Haemostatic agents (Floseal, Surgiflo)

Tagged bleeding, haemostatic agents; Comments 3 ; Posted 12 years ago

I have been asked to describe in what areas patients benefit from haemostatic agents. Haemostatic agents include Floseal, Surgiflo, Tisseel, Surgicel, Fibrillar or Surgicel Snow, only to name the most common Australian brand names.

Clearly these agents are extremely useful surgical aides and may have a massive impact on surgical outcomes. This article will describe what these products are, and what the evidence for their usage is.

[On the image you can see Surgiflo applied to the vaginal vault and to both obturator fossa]

To start with, we can classify haemostatic agents in those who consist just of a mechanical matrix (they act as mechanical tamponade), or those who have a biological substance built into the matrix.

Matrix: Surgicel consists simply of cellulose and is marketed since the 1940ies. Oxidation will convert the hydroxyl groups into carboxylic acid, which allows for denaturation of blood proteins initiating haemostasis. Fibrillar and SNoW are more modern variants of Surgicel, have a faster time to haemostasis and also act bacteriostatic.

A relatively new matrix is Gelatin. Surgiflo marketed through Ethicon is a substance that consists simply of Gelatin. We use it in laparoscopic surgery to control oozing and prevent bleeding.  Once put on flesh it will swell, thus giving a tamponade effect. Surgiflo can be quickly and easily be prepared in the operating room. The haemostatic effect of Surgiflo is purely mechanical. In the US, Surgiflo is available in a kit together with Thrombin.  

These products are used since the 1940ies when regulations were relaxed and the need to stop bleeding during the war was greater than to regulate the government approval of surgical devices. Hence, these devices never had to prove that they actually do what they promise to do. For example: Stop bleeding. On Surgiflo there are a total of 7 papers in the world literature. Four of them are on animal models. There si no randomised trial on how well Surgiflo works.

The second large group are biologically active substances, such as Thrombin or Fibrin.

The third group are combination agents that deliver a biological agent through a matrix. This is the most interesting group for us surgeons because they are quite powerful haemostatic agents.  

Floseal (Baxter) is a substance that will be prepared in the operating room. It consists of a Gelatin matrix plus Thrombin. It can be used in Jehovah’s Witness patients and stops bleeding in more than 90% of all patients within 2 minutes. The issue that I see with Floseal is its relatively complex assembly procedure. The only downside to this product is its assembly: As a surgeon you really need a scout nurse who is skilled to mix the stuff together. You just can’t do it alone.  

Where do I see the value of these products for patients?

First, I would not bet my house that matrix haemostatic agent would get me out of trouble if I were in trouble. There are plenty of efficacy data on Floseal (stops bleeding within 2 minutes in more than 90% of patients) but none for Surgiflo or for any of the other matrix haemostatic agents.

However, if you are used to Surgiflo you could also use Surgiflo and instead of mixing it with 2 ml of water, you can mix it with 2 ml of Thrombin. It’s got to work. However, I personally have not done this before.

I see 4 clinical areas where haemostatic agents can make an impact on patients’ surgery:

1. The rate of conversion from laparoscopic to open could decrease. A number of laparoscopic procedures will get converted because of bleeding issues. A powerful haemostatic agent will assist the surgeon to carry on laparoscopically.
2. When I trained, bleeding from the presacral areas was of major concern and I heard that patients who who were treated some 50 years ago even died of presacral bleeding. With those new haemostatic agents, this is preventable.
3. In the past, surgeons may have need to resort to abdominal or pelvic packing to secure haemostasis. One of the down sides of the procedure was that the operation had to be abandoned. The patient had to be transferred to the intensive care unit and kept intubated until she could be returned to the operating theatre to remove the packs. Haemostatic agents will allow us to stop surgical bleeding and complete the procedure.
4. Sometimes, the spleen can get torn during surgery. Typically, sutures don’t work for haemostasis and in the past we had to remove the spleen, which can lead to complications may years down the track. With haemostatic agents, I was able to preserve a number of spleens and save the patient from taking antibiotics life long.

However, the evidence on haemostatic agents and ist clinical use (for example to prevent bleeding) need to become a lot better. Until now these agents are sold based on the obviousness of these devices.

However, side effects from those devices have been observed. Especially in hysterectomy, where bacteria can ascend from the vagina into the pelvis, infections can easily occur. I want to make sure that the device that I use in my patients doesn’t harm them. While I am convinced that the data in clean surgery is safe (myometctomy, excision of endometriosis, pelvic floor repair), I am not convinced that the use of haemostatic agents in “clean-contaminated” surgery (hysterectomy) is safe as yet.

For “clean-contaminated” surgery, we need to collect data first before we apply them outside any research setting. SurgicalPerformance currently evaluates Surgiflo, its safety and efficacy in the setting of hysterectomy - participation is free for medical practitioners. Registere here. 

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