Central Venous PressureNCT06237751
Preoperative Sildenafil Administration for Hepatectomy
A study testing Sildenafil 100 MG in people with Central Venous Pressure and Hepatectomy, run by First People's Hospital of Chenzhou at 1 site in China.
Trial summary
Hepatectomy is an important treatment for liver diseases, and bleeding is one of the most common complications during dissection of the liver parenchyma. The Control Low Central Venous Pressure (CLCVP) technique is currently one of the most important techniques to control intraoperative bleeding. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Central Venous Pressure, Hepatectomy, Hemodynamics Instability
- What is being tested?
- Sildenafil 100 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2024to 30 Dec 2024
- 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients undergoing hepatic resection
- age from 18-85 years
- Child-Pugh ≤B
- ASA II-III
- willing to join the trial.
Who cannot join
- Pregnancy or Lactation
- Known Allergy to any Medications used in the Study
- Hemoglobin (Hb) < 90 g/L
- Body Mass Index (BMI) > 35 kg/m2 or < 18 kg/m2
- Hypertension > 180 mmHg
- Renal Impairment (Creatinine, Cr 178 µmol/L)
- Severe Cardiovascular Diseases including Active Coronary Artery Disease, Severe Valve Stenosis and Hypertrophic Obstructive Cardiomyopathy, History of Stroke Within Six Months.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhiming Zhang
Chenzhou, Hunan, 423000
Zhiming Zhang, M.D., +8613875555649, otc0735@163.com
About this study
Hepatectomy is an important treatment for liver diseases, and bleeding is one of the most common complications during dissection of the liver parenchyma. The Control Low Central Venous Pressure (CLCVP) technique is currently one of the most important techniques to control intraoperative bleeding. It mainly consists of fluid restriction, position adjustment, and the use of vasodilators. However, these measures focus on decreasing CVP by reducing the volume of return blood, and less attention is paid to factors such as pulmonary vascular resistance and cardiac function. Sildenafil, known as Viagra, is currently used to treat erectile dysfunction and pulmonary hypertension in men. Its action inhibits phosphodiesterase-5 (PDE-5) and increases cGMP levels, leading to smooth muscle relaxation and vasodilation. Its pharmacological properties provide potential value for the treatment of many diseases. However, few studies have been conducted both domestically and internationally on the use of sildenafil citrate in liver resection related to CLCVP. This study aims to investigate the influence of preoperative oral administration of Sildenafil Citrate combined with IPM on IBL and surgical results during open or laparoscopic hepatectomy, as well as its safety and feasibility. It is expected to provide an innovative management optimization plan for reducing the bleeding in hepatectomy and to provide empirical support for the potential value of Sildenafil Citrate or Sildenafil-like drugs in improving the safety and quality of perioperative hepatectomy patients.
Read the detailed description
- Feasibility/Effectiveness evaluation indicators: Primary outcomes：
- Intraoperative blood loss: To quantify the IBL by calculating the amount of blood in the suction bottle (actual blood loss amount - saline irrigation amount) and the weight of the gauze blood pad ((weight of the gauze block after blood absorption in g - weight of the gauze block before blood absorption in g) / 1.054 (average density of blood in g/ml)).
- The classification of the surgical field: At T3 and T4, the surgeon will rate and score the liver surgical field according to Table 2. If the score is lower than 70 points, CLCVP technique will be initiated to improve the surgical conditions. At T5, the surgeon will re-evaluate the surgical field to assess the effectiveness of the CLCVP technique. At the same time, the surgeon will independently evaluate the performance of the anesthesiologist in controlling surgical field and ensuring the patient's safety, so as to comprehensively reflect the contribution of anesthesia management to the surgery. To ensure the objectivity of the assessment, the lead surgeon will remain blind to the patient group situation throughout the process. Secondary outcomes:
- Cumulative consumption of nitroglycerine: Based on the criterion of CLCVP, record whether the patient needs to use nitroglycerine during the operation and the dose used.
- Hemodynamic parameters: Collect data such as SBP, DBP, MAP, CVP, CO, SV, SVV, SVR, HR, SpO2 at the time when the patient enters the operating room (T0), after induction (T1), 15 minutes after adjusting the body position (T2), 30 minutes after the start of liver resection (T3), 60 minutes after the start of liver resection (T4), after liver resection (T5), and at the end of the operation (T6) to assess the influence of sildenafil on the intraoperative hemodynamic stability.
- Safety evaluation indicators:
- Blood gas analysis: Measure Hb, PH, and Lac at T1, T3, T4, and T5 to understand the patient's internal environment status.
- Coagulation function：Understand the changes in the coagulation function of the patient during the operation by measuring the TEG of the patient at T2 and T5, and measure the APTT and PT values at D1, D3, and D5 to understand whether there is an impact on the patient's postoperative coagulation function after taking Sildenafil.
- Intraoperative urine output: By recording the intraoperative urine output value of the patient at T6.
- Adverse events in the recovery room：It is evaluated by measuring whether the patient has hypotension and whether there is hypoxemia in the recovery room.
- Biochemical markers (Liver and kidney functions): It is evaluated by measuring the levels of TBil, Alb, AST, ALT, Cr, BUN of the patients on days -D1, D1, D3, and D5.
- Complete blood count: At -D1, D1, D3, and D5, it is evaluated by measuring the patient's postoperative Hb, Plt, and Hct.
- Cardiac function: By comparing the levels of BNP, CK-MB, and cTn of the patients on days D1 to assess whether Sildenafil has an impact on the patient's cardiac function.
- Postoperative hospital stay and drainage indwelling time: Record the patient's hospital stay and drainage tube placement time to assess the patient's recovery speed.
- Postoperative complications: Whether to enter the ICU after surgery, liver failure, bleeding, bile leakage, ascites, pleural effusion, and incision site infection.
- (- D1: The day before surgery; - T0: half an hour before surgery; T0: entering the operating room; T1: post induction; T2: 5 minutes after 30° head-up and foot-down position; T3: 30 minutes after the start of liver resection; T4: 60 minutes after the start of liver resection; T5: after liver resection; T6: at the end of the operation; D1: Postoperative day 1; D3: Postoperative day 3; D5: Postoperative day 5)
- Being tested
- Sildenafil 100 MG
- Keywords
- Sildenafil Citrate, Hepatectomy, Laparoscopy, Low central venous pressure, Study protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sildenafil 100 MGDrug
Also called nitroglycerine
Sildenafil 100mg orally half an hour before surgery
| Study group | Role | What they receive |
|---|---|---|
| calcium tablet | Other | calcium tablet Receives: Drug: Sildenafil 100 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative blood loss
To quantify the IBL by calculating the amount of blood in the suction bottle (actual blood loss amount - saline irrigation amount) and the weight of the gauze blood pad ((weight of the gauze block after blood absorption in g - weight of the gauze block before blood absorption in g) / 1.054 (average density of blood in g/ml)).
Measured: At the end of the operation
The classification of the surgical field
At T3 and T4, the surgeon will rate and score the liver surgical field according to Table 2. If the score is lower than 70 points, CLCVP technique will be initiated to improve the surgical conditions. At T5, the surgeon will re-evaluate the surgical field to assess the effectiveness of the CLCVP technique. At the same time, the surgeon will independently evaluate the performance of the anesthesiologist in controlling surgical field and ensuring the patient's safety, so as to comprehensively reflect the contribution of anesthesia management to the surgery. To ensure the objectivity of the assessment, the lead surgeon will remain blind to the patient group situation throughout the process.(At 30 minutes after the start of liver resection(T3), 60 minutes after the start of liver resection(T4) and after liver resection(T5))
Measured: At the end of the operation
Secondary outcomes (12)
Cumulative consumption of nitroglycerine
Based on the criterion of CLCVP, record whether the patient needs to use nitroglycerine during the operation and the dose used.
Measured: At the end of the operation
Hemodynamic parameters
Collect data such as SBP, DBP, MAP, CVP, CO, SV, SVV, SVR, HR, SpO2 at the time when the patient enters the operating room (T0), after induction (T1), 15 minutes after adjusting the body position (T2), 30 minutes after the start of liver resection (T3), 60 minutes after the start of liver resection (T4), after liver resection (T5), and at the end of the operation (T6) to assess the influence of sildenafil on the intraoperative hemodynamic stability.
Measured: At the end of the operation
Blood gas analysis
Measure Hb, PH, and Lac at T1, T3, T4, and T5 to understand the patient's internal environment status.(At post induction(T1), 5 minutes after 30° head-up and foot-down position(T2), 30 minutes after the start of liver resection(T3), 60 minutes after the start of liver resection(T4) and after liver resection(T5))
Measured: At the end of the operation
Intraoperative urine output
By recording the intraoperative urine output value of the patient at T6.
Measured: At the end of the operation(T6)
Adverse events in the recovery room
It is evaluated by measuring whether the patient has hypotension and whether there is hypoxemia in the recovery room.
Measured: After the end of surgery, Patient in recovery room.
Liver function
It is evaluated by measuring the levels of TBil, Alb, AST, ALT of the patients on days -D1, D1, D3, and D5.
Measured: At the day before surgery(-D1), postoperative day 1(D1), postoperative day 3(D3) and postoperative day 5(D5).
kidney function
It is evaluated by measuring the levels of Cr, BUN of the patients on days -D1, D1, D3, and D5.
Measured: At the day before surgery(-D1), postoperative day 1(D1), postoperative day 3(D3) and postoperative day 5(D5).
Complete blood count
At -D1, D1, D3, and D5, it is evaluated by measuring the patient's postoperative Hb, Plt, and Hct.
Measured: At the day before surgery(-D1), postoperative day 1(D1), postoperative day 3(D3) and postoperative day 5(D5).
Cardiac function
By comparing the levels of BNP, CK-MB, and cTn of the patients on days D1 to assess whether Sildenafil has an impact on the patient's cardiac function.
Measured: At Postoperative day 1
Postoperative hospital stay
Record the patient's hospital stay to assess the patient's recovery speed.
Measured: At Postoperative day 5
Drainage indwelling time
Record the drainage tube placement time to assess the patient's recovery speed.
Measured: At Postoperative day 5
Postoperative complications
Whether to enter the ICU after surgery, liver failure, bleeding, bile leakage, ascites, pleural effusion, and incision site infection.
Measured: At postoperative day 1, postoperative day 3 and postoperative day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start1 Feb 2024
- Primary completion30 Oct 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Central Venous PressureStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The investigators planned a study to evaluate the feasibility and efficacy of sildenafil citrate by comparing 2 groups of patients, the first without the drug and the second with 25 mg of sildenafil citrate.1) Feasibility and efficacy were assessed by comparing the amount of intraoperative bleeding, the effect of CVP, and the surgeon's operative field grading.2) Liver and renal function indexes, length of hospitalization, hospitalization costs, and postoperative complications were assessed by comparing patients' preoperative, 1d postoperative, 3d postoperative, and 7d postoperative occurrence, to assess the safety of its clinical application.
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First People's Hospital of Chenzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, zhiming zhang, First People's Hospital of Chenzhou
- Investigators
- Zhi-ming Z Zhang, Principal investigator, Chenzhou NO. 1 people's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06237751
- Sponsor's protocol ID
- 2023139
- Status last verified
- Jun 2024
- First submitted
- 3 Dec 2023
- Last updated
- 27 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen Q, Peng S, Zhou Y, Li S, Xu F, Yu Y, Wang P, Peng X, Zhao C, Xie A, Zhang Z. Perioperative sildenafil citrate administration in hepatectomy: a study protocol of randomized controlled trial. Trials. 2025 Jun 1;26(1):183. doi: 10.1186/s13063-025-08870-2.
PubMed 40450350
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Sildenafil Administration for Hepatectomy
- ClinicalTrials.gov ID
- NCT06237751
- Acronym / sponsor ID
- 2023139
- Keywords
- Sildenafil Citrate, Hepatectomy, Laparoscopy, Low central venous pressure, Study protocol
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- First People's Hospital of ChenzhouUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 1 Feb 2024 (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.
Hepatectomy is an important treatment for liver diseases, and bleeding is one of the most common complications during dissection of the liver parenchyma. The Control Low Central Venous Pressure (CLCVP) technique is currently one of the most important techniques to control intraoperative bleeding. It mainly consists of fluid restriction, position adjustment, and the use of vasodilators. However, these measures focus on decreasing CVP by reducing the volume of return blood, and less attention is paid to factors such as pulmonary vascular resistance and cardiac function. Sildenafil, known as Viagra, is currently used to treat erectile dysfunction and pulmonary hypertension in men. Its action inhibits phosphodiesterase-5 (PDE-5) and increases cGMP levels, leading to smooth muscle relaxation and vasodilation. Its pharmacological properties provide potential value for the treatment of many diseases. However, few studies have been conducted both domestically and internationally on the use of sildenafil citrate in liver resection related to CLCVP. This study aims to investigate the influence of preoperative oral administration of Sildenafil Citrate combined with IPM on IBL and surgical results during open or laparoscopic hepatectomy, as well as its safety and feasibility. It is expected to provide an innovative management optimization plan for reducing the bleeding in hepatectomy and to provide empirical support for the potential value of Sildenafil Citrate or Sildenafil-like drugs in improving the safety and quality of perioperative hepatectomy patients.
Detailed description
- Feasibility/Effectiveness evaluation indicators: Primary outcomes：
- Intraoperative blood loss: To quantify the IBL by calculating the amount of blood in the suction bottle (actual blood loss amount - saline irrigation amount) and the weight of the gauze blood pad ((weight of the gauze block after blood absorption in g - weight of the gauze block before blood absorption in g) / 1.054 (average density of blood in g/ml)).
- The classification of the surgical field: At T3 and T4, the surgeon will rate and score the liver surgical field according to Table 2. If the score is lower than 70 points, CLCVP technique will be initiated to improve the surgical conditions. At T5, the surgeon will re-evaluate the surgical field to assess the effectiveness of the CLCVP technique. At the same time, the surgeon will independently evaluate the performance of the anesthesiologist in controlling surgical field and ensuring the patient's safety, so as to comprehensively reflect the contribution of anesthesia management to the surgery. To ensure the objectivity of the assessment, the lead surgeon will remain blind to the patient group situation throughout the process. Secondary outcomes:
- Cumulative consumption of nitroglycerine: Based on the criterion of CLCVP, record whether the patient needs to use nitroglycerine during the operation and the dose used.
- Hemodynamic parameters: Collect data such as SBP, DBP, MAP, CVP, CO, SV, SVV, SVR, HR, SpO2 at the time when the patient enters the operating room (T0), after induction (T1), 15 minutes after adjusting the body position (T2), 30 minutes after the start of liver resection (T3), 60 minutes after the start of liver resection (T4), after liver resection (T5), and at the end of the operation (T6) to assess the influence of sildenafil on the intraoperative hemodynamic stability.
- Safety evaluation indicators:
- Blood gas analysis: Measure Hb, PH, and Lac at T1, T3, T4, and T5 to understand the patient's internal environment status.
- Coagulation function：Understand the changes in the coagulation function of the patient during the operation by measuring the TEG of the patient at T2 and T5, and measure the APTT and PT values at D1, D3, and D5 to understand whether there is an impact on the patient's postoperative coagulation function after taking Sildenafil.
- Intraoperative urine output: By recording the intraoperative urine output value of the patient at T6.
- Adverse events in the recovery room：It is evaluated by measuring whether the patient has hypotension and whether there is hypoxemia in the recovery room.
- Biochemical markers (Liver and kidney functions): It is evaluated by measuring the levels of TBil, Alb, AST, ALT, Cr, BUN of the patients on days -D1, D1, D3, and D5.
- Complete blood count: At -D1, D1, D3, and D5, it is evaluated by measuring the patient's postoperative Hb, Plt, and Hct.
- Cardiac function: By comparing the levels of BNP, CK-MB, and cTn of the patients on days D1 to assess whether Sildenafil has an impact on the patient's cardiac function.
- Postoperative hospital stay and drainage indwelling time: Record the patient's hospital stay and drainage tube placement time to assess the patient's recovery speed.
- Postoperative complications: Whether to enter the ICU after surgery, liver failure, bleeding, bile leakage, ascites, pleural effusion, and incision site infection.
- (- D1: The day before surgery; - T0: half an hour before surgery; T0: entering the operating room; T1: post induction; T2: 5 minutes after 30° head-up and foot-down position; T3: 30 minutes after the start of liver resection; T4: 60 minutes after the start of liver resection; T5: after liver resection; T6: at the end of the operation; D1: Postoperative day 1; D3: Postoperative day 3; D5: Postoperative day 5)
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The investigators planned a study to evaluate the feasibility and efficacy of sildenafil citrate by comparing 2 groups of patients, the first without the drug and the second with 25 mg of sildenafil citrate.1) Feasibility and efficacy were assessed by comparing the amount of intraoperative bleeding, the effect of CVP, and the surgeon's operative field grading.2) Liver and renal function indexes, length of hospitalization, hospitalization costs, and postoperative complications were assessed by comparing patients' preoperative, 1d postoperative, 3d postoperative, and 7d postoperative occurrence, to assess the safety of its clinical application.
| Arm | Type | Receives |
|---|---|---|
| calcium tablet | Other | Drug: Sildenafil 100 MGcalcium tablet |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients undergoing hepatic resection
- age from 18-85 years
- Child-Pugh ≤B
- ASA II-III
- willing to join the trial.
Key exclusion criteria (7 listed)
- Pregnancy or Lactation
- Known Allergy to any Medications used in the Study
- Hemoglobin (Hb) < 90 g/L
- Body Mass Index (BMI) > 35 kg/m2 or < 18 kg/m2
- Hypertension > 180 mmHg
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 |
|---|---|---|
| Sildenafil 100 MGAlso: nitroglycerineSildenafil 100mg orally half an hour before surgery | Drug | calcium tablet |
Primary outcome
Intraoperative blood loss
Time frame: At the end of the operation
To quantify the IBL by calculating the amount of blood in the suction bottle (actual blood loss amount - saline irrigation amount) and the weight of the gauze blood pad ((weight of the gauze block after blood absorption in g - weight of the gauze block before blood absorption in g) / 1.054 (average density of blood in g/ml)).
The classification of the surgical field
Time frame: At the end of the operation
At T3 and T4, the surgeon will rate and score the liver surgical field according to Table 2. If the score is lower than 70 points, CLCVP technique will be initiated to improve the surgical conditions. At T5, the surgeon will re-evaluate the surgical field to assess the effectiveness of the CLCVP technique. At the same time, the surgeon will independently evaluate the performance of the anesthesiologist in controlling surgical field and ensuring the patient's safety, so as to comprehensively reflect the contribution of anesthesia management to the surgery. To ensure the objectivity of the assessment, the lead surgeon will remain blind to the patient group situation throughout the process.(At 30 minutes after the start of liver resection(T3), 60 minutes after the start of liver resection(T4) and after liver resection(T5))
12 secondary outcomes
Cumulative consumption of nitroglycerine
Time frame: At the end of the operation
Hemodynamic parameters
Time frame: At the end of the operation
Blood gas analysis
Time frame: At the end of the operation
Intraoperative urine output
Time frame: At the end of the operation(T6)
Adverse events in the recovery room
Time frame: After the end of surgery, Patient in recovery room.
Liver function
Time frame: At the day before surgery(-D1), postoperative day 1(D1), postoperative day 3(D3) and postoperative day 5(D5).
kidney function
Time frame: At the day before surgery(-D1), postoperative day 1(D1), postoperative day 3(D3) and postoperative day 5(D5).
Complete blood count
Time frame: At the day before surgery(-D1), postoperative day 1(D1), postoperative day 3(D3) and postoperative day 5(D5).
Cardiac function
Time frame: At Postoperative day 1
Postoperative hospital stay
Time frame: At Postoperative day 5
Drainage indwelling time
Time frame: At Postoperative day 5
Postoperative complications
Time frame: At postoperative day 1, postoperative day 3 and postoperative day 5
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
- Derived from this study: PubMed 40450350Chen Q, Peng S, Zhou Y, Li S, Xu F, Yu Y, Wang P, Peng X, Zhao C, Xie A, Zhang Z. Perioperative sildenafil citrate administration in hepatectomy: a study protocol of randomized controlled trial. Trials. 2025 Jun 1;26(1):183. doi: 10.1186/s13063-025-08870-2.
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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.
Zhi-ming Z Zhang principal investigator
Chenzhou NO. 1 people's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sildenafil 100 MG in people with Central Venous Pressure and Hepatectomy, run by First People's Hospital of Chenzhou 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 5 inclusion and 7 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 27 Jun 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qisheng Z Chen (+8618711451175, cqs19990715@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative blood loss (time frame: At the end of the operation). The study lists 2 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 NCT06237751, which also lists 1 linked publication.
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 27 Jun 2024.