Blood LossNCT02429713
The Effects of Tourniquet Use in Total Knee Arthroplasty
A study testing Short-duration tourniquet and Long-duration tourniquet in people with Blood Loss, run by Peking University People's Hospital.
Trial summary
Tourniquets are still widely used in total knee arthroplasty, but are associated with several adverse effects. Most of previous studies did not randomize the participants so the baseline difference of the patients might have influenced the outcome. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Blood Loss
- What is being tested?
- Short-duration tourniquet and Long-duration tourniquet
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients aged 50 years or over
- classified as American Society of Anesthesiologists ASA 1-2.
Who cannot join
- coagulopathy,
- uncontrolled hypertension,
- peripheral vascular disease and
- patients with BMI≥35
About this study
Official title: The Effects of Tourniquet Use in Total Knee Arthroplasty: A Randomized Controlled Trial
Tourniquets are still widely used in total knee arthroplasty, but are associated with several adverse effects. Most of previous studies did not randomize the participants so the baseline difference of the patients might have influenced the outcome. Therefore, investigators conducted a randomized controlled trial, in which all the patients received staged bilateral TKA with two different durations of tourniquet use. Investigators aimed to quantify the effect of tourniquet use on reducing blood loss and to evaluate the impact of tourniquet use on functional and clinical outcome.
Read the detailed description
Fifty participants who underwent staged bilateral TKA were recruited in this study. On one side, the tourniquet was inflated immediately before incision and deflated after the hardening of the cement. On the other side the tourniquet was inflated immediately before cement application and deflated after its hardening. Blood loss, operating time, transfusion rate, postoperative pain, limb swelling, deep vein thrombosis (DVT) incidence and clinical outcomes were monitored for comparison.
- Conditions
- Blood Loss
- Being tested
- Short-duration tourniquet, Long-duration tourniquet
- Keywords
- tourniquet, total knee arthroplasty, blood loss
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short-duration tourniquetProcedure or surgery
Short-duration tourniquet group:inflate the tourniquet immediately before cement application and deflated after its hardening
Long-duration tourniquetProcedure or surgery
Long-duration tourniquet group: inflate the tourniquet immediately before incision and deflated after the hardening of the cement
| Study group | Role | What they receive |
|---|---|---|
| Short-duration tourniquet group | Experimental | The tourniquet was inflated immediately before cement application and deflated after its hardening Receives: Procedure: Short-duration tourniquet |
| Long-duration tourniquet group | Active comparator | The tourniquet was inflated immediately before incision and deflated after the hardening of the cement Receives: Procedure: Long-duration tourniquet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative blood loss
Measured: within operation
Secondary outcomes (3)
Thigh pain measured by Visual Analogue Scale/Score (VAS)
Measured: 1 day, 2 day, 1 week, 2 week and 6 week after surgery
Thigh swelling measured by circumference 10 cm proximal to the patella
Measured: 1 day, 2 day, 1week, 2 week and 6 week after surgery
Postoperative blood loss measured by drainage volume
Measured: 1 day and 2 day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2015 (estimated)
- Study startJan 2014
- Primary completionFeb 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Blood LossStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Kai, Peking University People's Hospital
- Investigators
- Jianhao Lin, M.D., Study director, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02429713
- Sponsor's protocol ID
- PekingUPH
- Status last verified
- Apr 2015
- First submitted
- 15 Apr 2015
- Last updated
- 29 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Tai TW, Lin CJ, Jou IM, Chang CW, Lai KA, Yang CY. Tourniquet use in total knee arthroplasty: a meta-analysis. Knee Surg Sports Traumatol Arthrosc. 2011 Jul;19(7):1121-30. doi: 10.1007/s00167-010-1342-7. Epub 2010 Dec 15.
PubMed 21161177Hernandez AJ, Almeida AM, Favaro E, Sguizzato GT. The influence of tourniquet use and operative time on the incidence of deep vein thrombosis in total knee arthroplasty. Clinics (Sao Paulo). 2012 Sep;67(9):1053-7. doi: 10.6061/clinics/2012(09)12.
PubMed 23018303
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Tourniquet Use in Total Knee Arthroplasty: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02429713
- Acronym / sponsor ID
- PekingUPH
- Conditions
- Blood Loss
- Keywords
- tourniquet, total knee arthroplasty, blood loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 29 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Tourniquets are still widely used in total knee arthroplasty, but are associated with several adverse effects. Most of previous studies did not randomize the participants so the baseline difference of the patients might have influenced the outcome. Therefore, investigators conducted a randomized controlled trial, in which all the patients received staged bilateral TKA with two different durations of tourniquet use. Investigators aimed to quantify the effect of tourniquet use on reducing blood loss and to evaluate the impact of tourniquet use on functional and clinical outcome.
Detailed description
Fifty participants who underwent staged bilateral TKA were recruited in this study. On one side, the tourniquet was inflated immediately before incision and deflated after the hardening of the cement. On the other side the tourniquet was inflated immediately before cement application and deflated after its hardening. Blood loss, operating time, transfusion rate, postoperative pain, limb swelling, deep vein thrombosis (DVT) incidence and clinical outcomes were monitored for comparison.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short-duration tourniquet group | Experimental | Procedure: Short-duration tourniquetThe tourniquet was inflated immediately before cement application and deflated after its hardening |
| Long-duration tourniquet group | Active comparator | Procedure: Long-duration tourniquetThe tourniquet was inflated immediately before incision and deflated after the hardening of the cement |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients aged 50 years or over
- classified as American Society of Anesthesiologists ASA 1-2.
Key exclusion criteria (4 listed)
- coagulopathy,
- uncontrolled hypertension,
- peripheral vascular disease and
- patients with BMI≥35
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Short-duration tourniquetShort-duration tourniquet group:inflate the tourniquet immediately before cement application and deflated after its hardening | Procedure or surgery | Short-duration tourniquet group |
| Long-duration tourniquetLong-duration tourniquet group: inflate the tourniquet immediately before incision and deflated after the hardening of the cement | Procedure or surgery | Long-duration tourniquet group |
Primary outcome
Intraoperative blood loss
Time frame: within operation
3 secondary outcomes
Thigh pain measured by Visual Analogue Scale/Score (VAS)
Time frame: 1 day, 2 day, 1 week, 2 week and 6 week after surgery
Thigh swelling measured by circumference 10 cm proximal to the patella
Time frame: 1 day, 2 day, 1week, 2 week and 6 week after surgery
Postoperative blood loss measured by drainage volume
Time frame: 1 day and 2 day after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2015.
- Background: PubMed 21161177Tai TW, Lin CJ, Jou IM, Chang CW, Lai KA, Yang CY. Tourniquet use in total knee arthroplasty: a meta-analysis. Knee Surg Sports Traumatol Arthrosc. 2011 Jul;19(7):1121-30. doi: 10.1007/s00167-010-1342-7. Epub 2010 Dec 15.
- Background: PubMed 23018303Hernandez AJ, Almeida AM, Favaro E, Sguizzato GT. The influence of tourniquet use and operative time on the incidence of deep vein thrombosis in total knee arthroplasty. Clinics (Sao Paulo). 2012 Sep;67(9):1053-7. doi: 10.6061/clinics/2012(09)12.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianhao Lin, M.D. study director
Peking University People's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Short-duration tourniquet and Long-duration tourniquet in people with Blood Loss, run by Peking University People's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative blood loss (time frame: within operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02429713, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2015.