Ignite Creation Date:
2024-05-06 @ 7:15 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05947435
Status:
COMPLETED
Last Update Posted:
2023-07-19
First Post:
2023-07-07
Brief Title:
Tranexamic Acid in Percutaneous Nephrolithotomy
Sponsor:
Haseki Training and Research Hospital
Organization:
Haseki Training and Research Hospital
Study Overview
Official Title:
The Effect of Use of Tranexamic Acid in Percutaneous Nephrolithotomy on Blood Loss and Surgical Visual Clarity
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Tranexamic acid once a randomly used antifibrinolytic agent has been in standard protocols for many specific surgeries Studies are still needed to standardize the dose and route of tranexamic acid administration examine its possible contributions in urological surgery and establish a protocol for its use
To contribute to this goal the study was designed as a prospective randomized double-blind study on 75 patients with one control and 2 study groups n25 who underwent percutaneous nephrolithotomy Group Tranexamic acid received 10 mgkg intravenous tranexamic acid preoperatively And Group Irrigation received the same amount in the initial irrigation fluid Primarilythe total amount of blood transfusion and the changes in haemoglobin and haematocrit values during two postoperative days were observed Distinctively continuous intraoperative haemoglobin saturation was monitored Secondarily surgical visual clarity with a standard visual score was questioned to reveal its contribution to surgical practicality operative time and residual fragment quantity
To contribute to this goal the study was designed as a prospective randomized double-blind study on 75 patients with one control and 2 study groups n25 who underwent percutaneous nephrolithotomy Group Tranexamic acid received 10 mgkg intravenous tranexamic acid preoperatively And Group Irrigation received the same amount in the initial irrigation fluid Primarilythe total amount of blood transfusion and the changes in haemoglobin and haematocrit values during two postoperative days were observed Distinctively continuous intraoperative haemoglobin saturation was monitored Secondarily surgical visual clarity with a standard visual score was questioned to reveal its contribution to surgical practicality operative time and residual fragment quantity
Detailed Description:
The study was designed as a double-blind prospective randomised controlled study after approval of our Institutional ethics committee dossier no 108-2021 and assessed patients scheduled for PCNL after January 2022 for eligibility After obtaining written informed consent 75 patients 3 groups 111 distribution n25 were allocated and the study was conducted in Haseki Training and Research Hospital until May 2023 with the principles outlined in the Helsinki Declaration
Study subjects The study population was 18-70 years old and ASA I-III patients scheduled for PCNL surgery Exclusion criteria were tranexamic acid hypersensitivity history of subarachnoid haemorrhage previous cerebrovascular event a history of arterial-venous embolism or a tendency to thromboembolism abnormal liver function tests unstable cardiovascular disease acute or chronic renal failure presence of any haematological disease and known colour blindness
Patient randomization and blindness Randomization was designed as 3 n 25 named Groups A B and Group C in a 111 ratio with a computer-based algorithm and sealed in opaque envelopes by the surgeon assigned to the study The investigative anesthesiologist selected an envelope in the order of numbers on it and Group A continued with an IV infusion of 10 mgkg tranexamic acid for 20 minutes just before the surgical incision In Group B 10 mgkg tranexamic acid was placed in the first irrigation solution in Group C no drug was given either way The urologist was blind to the study groups and was the evaluator of an intraoperative visual score Postoperative Hb and Hct values and complications were followed by the surgeons who were also blinded to the groups and the decision of blood replacement was made according to the Hct values according to our standard protocol of the urology department
Anaesthesia and surgical technique All surgeries were performed under general anaesthesia with standard monitorisation and non-invasive MASIMO Hemoglobin SpHb real-time monitoring After the ureteral catheter was placed the patient was placed in a prone position After sequential dilatations were performed under fluoroscopy a 165 Fr or 21 Fr am Platz sheath was placed in the pelvicalyceal system Ho YAG Laser lithotripter Sphinx Lisa laser USA was used to fragment stones According to the surgeons decision a JJ stent andor a nephrostomy tube were placed at the final of the operation
Primary outcome The primary outcome was the comparison of changes in haemoglobin and haematocrit values during two postoperative days with changes in intraoperative SpHb values and postoperative need for blood transfusion SpHb was monitored throughout the surgery however the value of change before and immediately after surgery was a major concern Blood samples were evaluated for Hb and Hct values on the first night and the second morning after surgery Indications for blood transfusion were below 30 hematocrit level
Secondary outcomes The effect on surgical outcomes was questioned by residual fragment and postoperative complications The effect on surgical practice was evaluated by operation time minute and visual score of the surgeon At the end of the surgery the assigned surgeon who was blind to the groups was asked to rate the visual clarity by a score pre-designed for arthroscopic surgeries as Bad-Medium Good or Perfect A visual scoring from 1 to 10 was used with 10 for the perfect image 4-10 as good and 1-4 as bad-medium We searched for bleeding angioembolisation infection reoperation and thrombotic complications especially pulmonary emboli
Statistical analysis and sample size calculation The mean sample size was calculated using the G Power 31 analysis program The sample size was estimated at 90 power and 8 significance level and it was determined that at least 20 patients per group were required to obtain a statistically significant value Therefore we included 25 patients in each group to prevent possible dropouts
The Statistical Package for the Social Sciences version 27 SPSS IBM Corp Armonk NY USA program was used The normality of the distribution of the variables was checked by the Shapiro-Wilk test and Q-Q plots The one-way ANOVA test or Kruskal-Wallis test was used for the comparison of continuous variables Comparison between groups was performed with Tukey posthoc analysis Qualitative data are shown as mean standard deviation or median IQR Quantitative data are shown as mean standard deviation values The data were analyzed at a 95 confidence level
Study subjects The study population was 18-70 years old and ASA I-III patients scheduled for PCNL surgery Exclusion criteria were tranexamic acid hypersensitivity history of subarachnoid haemorrhage previous cerebrovascular event a history of arterial-venous embolism or a tendency to thromboembolism abnormal liver function tests unstable cardiovascular disease acute or chronic renal failure presence of any haematological disease and known colour blindness
Patient randomization and blindness Randomization was designed as 3 n 25 named Groups A B and Group C in a 111 ratio with a computer-based algorithm and sealed in opaque envelopes by the surgeon assigned to the study The investigative anesthesiologist selected an envelope in the order of numbers on it and Group A continued with an IV infusion of 10 mgkg tranexamic acid for 20 minutes just before the surgical incision In Group B 10 mgkg tranexamic acid was placed in the first irrigation solution in Group C no drug was given either way The urologist was blind to the study groups and was the evaluator of an intraoperative visual score Postoperative Hb and Hct values and complications were followed by the surgeons who were also blinded to the groups and the decision of blood replacement was made according to the Hct values according to our standard protocol of the urology department
Anaesthesia and surgical technique All surgeries were performed under general anaesthesia with standard monitorisation and non-invasive MASIMO Hemoglobin SpHb real-time monitoring After the ureteral catheter was placed the patient was placed in a prone position After sequential dilatations were performed under fluoroscopy a 165 Fr or 21 Fr am Platz sheath was placed in the pelvicalyceal system Ho YAG Laser lithotripter Sphinx Lisa laser USA was used to fragment stones According to the surgeons decision a JJ stent andor a nephrostomy tube were placed at the final of the operation
Primary outcome The primary outcome was the comparison of changes in haemoglobin and haematocrit values during two postoperative days with changes in intraoperative SpHb values and postoperative need for blood transfusion SpHb was monitored throughout the surgery however the value of change before and immediately after surgery was a major concern Blood samples were evaluated for Hb and Hct values on the first night and the second morning after surgery Indications for blood transfusion were below 30 hematocrit level
Secondary outcomes The effect on surgical outcomes was questioned by residual fragment and postoperative complications The effect on surgical practice was evaluated by operation time minute and visual score of the surgeon At the end of the surgery the assigned surgeon who was blind to the groups was asked to rate the visual clarity by a score pre-designed for arthroscopic surgeries as Bad-Medium Good or Perfect A visual scoring from 1 to 10 was used with 10 for the perfect image 4-10 as good and 1-4 as bad-medium We searched for bleeding angioembolisation infection reoperation and thrombotic complications especially pulmonary emboli
Statistical analysis and sample size calculation The mean sample size was calculated using the G Power 31 analysis program The sample size was estimated at 90 power and 8 significance level and it was determined that at least 20 patients per group were required to obtain a statistically significant value Therefore we included 25 patients in each group to prevent possible dropouts
The Statistical Package for the Social Sciences version 27 SPSS IBM Corp Armonk NY USA program was used The normality of the distribution of the variables was checked by the Shapiro-Wilk test and Q-Q plots The one-way ANOVA test or Kruskal-Wallis test was used for the comparison of continuous variables Comparison between groups was performed with Tukey posthoc analysis Qualitative data are shown as mean standard deviation or median IQR Quantitative data are shown as mean standard deviation values The data were analyzed at a 95 confidence level
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None