Evarrest is made up of absorbable material that does not need to be removed after surgery. The material is absorbed by the body over approximately 8 weeks. However, no more than two units should be left behind, because with larger quantities, not enough experience was collected.
How does Evarrest work?
The active ingredients of Evarrest, fibrinogen and thrombin, are proteins extracted from the blood, implicated in the natural coagulation process. Thrombin works by dividing fibrinogen into smaller units called fibrins, which subsequently aggregate to form clots. When an Evarrest matrix is applied to a bleeding area during surgery, moisture triggers the reaction between the two active ingredients, resulting in the rapid formation of clots. The clots allow the matrix to adhere more firmly to the tissue, helping to stop the bleeding.
What benefit has Evarrest shown during the studies?
Studies have shown that Evarrest is effective in helping to stop bleeding during surgery: in most patients the bleeding stopped within 4 minutes. One study compared Evarrest with another product, Surgicel, in patients undergoing abdominal, thoracic and pelvic surgery. In 98% (59 out of 60) of patients in the group treated with Evarrest the bleeding stopped within 4 minutes (without reappearance of bleeding during a 6-minute observation period); this result was observed in 53% of the subjects treated with Surgicel (16 out of 30). Two studies compared Evarrest with commonly used surgical techniques considered standard. In a study of patients undergoing abdominal, thoracic and pelvic surgery, the bleeding stopped within 4 minutes in 84% (50 of 59) of patients treated with Evarrest, compared to 31% (10 of 32) of patients treated with the standard technique. Similar results emerged from a study of patients undergoing liver surgery: the bleeding stopped within 4 minutes in 83% (33 of 40) of patients treated with Evarrest, compared to 30% (13 of 44) of patients treated with the standard technique.
What is the risk associated with Evarrest?
Complications seen in patients treated with Evarrest are generally related to the surgical procedure and previous conditions, and include postoperative bleeding and increased levels of fibrinogen in the blood. For the full list of all side effects reported with Evarrest, see the package leaflet. Evarrest must not be used to repair lesions of the walls of large blood vessels, it must not be applied inside the blood vessels and must not be used in enclosed spaces (for example, openings in the bones). Furthermore, it must not be used in the presence of an active infection or in contaminated parts.
Why has Evarrest been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) has found that Evarrest has been shown to be effective in stopping bleeding during surgery and could be an appropriate alternative to other products and techniques. Complications observed in the studies conducted with Evarrest were generally due to the surgical procedure and previous conditions, although cases of recurrence of bleeding were observed from the sites where Evarrest matrices had been used. Evarrest should therefore only be used when the standard methods for bleeding control are insufficient.
The CHMP concluded that Evarrest's benefits are greater than its risks and recommended that it be given marketing authorization.
What information is still awaited for Evarrest?
A risk management plan has been developed to ensure that Evarrest is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the information sheet of Evarrest, including the appropriate precautions to be followed by healthcare professionals and patients.
More information on Evarrest
On 25 September 2013, the European Commission issued a marketing authorization for Evarrest, valid throughout the European Union. The full EPAR for Evarrest can be found on the Agency's website: ema.Europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about treatment with Evarrest, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 09-2013
