To investigate the effect of tourniquet application on the coagulation system in patients undergoing a knee arthroscopy. A finding of more prominent activation of the coagulation system with tourniquet use than with non-use will create an important…
ID
Source
Brief title
Condition
- Joint disorders
- Embolism and thrombosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Data on duration of surgery and duration of tourniquet use will be collected.
Blood collected from the cubital vein and the great saphenous vein during
arthroscopy of the knee will be analyzed on outcome parameters that reflect a
hypoxic state, an inflammatory reaction, involvement of the endothelium, a
procoagulant state and thrombin formation.
Primary markers:
• Prothrombin fragments 1 + 2
• von Willebrand Factor (vWF)
• D-dimer
• P-selectin
• Plasmin Activator Inhibitor 1 (PAI-1)
• pH
• pO2
• pCO2
• Lactate
• White Blood Cell Count (WBCC)
Secondary outcome
• factor VIII
• Thrombin and Antithrombin complexes (TAT)
• Plasmin and antiplasmin complexes (PAP)
• E-selectin
• Tissue plasminogen activator (tPA)
• Thrombomodulin
• Neutrophil extracellular traps (NETs)
Background summary
Knee arthroscopy is the most commonly performed orthopaedic procedure
worldwide, with, according to the American Society for Sports Medicine, over 4
million procedures performed each year. The risk of venous thrombosis following
this procedure is considerable with rates of symptomatic events varying between
0.9% and 4.6%.
It is currently unknown how this high risk comes about considering its short
duration and minimal tissue damage caused by the procedure. A factor that may
play a role is the use of a tourniquet. A large majority of orthopaedic
surgeons prefer to operate within a *dry field*, which is obtained by the use
of a tourniquet. In the proposed study we will investigate the effect of a
tourniquet on local and systemic markers of hypoxia, inflammation, involvement
of endothelium, and coagulation activation.
Study objective
To investigate the effect of tourniquet application on the coagulation system
in patients undergoing a knee arthroscopy. A finding of more prominent
activation of the coagulation system with tourniquet use than with non-use will
create an important opportunity to prevent thromboembolic events in these
patients, as it has been shown that knee arthroscopy can be performed
adequately without the use of a tourniquet. Furthermore, it will increase our
understanding of the pathophysiology of thrombosis.
Study design
In a randomized, controlled clinical study we will compare local and systemic
coagulation and inflammation markers before and after knee arthroscopy between
two groups: 25 patients will be randomized to arthroscopy with tourniquet
(Group I) and 25 patients to arthroscopy without tourniquet (Group II).
Intervention
Patients will be randomized to knee arthroscopy without tourniquet use and to
knee arthroscopy with tourniquet use. In patients randomized to arthroscopy
with tourniquet use, exsanguination in the leg in which the knee arthroscopy
will be performed will be accomplished by raising the leg vertically for one
minute. The tourniquet will be inflated to 100-150 mmHg above systolic blood
pressure.
Study burden and risks
We will compare two surgical regiments that are currently both used depending
on the physician*s or hospital*s preference. The patients in our trial will be
subjected to one of these standard treatments. It is therefore not expected
that participation will lead to an increased health risk. All patients will
need to receive one additional intravenous catheter for blood sampling for the
study in the great saphenous vein, next to the intravenous catheter in the arm,
which is already in place because of the surgery. This intravenous catheter
will be placed after patients have received spinal anaesthesia, to minimize the
burden. Blood samples will be taken pre and post-operatively on three
different time points. With the use of an intravenous catheter, patients do not
require numerous vena punctures. No extra hospital visits are required for the
study.
Bleulandweg 10
Gouda 2803 HH
NL
Bleulandweg 10
Gouda 2803 HH
NL
Listed location countries
Age
Inclusion criteria
Age of 18 years or older and arthroscopy of the knee for the following indications: Meniscectomy, diagnostic arthroscopy, removal of corpora libera
Exclusion criteria
• Any kind of coagulation disorder
• pregnant or within 3 months of childbirth
• Use of hormonal anticonception
• A history of venous thrombosis
• Had major surgery in the past two monhts
• A history of cast-immobilization of the lower extremity the past two months
• A neoplasm or inflammatory disease
• A BMI>30
• using anticoagulant therapy
• Any other anaesthesia technique than spinal anaesthesia
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| CCMO | NL49117.058.14 |