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出境医 / 临床实验 / Effect of no Drainage Tube on Blood Loss and Recovery After High Tibial Osteotomy

Effect of no Drainage Tube on Blood Loss and Recovery After High Tibial Osteotomy

Study Description
Brief 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. 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.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Other: Drainage Tube Drug: Tranexamic Acid Drug: Sodium Chloride 0.9% Not Applicable

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
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of no Drainage Tube on Blood Loss and Recovery After High Tibial Osteotomy
Actual Study Start Date : August 1, 2018
Actual Primary Completion Date : September 1, 2019
Actual Study Completion Date : September 1, 2019
Arms and Interventions
Arm Intervention/treatment
Experimental: No Drainage
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.
 Drug: Tranexamic Acid
Tranexamic acid (TXA) is an anti-fibrinolytic drugcan，which can increase the stability of fibrin clots and achieve hemostasis for High tibial osteotomy'patients.
Other Name: TXA

Drug: Sodium Chloride 0.9%
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 .
Other Name: sodium chloride solution
Active Comparator: Drainage
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.
 Other: Drainage Tube
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.

Drug: Tranexamic Acid
Tranexamic acid (TXA) is an anti-fibrinolytic drugcan，which can increase the stability of fibrin clots and achieve hemostasis for High tibial osteotomy'patients.
Other Name: TXA

Drug: Sodium Chloride 0.9%
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 .
Other Name: sodium chloride solution
Outcome Measures
Primary Outcome Measures :
  1. Postoperative blood loss [ Time Frame: The third day after operation ]
    Total blood loss preoperative blood volume =(preoperative hematocrit-postoperative Hematocrit) + transfusion volume.

  2. Haemoglobin [ Time Frame: The third day after operation ]
    Reactive blood loss

  3. Hematocrit [ Time Frame: The third day after operation ]
    Reactive blood loss

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. Circumference of shank Postoperative Day One [ Time Frame: Postoperative Day One ]
    indirectly reflects the latent blood loss

  9. Circumference of shank Postoperative Day Three [ Time Frame: Postoperative Day Three ]
    indirectly reflects the latent blood loss

  10. Circumference of shank Postoperative Day Five [ Time Frame: Postoperative Day Five ]
    indirectly reflects the latent blood loss

  11. 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

  12. 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.

  13. 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.

  14. 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.

  15. Volume of drainage [ Time Frame: Postoperative Day One ]
    Reactive blood loss


Secondary Outcome Measures :
  1. Activated partial thromboplastin time [ Time Frame: The third day after operation ]
    Assessment of coagulation function in patients

  2. Prothrombin time [ Time Frame: The third day after operation ]
    Assessment of exogenous coagulation system

  3. Concentration of D-dimer [ Time Frame: The third day after operation ]
    Assessment of thrombotic diseases

  4. Concentration of Fibrinogen [ Time Frame: The third day after operation ]
    Assessment of coagulation function in patients


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Simple knee medial compartment osteoarthritis High tibial osteotomy.
  2. With varus deformity, medial proximal tibia angle <85°
  3. Unilateral High tibial osteotomy
  4. informed consent: Participants must be able to understand and voluntarily sign a written informed consent and follow the research protocol and interview process

Exclusion Criteria:

  1. patients who underwent other knee surgery within 6 months
  2. Preoperative combined anemia (Hb<100g/l)
  3. Patients with severe cardiovascular, hepatic, renal and hematopoietic diseases
  4. Patient with preoperative coagulation abnormalities 5. Patients with allergies and patients allergic to TXA.
Contacts and Locations

Locations
Layout table for location information
China, Shandong
Qilu hospital of Shandong University
Jinan, Shandong, China, 250014
Sponsors and Collaborators
Qilu Hospital of Shandong University
Investigators
Layout table for investigator information
Study Chair: Peilai Liu, Ph.D Qilu Hospital of Shandong University
Tracking Information
First Submitted Date  ICMJE May 6, 2019
First Posted Date  ICMJE May 17, 2019
Last Update Posted Date February 19, 2020
Actual Study Start Date  ICMJE August 1, 2018
Actual Primary Completion Date September 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 28, 2019)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: May 15, 2019)
  • Postoperative blood loss [ Time Frame: The day after the operation ]
    Total blood loss preoperative blood volume =(preoperative hematocrit-postoperative Hematocrit) + transfusion volume.
  • Haemoglobin [ Time Frame: The day after the operation ]
    Reactive blood loss
  • Hematocrit [ Time Frame: The day after the operation ]
    Reactive blood loss
  • Activated partial thromboplastin time [ Time Frame: The day after the operation ]
    Assessment of coagulation function in patients
  • Prothrombin time [ Time Frame: The day after the operation ]
    Assessment of exogenous coagulation system
  • Concentration of D-dimer [ Time Frame: The day after the operation ]
    Assessment of thrombotic diseases
  • Concentration of Fibrinogen [ Time Frame: The day after the operation ]
    Assessment of coagulation function in patients
  • Hospital for special surgery knee score [ Time Frame: postoperative 1 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.
  • Color doppler ultrasound of lower limb blood vessel [ Time Frame: Through study completion, an average of 1 year ]
    To determine if any thrombosis were formed
  • 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 Two [ Time Frame: Postoperative Day Two ]
    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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 28, 2019)
  • Activated partial thromboplastin time [ Time Frame: The third day after operation ]
    Assessment of coagulation function in patients
  • Prothrombin time [ Time Frame: The third day after operation ]
    Assessment of exogenous coagulation system
  • Concentration of D-dimer [ Time Frame: The third day after operation ]
    Assessment of thrombotic diseases
  • Concentration of Fibrinogen [ Time Frame: The third day after operation ]
    Assessment of coagulation function in patients
Original Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2019)
  • Circumference of shank Postoperative Day One [ Time Frame: Postoperative Day One ]
    indirectly reflects the latent blood loss
  • Circumference of shank Postoperative Day Two [ Time Frame: Postoperative Day Two ]
    indirectly reflects the latent blood loss
  • Circumference of shank Postoperative Day Three [ Time Frame: Postoperative Day Three ]
    indirectly reflects the latent blood loss
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of no Drainage Tube on Blood Loss and Recovery After High Tibial Osteotomy
Official Title  ICMJE Effect of no Drainage Tube on Blood Loss and Recovery After High Tibial Osteotomy
Brief 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. 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis, Knee
Intervention  ICMJE
  • Other: Drainage Tube
    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.
  • Drug: Tranexamic Acid
    Tranexamic acid (TXA) is an anti-fibrinolytic drugcan，which can increase the stability of fibrin clots and achieve hemostasis for High tibial osteotomy'patients.
    Other Name: TXA
  • Drug: Sodium Chloride 0.9%
    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 .
    Other Name: sodium chloride solution
Study Arms  ICMJE
  • Experimental: No Drainage
    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.
    Interventions:
    • Drug: Tranexamic Acid
    • Drug: Sodium Chloride 0.9%
  • Active Comparator: Drainage
    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.
    Interventions:
    • Other: Drainage Tube
    • Drug: Tranexamic Acid
    • Drug: Sodium Chloride 0.9%
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.
  • Palanisamy 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.
  • Suh 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.
  • Zhang 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.
  • Huang 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.
  • Chan 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.
  • Legnani 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.
  • Nishitani 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.
  • Li 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 28, 2019) 		80
Original Estimated Enrollment  ICMJE
 (submitted: May 15, 2019) 		30
Actual Study Completion Date  ICMJE September 1, 2019
Actual Primary Completion Date September 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Simple knee medial compartment osteoarthritis High tibial osteotomy.
  2. With varus deformity, medial proximal tibia angle <85°
  3. Unilateral High tibial osteotomy
  4. informed consent: Participants must be able to understand and voluntarily sign a written informed consent and follow the research protocol and interview process

Exclusion Criteria:

  1. patients who underwent other knee surgery within 6 months
  2. Preoperative combined anemia (Hb<100g/l)
  3. Patients with severe cardiovascular, hepatic, renal and hematopoietic diseases
  4. Patient with preoperative coagulation abnormalities 5. Patients with allergies and patients allergic to TXA.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03954860
Other Study ID Numbers  ICMJE 2019041
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: The datasets used and/or analysed during the current study are available from the overall study officials on reasonable request.
Responsible Party Qilu Hospital of Shandong University
Study Sponsor  ICMJE Qilu Hospital of Shandong University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Peilai Liu, Ph.D Qilu Hospital of Shandong University
PRS Account Qilu Hospital of Shandong University
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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