FAQ study participants - STOP Leg Clots

Questions at start of study

1. When and where did the study start?

The study was started 2018-05-01 at the Karolinska University hospital in Stockholm and is in successive expansion to include various other hospitals in Sweden and internationally.

2. Will you receive any financial compensation for participating in the study?

No, however, as a study participant you are likely to benefit from the closer contact with healthcare professionals during your treatment-period. In addition, during the study it will be controlled if you have a blood clot when you take off your plaster cast/orthosis, which normally would not be done if you did not participate in the study.

3. Which limb immobilization alternative gives the least risk of getting a blood clot in the lower leg?

At present, it is not determined which immobilization alternative that gives the least risk of having a blood clot in the lower leg. This is what will be investigated in this study.

4. How is a blood clot treated?

If a blood clot is found it may be treated either with pills or injections, usually for at least 3 months. Many hospitals also have as a routine to investigate if there is any other underlying disease that caused the blood clot to be formed.

5. Why didn't I get blood thinning medicine?

There is no strong scientific evidence that blood thinning medicine effectively reduce the risk of blood clots formation during lower leg immobilization after ankle fractures or Achilles tendon ruptures. In addition, there are negative side effects to blood thinning medication such as increased risk of bleeding. Thus, blood thinning medication is, according to international guidelines, not advised as a general preventative treatment during leg immobilization. However, if you have certain risk factors for blood clotting, you should discuss this with your doctor if you may receive blood thinning medicine in addition to the study treatment.

6. If I join the study and want to be treated with IPC - can this be arranged?

No. The IPC-treatment will be randomly assigned to half of the study participants and this can neither be influenced by the patients nor the study staff.

Treatment

1. My injured lower leg has been immobilized. How long after surgery should my injured lower leg be immobilized?

The time for immobilization differs depending on the type of injury and on local traditions. In general, the immobilization time is approximately 6 weeks after surgery of ankle fractures or Achilles tendon ruptures.

2. I have pain in my leg after surgery, what should I do?

It is common to experience pain from the operated area for a few days after the surgery. However, once the initial pain following the surgery has receded, you should not experience any new onset of pain in the calf, kneecap or back of the thigh. If you do have a new onset of pain, you must contact your doctor/emergency room.

3. My injured lower leg has been immobilized in a plaster cast/boot orthosis with calf-IPC. Will/can I put load on the injured lower leg?

Your treating physician should decide whether you can or cannot put load on the leg.

Follow-up

1. How do I get in touch with those locally responsible for the study?

Contact information for the persons locally responsible for the study should be present on the paper with information that you received either at the emergency department, or on a separate visit. If this information is not available, you can contact simon.svedman@ki.se who will mediate the contact.

2. Do I have to fill in the diary/diaries both on paper and on the mail?

The diaries in paper format are designed to make it easier for you to remember how much load you put on your leg and for how many hours you used the IPC device. This in turn will make it easier to fill in the electronic forms that you shall send in by e-mail.

3. I have no e-mail address, how do I submit my diaries?

If you bring your diaries for your revisits, the staff at the hospital will ensure that the diaries come to the study staff. If you forget to bring your diaries, please contact those locally responsible.

4. When I can take of my plaster cast/orthosis, am I done with the study then?

After your treatment is completed, we will send you surveys at 6 months after your injury and then again at 12 months after your injury, which you should fill in.

5. I continue to receive requests to fill in my diary this week, even though I have not worn the plaster cast/orthosis during this week. What should I do?

Please, contact those locally responsible for the study.

Pump Treatment

1. The pump alarms when the IPC-device is in use. What should I do?

In some cases, the alarm may be activated because the tubes between the cuffs and the pump have been twisted, or are not properly attached. If the alarm is activated due to any other reason, or the if IPC-device stops working altogether, please contact those locally responsible for the study.

2. The pump clock reset itself without me doing anything! Should I stop using it then?

If the pump automatically resets the timer, it is of the utmost importance that you notice and write down for how many hours and minutes you have been using the IPC-device before the reset and also note the timepoint when the reset happened. After this you can use the IPC-device as usual.

3. The cuffs for the calf that I connect to the IPC-device are/have broken.

Please contact  those locally responsible for the study so they can arrange for you to get new cuffs.

4. If I have got a blood clot, is it dangerous to continue the IPC treatment?

No. IPC treatment is rather associated with a reduced general risk following blood clot formation in the leg.