Osteoarthritis, KneeNCT03915756
Postoperative Drainage in Total Knee Arthroplasty in the Presence of Tranexamic Acid
A study testing Drainage of surgical wound in people with Osteoarthritis, Knee, run by Hospital Beatriz Ângelo at 1 site in Portugal.
Trial summary
The investigator's aim with this study is to address, with the new paradigm of tranexamic acid, the role of wound drainage following total knee arthroplasty in blood loss, blood transfusion requirements and functional recovery Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Drainage of surgical wound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 sitePortugal
- Study dates
- 22 Aug 2019to Jul 2022
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Consecutive patients admitted to perform a primary unilateral total knee arthroplasty
Who cannot join
- Contraindication to take tranexamic acid
- hematologic disease with a higher risk of bleeding
- abnormal coagulation tests
- refusal of blood transfusions
- inadequate preoperatory optimization
- deformity >15⁰ of varus or valgus
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
Hospital Beatriz Angelo
Loures, 2674-514
Afonso Cardoso, 00351918972882, afonso.cardoso@hbeatrizangelo.pt
About this study
Official title: Postoperative Drainage in Total Knee Arthroplasty in the Presence of Tranexamic Acid: a Clinical Trial
The investigator's aim with this study is to address, with the new paradigm of tranexamic acid, the role of wound drainage following total knee arthroplasty in blood loss, blood transfusion requirements and functional recovery
Read the detailed description
All participants will attend a preoperatory appointment with an anaesthesiologist where preoperative haemoglobin will be optimized (Hg > 13 g/L).
Randomization will be done by opening a closed envelop with the selected group from a bag at the time of wound closure.
Collected preoperative information will include age, gender, weight, height, body-mass index, underlying diseases, operated side, haematocrit, haemoglobin level, midpatellar knee circumference and range of movement. Blood work was performed within 1 hour of the beginning of the surgery. Clinical parameters will be collected before anaesthesia.
In all cases, the surgeon will perform a medial parapatellar approach with a standard incision with the participants in the supine position. The SIGMA PFC total knee system (DePuy, Warsaw, In) and its posterior-stabilized design with a rotatory platform will be used. All participants will be under a subarachnoid spinal block.
A tourniquet will be used (pressure of 350 mmHg) from the beginning of the surgery and deflated for haemostasis before wound closure. At this time, before complete water-tight fascial closure, the patients will be allocated to group With or Without drain as described, and a drain will be placed in a subfascial position. The drain will be left clamped for 1 hour and will be left in place for 24 hours. Compressive dressings will be applied at the end of the surgery. Continuous passive motion will be started within 24 hours of surgery (0-60°, progressing as tolerated).
In all participants, about 30min before tourniquet release, intravenous tranexamic acid will be used with an initial bolus of 10 mg/kg administered in 10min followed by a perfusion of 10mg/kg over 4h. For postoperative analgesia, a femoral triangle and a popliteal block (anterior approach) will be done in all participants.
A standard fluid therapy of a balanced crystalloid solution (perfusion 10ml/kg/h) will be administered to all patients. After tourniquet release, during haemostasis and in the recovery room, an eventual need of increasing fluid therapy perfusion or a bolus will be noted in the patient's file.
Hidden blood loss will be calculated according to the haemoglobin balance method as it suggested to be the most reliable method. Total blood volume will be calculated as described by Nadler et al.
The normality of the data will be tested with the Shapiro-Wilk test/Kolmogorov-Smirnov test. The data will be compared and analyzed using Student's t-test for independent samples, or the Mann-Whitney test, according to the normality of the data. The correlation of data will be analyzed with the Pearson or Spearman correlation coefficient according to its normality. Nominal variables will be compared using the chi-square test. P-values less than 0.05 will be considered significant. Dedicated statistical software (SPSS version 21, SPSS Inc., Chicago, USA) will be used.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Drainage of surgical wound
- Keywords
- Knee replacement, Blood loss, Wound drainage
- Medical subject headings
- Osteoarthritis, Knee, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drainage of surgical woundProcedure or surgery
Introduction of a drain before full fascial closure
| Study group | Role | What they receive |
|---|---|---|
| With drain | Experimental | Participants who received a drain during surgery Receives: Procedure: Drainage of surgical wound |
| Without drain | No intervention | Participants who did not receive a drain during surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total RBC loss
Total red blood cells loss after surgery
Measured: 96 hours
Total RBC loss
Total red blood cells loss after surgery
Measured: 24 hours
Total RBC loss
Total red blood cells loss after surgery
Measured: 1 hour
Blood transfusion requirements
Blood transfusions requirements
Measured: 96 hours
Knee Society Score score
Knee Society Score measuring function of Knee (0-100 total score, higher values, better outcome)
Measured: 14 days
Secondary outcomes (22)
Haematocrit level
Haematocrit level
Measured: 1 hour
Haematocrit level
Haematocrit level
Measured: 24 hours
Haematocrit level
Haematocrit level
Measured: 96 hours
Haemoglobin level
Haemoglobin level
Measured: 1 hour
Haemoglobin level
Haemoglobin level
Measured: 24 hours
Haemoglobin level
Haemoglobin level
Measured: 96 hours
Surgery duration
Surgery duration (min)
Measured: 0hour
Length of skin incision
Length of skin incision
Measured: 0 hour
Tourniquet duration
Tourniquet duration (min)
Measured: 0 hour
Surgical blood loss
Surgical blood loss (mL)
Measured: 0 hour
Iron
Iron products used
Measured: 96 hours
Transfusion reactions
Transfusion reactions
Measured: 96 hours
Drain volume
Drain volume (mL)
Measured: 24 hours
MKC
Midpatellar Knee Circumference (cm)
Measured: 48 hours
MKC
Midpatellar Knee Circumference (cm)
Measured: 96 hours
MKC
Midpatellar Knee Circumference (cm)
Measured: 14 days
ROM
Range of motion (°)
Measured: 48 hours
ROM
Range of motion (°)
Measured: 96 hours
ROM
Range of motion (°)
Measured: 14 days
Fluidotherapy excess
Fluidotherapy excess (mL)
Measured: 96 hours
Wound complications (i. e., wound dehiscence, infection)
Wound complications (i. e., wound dehiscence, infection)
Measured: 14 days
Lower leg deep vein thrombosis
Lower leg deep vein thrombosis
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start22 Aug 2019
- Primary completionMay 2022 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Beatriz Ângelo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Afonso Cardoso, Hospital Beatriz Ângelo
- Investigators
- Afonso Cardoso, Principal investigator, Hospital Beatriz Angelo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03915756
- Sponsor's protocol ID
- 0389
- Status last verified
- Feb 2021
- First submitted
- 12 Apr 2019
- Last updated
- 15 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cross M, Smith E, Hoy D, Nolte S, Ackerman I, Fransen M, Bridgett L, Williams S, Guillemin F, Hill CL, Laslett LL, Jones G, Cicuttini F, Osborne R, Vos T, Buchbinder R, Woolf A, March L. The global burden of hip and knee osteoarthritis: estimates from the global burden of disease 2010 study. Ann Rheum Dis. 2014 Jul;73(7):1323-30. doi: 10.1136/annrheumdis-2013-204763. Epub 2014 Feb 19.
PubMed 24553908NIH Consensus Panel. NIH Consensus Statement on total knee replacement December 8-10, 2003. J Bone Joint Surg Am. 2004 Jun;86(6):1328-35. doi: 10.2106/00004623-200406000-00031. No abstract available.
PubMed 15173310Banerjee S, Kapadia BH, Issa K, McElroy MJ, Khanuja HS, Harwin SF, Mont MA. Postoperative blood loss prevention in total knee arthroplasty. J Knee Surg. 2013 Dec;26(6):395-400. doi: 10.1055/s-0033-1357491. Epub 2013 Oct 11.
PubMed 24122437Huang GP, Jia XF, Xiang Z, Ji Y, Wu GY, Tang Y, Li J, Zhang J. Tranexamic Acid Reduces Hidden Blood Loss in Patients Undergoing Total Knee Arthroplasty: A Comparative Study and Meta-Analysis. Med Sci Monit. 2016 Mar 10;22:797-802. doi: 10.12659/msm.895571.
PubMed 26961597Wang H, Shen B, Zeng Y. Comparison of topical versus intravenous tranexamic acid in primary total knee arthroplasty: a meta-analysis of randomized controlled and prospective cohort trials. Knee. 2014 Dec;21(6):987-93. doi: 10.1016/j.knee.2014.09.010. Epub 2014 Oct 23.
PubMed 25450009Zhang Y, Zhang JW, Wang BH. Efficacy of tranexamic acid plus drain-clamping to reduce blood loss in total knee arthroplasty: A meta-analysis. Medicine (Baltimore). 2017 Jun;96(26):e7363. doi: 10.1097/MD.0000000000007363.
PubMed 28658157Liao L, Chen Y, Tang Q, Chen YY, Wang WC. Tranexamic acid plus drain-clamping can reduce blood loss in total knee arthroplasty: A systematic review and meta-analysis. Int J Surg. 2018 Apr;52:334-341. doi: 10.1016/j.ijsu.2018.01.040. Epub 2018 Feb 3.
PubMed 29408472Craik JD, Ei Shafie SA, Kidd AG, Twyman RS. Can local administration of tranexamic acid during total knee arthroplasty reduce blood loss and transfusion requirements in the absence of surgical drains? Eur J Orthop Surg Traumatol. 2014 Apr;24(3):379-84. doi: 10.1007/s00590-013-1206-1. Epub 2013 Mar 14.
PubMed 23494778Yang Y, Lv YM, Ding PJ, Li J, Ying-Ze Z. The reduction in blood loss with intra-articular injection of tranexamic acid in unilateral total knee arthroplasty without operative drains: a randomized controlled trial. Eur J Orthop Surg Traumatol. 2015 Jan;25(1):135-9. doi: 10.1007/s00590-014-1461-9. Epub 2014 May 10.
PubMed 24816760Gao FQ, Li ZJ, Zhang K, Sun W, Zhang H. Four Methods for Calculating Blood-loss after Total Knee Arthroplasty. Chin Med J (Engl). 2015 Nov 5;128(21):2856-60. doi: 10.4103/0366-6999.168041.
PubMed 26521781Nadler SB, Hidalgo JH, Bloch T. Prediction of blood volume in normal human adults. Surgery. 1962 Feb;51(2):224-32. No abstract available.
PubMed 21936146
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Drainage in Total Knee Arthroplasty in the Presence of Tranexamic Acid: a Clinical Trial
- ClinicalTrials.gov ID
- NCT03915756
- Acronym / sponsor ID
- 0389
- Conditions
- Osteoarthritis, Knee
- Keywords
- Knee replacement, Blood loss, Wound drainage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Hospital Beatriz ÂngeloUniversity, hospital or other
- Study start
- 22 Aug 2019 (actual)
- Primary completion
- May 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 16 Apr 2019 (actual)
- 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.
The investigator's aim with this study is to address, with the new paradigm of tranexamic acid, the role of wound drainage following total knee arthroplasty in blood loss, blood transfusion requirements and functional recovery
Detailed description
All participants will attend a preoperatory appointment with an anaesthesiologist where preoperative haemoglobin will be optimized (Hg > 13 g/L).
Randomization will be done by opening a closed envelop with the selected group from a bag at the time of wound closure.
Collected preoperative information will include age, gender, weight, height, body-mass index, underlying diseases, operated side, haematocrit, haemoglobin level, midpatellar knee circumference and range of movement. Blood work was performed within 1 hour of the beginning of the surgery. Clinical parameters will be collected before anaesthesia.
In all cases, the surgeon will perform a medial parapatellar approach with a standard incision with the participants in the supine position. The SIGMA PFC total knee system (DePuy, Warsaw, In) and its posterior-stabilized design with a rotatory platform will be used. All participants will be under a subarachnoid spinal block.
A tourniquet will be used (pressure of 350 mmHg) from the beginning of the surgery and deflated for haemostasis before wound closure. At this time, before complete water-tight fascial closure, the patients will be allocated to group With or Without drain as described, and a drain will be placed in a subfascial position. The drain will be left clamped for 1 hour and will be left in place for 24 hours. Compressive dressings will be applied at the end of the surgery. Continuous passive motion will be started within 24 hours of surgery (0-60°, progressing as tolerated).
In all participants, about 30min before tourniquet release, intravenous tranexamic acid will be used with an initial bolus of 10 mg/kg administered in 10min followed by a perfusion of 10mg/kg over 4h. For postoperative analgesia, a femoral triangle and a popliteal block (anterior approach) will be done in all participants.
A standard fluid therapy of a balanced crystalloid solution (perfusion 10ml/kg/h) will be administered to all patients. After tourniquet release, during haemostasis and in the recovery room, an eventual need of increasing fluid therapy perfusion or a bolus will be noted in the patient's file.
Hidden blood loss will be calculated according to the haemoglobin balance method as it suggested to be the most reliable method. Total blood volume will be calculated as described by Nadler et al.
The normality of the data will be tested with the Shapiro-Wilk test/Kolmogorov-Smirnov test. The data will be compared and analyzed using Student's t-test for independent samples, or the Mann-Whitney test, according to the normality of the data. The correlation of data will be analyzed with the Pearson or Spearman correlation coefficient according to its normality. Nominal variables will be compared using the chi-square test. P-values less than 0.05 will be considered significant. Dedicated statistical software (SPSS version 21, SPSS Inc., Chicago, USA) will be used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With drain | Experimental | Procedure: Drainage of surgical woundParticipants who received a drain during surgery |
| Without drain | No intervention | –Participants who did not receive a drain during surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Consecutive patients admitted to perform a primary unilateral total knee arthroplasty
Key exclusion criteria (6 listed)
- Contraindication to take tranexamic acid
- hematologic disease with a higher risk of bleeding
- abnormal coagulation tests
- refusal of blood transfusions
- inadequate preoperatory optimization
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 |
|---|---|---|
| Drainage of surgical woundIntroduction of a drain before full fascial closure | Procedure or surgery | With drain |
Primary outcome
Total RBC loss
Time frame: 96 hours
Total red blood cells loss after surgery
Total RBC loss
Time frame: 24 hours
Total red blood cells loss after surgery
Total RBC loss
Time frame: 1 hour
Total red blood cells loss after surgery
Blood transfusion requirements
Time frame: 96 hours
Blood transfusions requirements
Knee Society Score score
Time frame: 14 days
Knee Society Score measuring function of Knee (0-100 total score, higher values, better outcome)
22 secondary outcomes
Haematocrit level
Time frame: 1 hour
Haematocrit level
Time frame: 24 hours
Haematocrit level
Time frame: 96 hours
Haemoglobin level
Time frame: 1 hour
Haemoglobin level
Time frame: 24 hours
Haemoglobin level
Time frame: 96 hours
Surgery duration
Time frame: 0hour
Length of skin incision
Time frame: 0 hour
Tourniquet duration
Time frame: 0 hour
Surgical blood loss
Time frame: 0 hour
Iron
Time frame: 96 hours
Transfusion reactions
Time frame: 96 hours
Drain volume
Time frame: 24 hours
MKC
Time frame: 48 hours
MKC
Time frame: 96 hours
MKC
Time frame: 14 days
ROM
Time frame: 48 hours
ROM
Time frame: 96 hours
ROM
Time frame: 14 days
Fluidotherapy excess
Time frame: 96 hours
Wound complications (i. e., wound dehiscence, infection)
Time frame: 14 days
Lower leg deep vein thrombosis
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2021.
- Background: PubMed 24553908Cross M, Smith E, Hoy D, Nolte S, Ackerman I, Fransen M, Bridgett L, Williams S, Guillemin F, Hill CL, Laslett LL, Jones G, Cicuttini F, Osborne R, Vos T, Buchbinder R, Woolf A, March L. The global burden of hip and knee osteoarthritis: estimates from the global burden of disease 2010 study. Ann Rheum Dis. 2014 Jul;73(7):1323-30. doi: 10.1136/annrheumdis-2013-204763. Epub 2014 Feb 19.
- Background: PubMed 15173310NIH Consensus Panel. NIH Consensus Statement on total knee replacement December 8-10, 2003. J Bone Joint Surg Am. 2004 Jun;86(6):1328-35. doi: 10.2106/00004623-200406000-00031. No abstract available.
- Background: PubMed 24122437Banerjee S, Kapadia BH, Issa K, McElroy MJ, Khanuja HS, Harwin SF, Mont MA. Postoperative blood loss prevention in total knee arthroplasty. J Knee Surg. 2013 Dec;26(6):395-400. doi: 10.1055/s-0033-1357491. Epub 2013 Oct 11.
- Background: PubMed 26961597Huang GP, Jia XF, Xiang Z, Ji Y, Wu GY, Tang Y, Li J, Zhang J. Tranexamic Acid Reduces Hidden Blood Loss in Patients Undergoing Total Knee Arthroplasty: A Comparative Study and Meta-Analysis. Med Sci Monit. 2016 Mar 10;22:797-802. doi: 10.12659/msm.895571.
- Background: PubMed 25450009Wang H, Shen B, Zeng Y. Comparison of topical versus intravenous tranexamic acid in primary total knee arthroplasty: a meta-analysis of randomized controlled and prospective cohort trials. Knee. 2014 Dec;21(6):987-93. doi: 10.1016/j.knee.2014.09.010. Epub 2014 Oct 23.
- Background: PubMed 28658157Zhang Y, Zhang JW, Wang BH. Efficacy of tranexamic acid plus drain-clamping to reduce blood loss in total knee arthroplasty: A meta-analysis. Medicine (Baltimore). 2017 Jun;96(26):e7363. doi: 10.1097/MD.0000000000007363.
- Background: PubMed 29408472Liao L, Chen Y, Tang Q, Chen YY, Wang WC. Tranexamic acid plus drain-clamping can reduce blood loss in total knee arthroplasty: A systematic review and meta-analysis. Int J Surg. 2018 Apr;52:334-341. doi: 10.1016/j.ijsu.2018.01.040. Epub 2018 Feb 3.
- Background: PubMed 23494778Craik JD, Ei Shafie SA, Kidd AG, Twyman RS. Can local administration of tranexamic acid during total knee arthroplasty reduce blood loss and transfusion requirements in the absence of surgical drains? Eur J Orthop Surg Traumatol. 2014 Apr;24(3):379-84. doi: 10.1007/s00590-013-1206-1. Epub 2013 Mar 14.
- Background: PubMed 24816760Yang Y, Lv YM, Ding PJ, Li J, Ying-Ze Z. The reduction in blood loss with intra-articular injection of tranexamic acid in unilateral total knee arthroplasty without operative drains: a randomized controlled trial. Eur J Orthop Surg Traumatol. 2015 Jan;25(1):135-9. doi: 10.1007/s00590-014-1461-9. Epub 2014 May 10.
- Background: PubMed 26521781Gao FQ, Li ZJ, Zhang K, Sun W, Zhang H. Four Methods for Calculating Blood-loss after Total Knee Arthroplasty. Chin Med J (Engl). 2015 Nov 5;128(21):2856-60. doi: 10.4103/0366-6999.168041.
- Background: PubMed 21936146Nadler SB, Hidalgo JH, Bloch T. Prediction of blood volume in normal human adults. Surgery. 1962 Feb;51(2):224-32. No abstract available.
- Individual participant dataSharing planned: No
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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.
Afonso Cardoso principal investigator
Hospital Beatriz Angelo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drainage of surgical wound in people with Osteoarthritis, Knee, run by Hospital Beatriz Ângelo at 1 site in Portugal.
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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 15 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Afonso Cardoso (00351918972882, afonso.cardoso@hbeatrizangelo.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total RBC loss (time frame: 96 hours). The study lists 5 primary outcomes in all. 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 NCT03915756, which also lists 11 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 15 Feb 2021.