Effects of External Leg Compression Devices on Healing and Blood Clotting
Study Details
Study Description
Brief Summary
This study aims to compare two different external calf compression devices applied in healthy individuals. These devices are commonly used in medical care in order to prevent the formation of blood clots, for example during immobilization after surgery. We aim to confirm the effects of external cyclic compression on healing and blood clotting and also to identify the one which is more effective.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Aims:
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To confirm that IPC (intermittent pneumatic compression) has a positive effect on systemic coagulation status, tissue metabolic activity, collagen formation and tissue microcirculation.
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To compare the above effect of two different IPC devices: one rapid calf-IPC which expels blood from the veins sharp and rapidly and one slow calf-IPC, which pumps the blood in a more gentle and progressive way. This study could also make implications on how the blood flow parameters could be interpreted in the clinical setting, as previous haemodynamic studies have explained the superiority of the rapid device in terms of peak velocity and the superiority of the slow device in terms of total ejected volume per individual stimulus.
Materials and Methods: 10-15 healthy individuals are planned to be recruited. The subjects will be lying in a prone position. A cuff connected with a Calf-IPC device will be wrapped around each calf and will be functioning for 120 minutes. Microdialysis catheters will be inserted with the tips about 1 mm from the volar side of each Achilles tendon. In addition, one adhesive sensor will be applied on each calf just distal to the lower part of the cuff, in order to measure tissue oxygen mixed saturation (INVOS). Blood samples will be taken via a venous catheter in antecubital fossa just before the application of the IPC, and at 30, 60 and 120 minutes. From the serum, several systemic coagulation factors will be measured (tissue plasminogen activator (tPA), plasminogen activator inhibitor type 1 (PAI), tissue factor pathway inhibitor (TFPI), D-dimer, von Willebrand factor and factor VIIa). From the microdialysis diffusate , two groups of substances will be measured: a) metabolites, such as pyruvate and b) collagen macromolecules, such as procollagen type I and III.
The ultimate goal is to assess the role of different IPC patterns on deep venous thrombosis prevention and promotion of tissue healing.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Rapid calf-IPC Cyclic external compression in both calves through a cuff connected to VenaFlow® Elite System, DJO, CA, USA |
Device: Intermittent Pneumatic Compression, Rapid
Cyclic external compression in both calves through a cuff connected to a device which pumps venous blood in a sharp and rapid way
|
| Active Comparator: subjects under slow calf-IPC Cyclic external compression in both calves through a cuff connected to Kendall SCD™ 700, Covidien, Medtronic, USA |
Device: Intermittent Pneumatic Compression, Slow
Cyclic external compression in both calves through a cuff connected to a device which pumps venous blood in a smooth, slow and progressive way
|
Outcome Measures
Primary Outcome Measures
- systemic coagulation status [2 hours]
serum levels of coagulation factors (vWF, tPA, PAI-1, Factor VIIa, TFPI, D-dimer)
Secondary Outcome Measures
- local metabolic activity [2 hours]
Measurement of tissue metabolic products (eg pyruvate) from diffusate extracted with microdialysis in the Achilles paratenon.
- collagen production [2 hours]
Measurement of collagen from diffusate obtained with microdialysis in the Achilles paratenon.
- regional microcirculation [2.5 hours]
Mixed oxygen tissue saturation is continuously measured in the lower leg with infrared spectroscopy
Eligibility Criteria
Criteria
Inclusion Criteria:
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Healthy individuals
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Male gender
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Age 18-60
Exclusion Criteria:
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Smoking
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Severe cardiovascular or renal disease causing pitting oedema
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Previous operation in the lower limbs affecting the vascular or lymphatic system
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Karolinska university Hospital | Stockholm | Sweden | 17176 |
Sponsors and Collaborators
- Karolinska University Hospital
Investigators
- Principal Investigator: Paul Ackermann, Karolinska University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SW2017-01-COAGMET