HemaClear® Frequently Asked Questions

No. HemaClear® is a sterile single-use device that is removed by cutting when the procedure ends. Therefore, it cannot be re-used or re-sterilized.

There are many studies on use or no use of tourniquets in TKA. The frequently used end points are:

Blood loss

Pain

Mobility and strength

The studies all show higher intra-operative blood loss, but no significant overall difference in haemoglobin drop and need for transfusion

Less thigh pain when tourniquet is not used

Better mobility and quad strength when tourniquet is not used.

On the other hand, there is this study from J Arthroplasty that shows deeper cement penetration when tourniquet is used.

Please note that all of these studies were done with pneumatic tourniquets, not HemaClear.

I believe that if a study is done with HC vs. no tourniquet or a three-way study (no tourniquet/Pneumatic tourniquet/HemaClear) there will be advantages found for HemaClear.

As a policy, we do not recommend using HemaClear to surgeons who are not using tourniquets. We do remind them that patients in which they do use a tourniquet (e.g. haemophiliacs, anaemic, Jehovah Witnesses etc.) or in cases where they use a tourniquet “only” during cementation, it is better for the patient to use HemaClear.

Tourniquet Use Improves Cement Penetration and Reduces Radiolucent Line Progression at 5 Years After Total Knee Arthroplasty

• Superior Exsanguination: The rolling action of the occlusive silicone ring pushes 95% of blood out of the limb, as opposed to 67% with the Esmarch bandage, and 45% when a limb elevation method is used.
• Creates a Sterile Field: HemaClear® is a sterile, single use device that eliminates the need for contaminated reusable cuffs, thereby reducing the risk of infection.
• Increases Access to the Surgical Field: Being 1” wide, the narrow profile and small footprint of the HemaClear® facilitates a larger and more accessible surgical field.
• Simple and Cost-Effective: The easy application reduces preparation time and eliminates the need for tourniquet machines, contaminated reusable cuffs, and Esmarch Bandages.
• Reduces Post-Operative Complications: The HemaClear® reduces the risks of post-operative complications such as DVT, Infections, Excessive Blood Loss, Tourniquet Related Pain, Tourniquet Related Skin Lesions (“burns”), and has the potential to reduce Post TKA Cognitive Deficit.
• Used in Over 800,00 Around 1 Million Procedures Worldwide: HemaClear® is FDA listed and CE marked. More than 20 published studies demonstrate the safety, reliability and clinical superiority of HemaClear®
• No Skin Injury (vs. 20.7% for wide cuff)
• Diminished Tourniquet Pain (vs. 39.7% wide cuff)
• No Tourniquet-Induced Nerve Damage (vs. neuropraxia with a pneumatic wide-cuff tourniquet)

• The difference between these models is their tightness, or how much pressure they apply on the limb. The Green Medium and the Blue Large are suitable for the low systolic blood pressure range (up to 130 mm Hg). They are mostly used for pediatric cases. The Red and the Orange are rated to work well when Systolic blood pressure is not greater than 160 mm Hg. They are used for normal adults with no history of high blood pressure. The Yellow and the Brown are for Systolic BP up to 190 mm Hg and we recommend using them when patients may spike high BP during surgery. All models are equally safe and effective.

  BTW, the XL model is used in the upper thigh in almost all adults. Its upper BP pressure is also 160 mm Hg and it is essentially a “one size fits all adults”.

0.5% lidocaine = 0.5 gram in 100 cc = 500 mg. so 20 cc of 0.5% lidocaine = 100 mg = safe dose used often in emergency medicine for cardiac premature beats. This is how much you need for forearm Bier Block. For upper arm Bier Block with pneumatic cuff (no tight stockinet) you need 50-60 cc of 0.5% lidocaine which is 250-300 mg. This is overdose and not safe. May cause seizures and even cardiac arrest. As such, it is customary to wait at least 30-40 minutes after lidocaine injection for upper arm tourniquets before releasing the tourniquet to allow for it to be absorbed into the tissues.

We assume that at least 30 cc of lidocaine is needed for upper arm HemaClear placement (less is needed because the veins are compressed by the HemaClear stockinet). This is 150 mg which is the upper level of safety. If more than this is injected, the 30-40 minutes delay is also needed with HemaClear.

Now what does “slow” pressure release means?

When tourniquet pressure is released slowly, first the tourniquet pressure reaches the systolic level and blood starts to flow INTO the arm. Venous outflow remains zero until the venous pressure increases above the tourniquet pressure. At this point there is a lot of blood in the limb and when the tourniquet pressure is further released a gush of venous blood is exiting the limb into central circulation, not only with lidocaine, but also with Lactate, CO2, H2, K+ etc. Not very good for the heart.

• HemaClear® is a Sterile Exsanguinating Occlusion device for surgical limb procedures – providing up to 95% exsanguination (blood removal) compared to ~67% with current techniques.
• HemaClear® consists of an elastic silicone ring wrapped in a stockinet and 2 pulling straps with handles.
• HemaClear® can be used without a power supply or a compressed air source.