Osteoarthritis, KneeNCT03954860
Effect of no Drainage Tube on Blood Loss and Recovery After High Tibial Osteotomy
A study testing Drainage Tube, Tranexamic Acid and Sodium Chloride 0.9% in people with Osteoarthritis, Knee, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
The objective of this study was to evaluate the safety and efficacy of topical combined with intravenous tranexamic acid for high tibial osteotomy without placement of a drainage tube The clinical scores of patients and their possible risks were tracked. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Drainage Tube, Tranexamic Acid and Sodium Chloride 0.9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2018to 1 Sep 2019
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Simple knee medial compartment osteoarthritis High tibial osteotomy.
- With varus deformity, medial proximal tibia angle <85°
- Unilateral High tibial osteotomy
- informed consent: Participants must be able to understand and voluntarily sign a written informed consent and follow the research protocol and interview process
Who cannot join
- patients who underwent other knee surgery within 6 months
- Preoperative combined anemia (Hb<100g/l)
- Patients with severe cardiovascular, hepatic, renal and hematopoietic diseases
- Patient with preoperative coagulation abnormalities 5. Patients with allergies and patients allergic to TXA.
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study was to evaluate the safety and efficacy of topical combined with intravenous tranexamic acid for high tibial osteotomy without placement of a drainage tube The clinical scores of patients and their possible risks were tracked. The investigators hypothesized that a combination of tranexamic acid and no drainage tube could reduce blood loss and facilitate early recovery. The implementation of the study will provide a new perioperative blood loss control program for High Tibial Osteotomy, reduce the cost of hospitalization, promote patients to get out of bed early, reduce the number of days in hospital.
Read the detailed description
The condition of the patients was evaluated, and the total length of both lower limbs, anteroposterior position of knee and Mri of knee were included. The preoperative dose of tranexamic acid was calculated according to body weight of 20 mg / kg, 100 ml of tranexamic acid sodium chloride solution was dripped 30 minutes before operation, and after incision closure, 30 ml of normal saline solution containing 2 g of tranexamic acid was injected through drainage tube or subcutaneously. Postoperative intravenous drip of 100 ML sodium chloride solution containing 20 mg / kg tranexamic acid. Arthroscopy was first used to further confirm the cartilage defect, and a new type of lower limb alignment meter and a customized precise osteotomy template were used to perform the osteotomy according to the preoperative plan. One group was not placed drainage tube, the other group was placed drainage tube. Visual analogue pain score (Vas) and American Special Surgical Hospital (HSS) knee function score were recorded 3 month after surgery. Throughout the trial, the investigators will carefully observe and manage your complications and the outcome of your surgery.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Drainage Tube, Tranexamic Acid, Sodium Chloride 0.9%
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drainage TubeOther
The drainage tube drainage to guide the pus, blood and liquid accumulated between human tissues or in body cavity outside the body of High tibial osteotomy'patients.
Tranexamic AcidDrug
Also called TXA
Tranexamic acid (TXA) is an anti-fibrinolytic drugcan，which can increase the stability of fibrin clots and achieve hemostasis for High tibial osteotomy'patients.
Sodium Chloride 0.9%Drug
Also called sodium chloride solution
Sodium Chloride 0.9% is a solution of sodium chloride, which has the same osmotic pressure as animal or human plasma in physiological experiments or clinics, and can be used to dilute Tranexamic Acid .
| Study group | Role | What they receive |
|---|---|---|
| No Drainage | Experimental | The preoperative dose of tranexamic acid was calculated according to 20 mg / kg body weight, 100 ml of tranexamic acid sodium chloride solution was dripped 30 minutes before operation, and 30 ml saline containing 2 g tranexamic acid was applied to the local area before loosening the tourniquet.Postoperative intravenous drip of 100 ML sodium chloride solution containing 20 mg / kg tranexamic acid. No drainage tube was placed after operation. Receives: Drug: Tranexamic Acid; Drug: Sodium Chloride 0.9% |
| Drainage | Active comparator | The preoperative dose of tranexamic acid was calculated according to 20 mg / kg body weight, 100 ml of tranexamic acid sodium chloride solution was dripped 30 minutes before operation, and 30 ml saline containing 2 g tranexamic acid was applied to the local area before loosening the tourniquet.Postoperative intravenous drip of 100 ML sodium chloride solution containing 20 mg / kg tranexamic acid. Drainage tube should be placed after operation. Receives: Other: Drainage Tube; Drug: Tranexamic Acid; Drug: Sodium Chloride 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative blood loss
Total blood loss preoperative blood volume =(preoperative hematocrit-postoperative Hematocrit) + transfusion volume.
Measured: The third day after operation
Haemoglobin
Reactive blood loss
Measured: The third day after operation
Hematocrit
Reactive blood loss
Measured: The third day after operation
Hospital for special surgery knee score
HSS is a knee function scoring system with a full score of 100. 0 means the loss of knee function, 100 means the best knee function, and the greater the value, the better knee function.
Measured: postoperative 3 month
Visual Analogue Scale Postoperative Day One
Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.
Measured: Postoperative Day One
Visual Analogue Scale Postoperative Day Three
Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.
Measured: Postoperative Day Three
Visual Analogue Scale Postoperative Day Five
Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.
Measured: Postoperative Day Five
Circumference of shank Postoperative Day One
indirectly reflects the latent blood loss
Measured: Postoperative Day One
Circumference of shank Postoperative Day Three
indirectly reflects the latent blood loss
Measured: Postoperative Day Three
Circumference of shank Postoperative Day Five
indirectly reflects the latent blood loss
Measured: Postoperative Day Five
Number of blood transfusions
If the hemoglobin was <80 g/l, allogeneic blood was transfused, and the number of blood transfusions were recorded.0 means no blood transfusion, and the larger the number is, the more blood transfusion.The maximum number does not exceed the total number of patients
Measured: Postoperative Day Three
Number of Incision infection
The incision was red, swollen, hot and painful, and the blood routine showed that the leukocyte was increased.
Measured: postoperative 3 month
Number of hematoma formation
After operation, the incision is swollen and has wave motion, but it is not hot or painful, and there will be blood outflow during puncture.
Measured: postoperative 3 month
Number of delayed healing of the incision.
On the 14th day after operation, the incision did not heal.
Measured: On the 14th day after operation
Volume of drainage
Reactive blood loss
Measured: Postoperative Day One
Secondary outcomes (4)
Activated partial thromboplastin time
Assessment of coagulation function in patients
Measured: The third day after operation
Prothrombin time
Assessment of exogenous coagulation system
Measured: The third day after operation
Concentration of D-dimer
Assessment of thrombotic diseases
Measured: The third day after operation
Concentration of Fibrinogen
Assessment of coagulation function in patients
Measured: The third day after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2019
- Study start1 Aug 2018
- Primary completion1 Sep 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peilai Liu, Ph.D, Study chair, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03954860
- Sponsor's protocol ID
- 2019041
- Status last verified
- May 2019
- First submitted
- 6 May 2019
- Last updated
- 19 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets used and/or analysed during the current study are available from the overall study officials on reasonable request.
Publications
Kim KI, Kim HJ, Kim GB, Bae SH. Tranexamic acid is effective for blood management in open-wedge high tibial osteotomy. Orthop Traumatol Surg Res. 2018 Nov;104(7):1003-1007. doi: 10.1016/j.otsr.2018.07.019. Epub 2018 Sep 20.
PubMed 30245067Palanisamy JV, Das S, Moon KH, Kim DH, Kim TK. Intravenous Tranexamic Acid Reduces Postoperative Blood Loss After High Tibial Osteotomy. Clin Orthop Relat Res. 2018 Nov;476(11):2148-2154. doi: 10.1097/CORR.0000000000000378.
PubMed 29939895Suh DW, Kyung BS, Han SB, Cheong K, Lee WH. Efficacy of Tranexamic Acid for Hemostasis in Patients Undergoing High Tibial Osteotomy. J Knee Surg. 2018 Jan;31(1):50-55. doi: 10.1055/s-0037-1600091. Epub 2017 Mar 29.
PubMed 28355682Zhang Q, Zhang Q, Guo W, Liu Z, Cheng L, Zhu G. No need for use of drainage after minimally invasive unicompartmental knee arthroplasty: a prospective randomized, controlled trial. Arch Orthop Trauma Surg. 2015 May;135(5):709-13. doi: 10.1007/s00402-015-2192-z. Epub 2015 Mar 8.
PubMed 25750137Huang Z, Xie X, Li L, Huang Q, Ma J, Shen B, Kraus VB, Pei F. Intravenous and Topical Tranexamic Acid Alone Are Superior to Tourniquet Use for Primary Total Knee Arthroplasty: A Prospective, Randomized Controlled Trial. J Bone Joint Surg Am. 2017 Dec 20;99(24):2053-2061. doi: 10.2106/JBJS.16.01525.
PubMed 29257010Chan JJ, Cirino CM, Huang HH, Poeran J, Mazumdar M, Parsons BO, Anthony SG, Galatz LM, Cagle PJ Jr. Drain Use is Associated with Increased Odds of Blood Transfusion in Total Shoulder Arthroplasty: A Population-Based Study. Clin Orthop Relat Res. 2019 Jul;477(7):1700-1711. doi: 10.1097/CORR.0000000000000728.
PubMed 30985612Legnani C, Oriani G, Parente F, Ventura A. Reducing transfusion requirements following total knee arthroplasty: effectiveness of a double infusion of tranexamic acid. Eur Rev Med Pharmacol Sci. 2019 Mar;23(5):2253-2256. doi: 10.26355/eurrev_201903_17273.
PubMed 30915773Nishitani K, Kuriyama S, Nakamura S, Ito H, Matsuda S. A Multivariate Analysis on the Effect of No Closed Suction Drain on the Length of Hospital Stay in Total Knee Arthroplasty. Knee Surg Relat Res. 2019 Mar 1;31(1):25-30. doi: 10.5792/ksrr.18.013.
PubMed 30871289Li S, Yang J, Watson C, Lu Q, Zhang M, Miao Z, Luo D, Liu P. Drainage relieves pain without increasing post-operative blood loss in high tibial osteotomy: a prospective randomized controlled study. Int Orthop. 2020 Jun;44(6):1037-1043. doi: 10.1007/s00264-020-04530-z. Epub 2020 Mar 14.
PubMed 32172314
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of no Drainage Tube on Blood Loss and Recovery After High Tibial Osteotomy
- ClinicalTrials.gov ID
- NCT03954860
- Acronym / sponsor ID
- 2019041
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 17 May 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 objective of this study was to evaluate the safety and efficacy of topical combined with intravenous tranexamic acid for high tibial osteotomy without placement of a drainage tube The clinical scores of patients and their possible risks were tracked. The investigators hypothesized that a combination of tranexamic acid and no drainage tube could reduce blood loss and facilitate early recovery. The implementation of the study will provide a new perioperative blood loss control program for High Tibial Osteotomy, reduce the cost of hospitalization, promote patients to get out of bed early, reduce the number of days in hospital.
Detailed description
The condition of the patients was evaluated, and the total length of both lower limbs, anteroposterior position of knee and Mri of knee were included. The preoperative dose of tranexamic acid was calculated according to body weight of 20 mg / kg, 100 ml of tranexamic acid sodium chloride solution was dripped 30 minutes before operation, and after incision closure, 30 ml of normal saline solution containing 2 g of tranexamic acid was injected through drainage tube or subcutaneously. Postoperative intravenous drip of 100 ML sodium chloride solution containing 20 mg / kg tranexamic acid. Arthroscopy was first used to further confirm the cartilage defect, and a new type of lower limb alignment meter and a customized precise osteotomy template were used to perform the osteotomy according to the preoperative plan. One group was not placed drainage tube, the other group was placed drainage tube. Visual analogue pain score (Vas) and American Special Surgical Hospital (HSS) knee function score were recorded 3 month after surgery. Throughout the trial, the investigators will carefully observe and manage your complications and the outcome of your surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Drainage | Experimental | Drug: Tranexamic Acid, Drug: Sodium Chloride 0.9%The preoperative dose of tranexamic acid was calculated according to 20 mg / kg body weight, 100 ml of tranexamic acid sodium chloride solution was dripped 30 minutes before operation, and 30 ml saline containing 2 g tranexamic acid was applied to the local area before loosening the tourniquet.Postoperative intravenous drip of 100 ML sodium chloride solution containing 20 mg / kg tranexamic acid. No drainage tube was placed after operation. |
| Drainage | Active comparator | Other: Drainage Tube, Drug: Tranexamic Acid, Drug: Sodium Chloride 0.9%The preoperative dose of tranexamic acid was calculated according to 20 mg / kg body weight, 100 ml of tranexamic acid sodium chloride solution was dripped 30 minutes before operation, and 30 ml saline containing 2 g tranexamic acid was applied to the local area before loosening the tourniquet.Postoperative intravenous drip of 100 ML sodium chloride solution containing 20 mg / kg tranexamic acid. Drainage tube should be placed after operation. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Simple knee medial compartment osteoarthritis High tibial osteotomy.
- With varus deformity, medial proximal tibia angle <85°
- Unilateral High tibial osteotomy
- informed consent: Participants must be able to understand and voluntarily sign a written informed consent and follow the research protocol and interview process
Key exclusion criteria (4 listed)
- patients who underwent other knee surgery within 6 months
- Preoperative combined anemia (Hb<100g/l)
- Patients with severe cardiovascular, hepatic, renal and hematopoietic diseases
- Patient with preoperative coagulation abnormalities 5. Patients with allergies and patients allergic to TXA.
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 TubeThe drainage tube drainage to guide the pus, blood and liquid accumulated between human tissues or in body cavity outside the body of High tibial osteotomy'patients. | Other | Drainage |
| Tranexamic AcidAlso: TXATranexamic acid (TXA) is an anti-fibrinolytic drugcan，which can increase the stability of fibrin clots and achieve hemostasis for High tibial osteotomy'patients. | Drug | Drainage, No Drainage |
| Sodium Chloride 0.9%Also: sodium chloride solutionSodium Chloride 0.9% is a solution of sodium chloride, which has the same osmotic pressure as animal or human plasma in physiological experiments or clinics, and can be used to dilute Tranexamic Acid . | Drug | Drainage, No Drainage |
Primary outcome
Postoperative blood loss
Time frame: The third day after operation
Total blood loss preoperative blood volume =(preoperative hematocrit-postoperative Hematocrit) + transfusion volume.
Haemoglobin
Time frame: The third day after operation
Reactive blood loss
Hematocrit
Time frame: The third day after operation
Reactive blood loss
Hospital for special surgery knee score
Time frame: postoperative 3 month
HSS is a knee function scoring system with a full score of 100. 0 means the loss of knee function, 100 means the best knee function, and the greater the value, the better knee function.
Visual Analogue Scale Postoperative Day One
Time frame: Postoperative Day One
Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.
Visual Analogue Scale Postoperative Day Three
Time frame: Postoperative Day Three
Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.
Visual Analogue Scale Postoperative Day Five
Time frame: Postoperative Day Five
Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.
Circumference of shank Postoperative Day One
Time frame: Postoperative Day One
indirectly reflects the latent blood loss
Circumference of shank Postoperative Day Three
Time frame: Postoperative Day Three
indirectly reflects the latent blood loss
Circumference of shank Postoperative Day Five
Time frame: Postoperative Day Five
indirectly reflects the latent blood loss
Number of blood transfusions
Time frame: Postoperative Day Three
If the hemoglobin was <80 g/l, allogeneic blood was transfused, and the number of blood transfusions were recorded.0 means no blood transfusion, and the larger the number is, the more blood transfusion.The maximum number does not exceed the total number of patients
Number of Incision infection
Time frame: postoperative 3 month
The incision was red, swollen, hot and painful, and the blood routine showed that the leukocyte was increased.
Number of hematoma formation
Time frame: postoperative 3 month
After operation, the incision is swollen and has wave motion, but it is not hot or painful, and there will be blood outflow during puncture.
Number of delayed healing of the incision.
Time frame: On the 14th day after operation
On the 14th day after operation, the incision did not heal.
Volume of drainage
Time frame: Postoperative Day One
Reactive blood loss
4 secondary outcomes
Activated partial thromboplastin time
Time frame: The third day after operation
Prothrombin time
Time frame: The third day after operation
Concentration of D-dimer
Time frame: The third day after operation
Concentration of Fibrinogen
Time frame: The third day after operation
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 19 Feb 2020.
- Background: PubMed 30245067Kim KI, Kim HJ, Kim GB, Bae SH. Tranexamic acid is effective for blood management in open-wedge high tibial osteotomy. Orthop Traumatol Surg Res. 2018 Nov;104(7):1003-1007. doi: 10.1016/j.otsr.2018.07.019. Epub 2018 Sep 20.
- Background: PubMed 29939895Palanisamy JV, Das S, Moon KH, Kim DH, Kim TK. Intravenous Tranexamic Acid Reduces Postoperative Blood Loss After High Tibial Osteotomy. Clin Orthop Relat Res. 2018 Nov;476(11):2148-2154. doi: 10.1097/CORR.0000000000000378.
- Background: PubMed 28355682Suh DW, Kyung BS, Han SB, Cheong K, Lee WH. Efficacy of Tranexamic Acid for Hemostasis in Patients Undergoing High Tibial Osteotomy. J Knee Surg. 2018 Jan;31(1):50-55. doi: 10.1055/s-0037-1600091. Epub 2017 Mar 29.
- Background: PubMed 25750137Zhang Q, Zhang Q, Guo W, Liu Z, Cheng L, Zhu G. No need for use of drainage after minimally invasive unicompartmental knee arthroplasty: a prospective randomized, controlled trial. Arch Orthop Trauma Surg. 2015 May;135(5):709-13. doi: 10.1007/s00402-015-2192-z. Epub 2015 Mar 8.
- Background: PubMed 29257010Huang Z, Xie X, Li L, Huang Q, Ma J, Shen B, Kraus VB, Pei F. Intravenous and Topical Tranexamic Acid Alone Are Superior to Tourniquet Use for Primary Total Knee Arthroplasty: A Prospective, Randomized Controlled Trial. J Bone Joint Surg Am. 2017 Dec 20;99(24):2053-2061. doi: 10.2106/JBJS.16.01525.
- Background: PubMed 30985612Chan JJ, Cirino CM, Huang HH, Poeran J, Mazumdar M, Parsons BO, Anthony SG, Galatz LM, Cagle PJ Jr. Drain Use is Associated with Increased Odds of Blood Transfusion in Total Shoulder Arthroplasty: A Population-Based Study. Clin Orthop Relat Res. 2019 Jul;477(7):1700-1711. doi: 10.1097/CORR.0000000000000728.
- Background: PubMed 30915773Legnani C, Oriani G, Parente F, Ventura A. Reducing transfusion requirements following total knee arthroplasty: effectiveness of a double infusion of tranexamic acid. Eur Rev Med Pharmacol Sci. 2019 Mar;23(5):2253-2256. doi: 10.26355/eurrev_201903_17273.
- Background: PubMed 30871289Nishitani K, Kuriyama S, Nakamura S, Ito H, Matsuda S. A Multivariate Analysis on the Effect of No Closed Suction Drain on the Length of Hospital Stay in Total Knee Arthroplasty. Knee Surg Relat Res. 2019 Mar 1;31(1):25-30. doi: 10.5792/ksrr.18.013.
- Derived from this study: PubMed 32172314Li S, Yang J, Watson C, Lu Q, Zhang M, Miao Z, Luo D, Liu P. Drainage relieves pain without increasing post-operative blood loss in high tibial osteotomy: a prospective randomized controlled study. Int Orthop. 2020 Jun;44(6):1037-1043. doi: 10.1007/s00264-020-04530-z. Epub 2020 Mar 14.
- Individual participant dataSharing planned: No. The datasets used and/or analysed during the current study are available from the overall study officials on reasonable request.
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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.
Peilai Liu, Ph.D study chair
Qilu Hospital of Shandong University
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 Tube, Tranexamic Acid and Sodium Chloride 0.9% in people with Osteoarthritis, Knee, run by Qilu Hospital of Shandong University at 1 site in China.
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 4 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 19 Feb 2020. 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 China. 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?
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?
Postoperative blood loss (time frame: The third day after operation). The study lists 15 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 NCT03954860, which also lists 9 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 19 Feb 2020.