Blood Loss, SurgicalNCT03379103
Bleeding in Knee Arthroplasty After Preconditioning With Sevoflurane
A study testing Sevoflurane and Propofol in people with Blood Loss, Surgical and Blood Transfusion, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
Knee arthroplasty is performed with restriction of blood flow by use of the pressure tourniquet. Ischemia of skeletal musculature is accompanied by the formation of reactive oxygen species and release of vasoactive factors. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Loss, Surgical, Blood Transfusion
- What is being tested?
- Sevoflurane and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Feb 2018to 19 Dec 2020
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- indication for knee arthroplasty
Who cannot join
- Physical state according to classification from American Association of Anesthesiologists (ASA) III or higher,
- Obesity (body mass index, BMI, greater than 30),
- Renal insufficiency - patients on a dialysis program or with a serum creatinine level above 1.4 mg / dL,
- Hematocrit less than 30% or hemoglobin less than 10g / dL,
- Records of myocardial infarction during the last 6 months, unstable angina pectoris,
- History of coagulation disorders,
- Use of oral anticoagulants, heparin or acetylsalicylic acid in the last 5 days.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das Clínicas - Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, 01246-903
About this study
Official title: Effects on Bleeding in Knee Arthroplasty After Ischemic Preconditioning With Sevoflurane
Knee arthroplasty is performed with restriction of blood flow by use of the pressure tourniquet. Ischemia of skeletal musculature is accompanied by the formation of reactive oxygen species and release of vasoactive factors. Inhaled anesthetics were described as possible protective factors, termed "ischemic preconditioning". The objective of this investigation is to observe the effects of preconditioning with inhaled anesthetic on bleeding in the postoperative period of knee arthroplasty surgery. The study will be prospective and randomized. Patients will be allocated by means of a randomized table in two groups: Group Preconditioning (GP) - subarachnoid and general anesthesia with preconditioning with 1 minimal alveolar concentration (MAC) for 15 minutes before the installation of the ischemia by tourniquet; Group control (GC) - subarachnoid and general anesthesia with sevoflurane without preconditioning. Will be evaluated: hemoglobin and hematocrit, platelet count and coagulogram, electrolytes and creatinine, lactate and glycemia. Volume of drainage will be evaluated until drainage is withdrawn and need for transfusion measuring the number of bags of blood concentrate and volume transfused. Pain assessment will be done by means of visual analog scale. Morbidity will be recorded up to the 30th postoperative day by chart analysis. Patients will be allocated to the study groups by random number table. Data will be presented descriptively, frequently, mean and standard deviation, or medians and distribution in 25-75% percentiles. The comparison between continuous measurements will be made by means of repeated measures intra-group analysis of variance (ANOVA) and Student's t-test for evaluation between groups. The need for transfusion will be compared by Fisher's exact test. Pain intensity will be compared by Wilcoxon test for non-parametric data. A commercially available statistical package - SPSS version 15.0 (SPSS Inc.) will be used. A value of P <0.05 will be considered statistically significant.
Read the detailed description
The use of pneumatic tourniquet allows a clear surgical field by restricting blood flow to the area to be operated, which implies at least intraoperative bleeding, but with a high risk of postoperative bleeding.
The late bleeding associated with tourniquet use appears to be due to the imbalance between coagulation and fibrinolysis. The use of antifibrinolytics, such as tranexamic acid and epsilon aminocaproic acid, has been shown to reduce postoperative bleeding, reducing the need for transfusion of blood components postoperatively, without increasing the risk of thromboembolism. The effects of tourniquet, which can be maintained at intervals of 75 to 100 minutes, include elevation in blood pressure while it is insuflated, cardiac index elevation during ischemia and its subsequent elevation at the moment of release to the circulation, at which time there is also an increase in oxygen consumption as well as the release of CO2. This increase in oxygen consumption is directly related to the time of ischemia.
Skeletal muscles's ischemia is accompanied by anaerobic glycolysis, formation of reactive oxygen species, and release of vasoactive factors. Inhaled anesthetics, such as isoflurane and sevoflurane, have been described as possible protective factors for both cardiac and skeletal muscles, although the literature still suggests the need for additional studies. Its use in the period before the onset of ischemia is called "ischemic preconditioning".
The objective of this investigation will be to observe the effects of an inhalational anesthetic, commonly used in anesthesia on bleeding, in the results of coagulation tests and in the consumption of blood components in the postoperative period of knee arthroplasty surgery.
Goals
To compare the effects of preconditioning with sevoflurane in total knee arthroplasty surgery by:
- Coagulogram for coagulation times;
- Volume of blood drainage in the postoperative period;
- Need and volume of blood transfusion;
- Dosage of arterial pH, lactate and CPK enzyme;
- Immediate postoperative morbidity and up to 30 days postoperatively.
Statistic
Data will be presented by descriptive tables and frequency, mean and standard deviation, or medians and distribution in 25-75% percentiles for data that do not find a normal distribution. The Kolmogorov-Smirnov test will determine if there is a normal distribution.
Values for hemoglobin, hematocrit, platelet count, arterial blood gas values, electrolytes, creatinine, CPK, lactate, blood glucose and coagulogram will be compared by analysis of variance (ANOVA).
The intragroup analyzes will use repeated measures ANOVA and the Dunnett test if there is a significant difference between the moments of the same group, since the test may be better considered for comparison with a control (preoperative) time. Between the groups, the values will be compared moment by moment with Student's t-test.
The need for transfusion, considering the number of CC bags, will be compared by Fisher's exact test and its volume by Student's t-test. Pain intensity in the postoperative period will be evaluated by visual analogue scale and compared by Wilcoxon's test for non-parametric data between the time of entry and discharge of RPA. A commercially available statistical package - SPSS version 15.0 (SPSS Inc.) will be used. A value of P <0.05 will be considered statistically significant.
Patients will be allocated to the study groups by random number table. Briefly, generating a list of two-digit numbers determines the order of entry of patients into the study groups. A minimum expected difference between the means of the treatments (groups) established at 500 ml for the required volume of postoperative transfusion, standard deviation at 400 ml, with test power at 80% and significance level in 5% suggesting a distribution of 15 patients in each group, considering losses in 50%.
- Conditions
- Blood Loss, Surgical, Blood Transfusion
- Being tested
- Sevoflurane, Propofol
- Keywords
- Blood Loss, Surgical, Blood Transfusion, Arthroplasty, Replacement, Knee, anesthetic preconditioning
- Medical subject headings
- Blood Loss, Surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
Patients will receive 1 MAC sevoflurane for 15 minutes before the installation of member ischemia by tourniquete
PropofolDrug
Patients will receive propofol for 15 minutes before the installation of member ischemia by tourniquete
| Study group | Role | What they receive |
|---|---|---|
| GP - sevoflurane | Active comparator | GP - patients will be anesthetized with sevoflurane associated with subarachnoid anesthesia and will be preconditioned with 1 MAC sevoflurane for 15 minutes before the installation of ischemia by tourniquete Receives: Drug: Sevoflurane |
| GC - control | Placebo comparator | GC - patients will be anesthetized with sevoflurane associated with subarachnoid anesthesia and will be preconditioned with intravenous propofol for 15 minutes before the installation of ischemia by tourniquete. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood loss
Volume of blood drainage in the postoperative period;
Measured: 24 hours
Secondary outcomes (2)
Blood transfusion
Need and volume of blood transfusion;
Measured: 24 hours
Morbidity
Immediate postoperative morbidity and up to 30 days postoperatively.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2017
- Study start2 Feb 2018
- Primary completion19 Dec 2018
- Study completion19 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Blood Loss, SurgicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be allocated by means of a randomized table in 2 groups: GP - patients will be anesthetized with sevoflurane associated with subarachnoid anesthesia and will be preconditioned with 1 MAC sevoflurane for 15 minutes before the installation of ischemia by tourniquete GC - patients will be anesthetized with sevoflurane associated with subarachnoid anesthesia
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joaquim Edson Vieira, University of Sao Paulo General Hospital
- Investigators
- Joaquim E Vieira, MD, PhD, Principal investigator, University of Sao Paulo School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03379103
- Sponsor's protocol ID
- CAAE 03735612.7.0000.0068
- Status last verified
- Feb 2021
- First submitted
- 14 Dec 2017
- Last updated
- 25 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Burkart BC, Bourne RB, Rorabeck CH, Kirk PG, Nott L. The efficacy of tourniquet release in blood conservation after total knee arthroplasty. Clin Orthop Relat Res. 1994 Feb;(299):147-52.
PubMed 8119009Cid J, Lozano M. Tranexamic acid reduces allogeneic red cell transfusions in patients undergoing total knee arthroplasty: results of a meta-analysis of randomized controlled trials. Transfusion. 2005 Aug;45(8):1302-7. doi: 10.1111/j.1537-2995.2005.00204.x.
PubMed 16078916Kagoma YK, Crowther MA, Douketis J, Bhandari M, Eikelboom J, Lim W. Use of antifibrinolytic therapy to reduce transfusion in patients undergoing orthopedic surgery: a systematic review of randomized trials. Thromb Res. 2009 Mar;123(5):687-96. doi: 10.1016/j.thromres.2008.09.015. Epub 2008 Nov 12.
PubMed 19007970Yang ZG, Chen WP, Wu LD. Effectiveness and safety of tranexamic acid in reducing blood loss in total knee arthroplasty: a meta-analysis. J Bone Joint Surg Am. 2012 Jul 3;94(13):1153-9. doi: 10.2106/JBJS.K.00873.
PubMed 22623147Girardis M, Milesi S, Donato S, Raffaelli M, Spasiano A, Antonutto G, Pasqualucci A, Pasetto A. The hemodynamic and metabolic effects of tourniquet application during knee surgery. Anesth Analg. 2000 Sep;91(3):727-31. doi: 10.1097/00000539-200009000-00043.
PubMed 10960408Carles M, Dellamonica J, Roux J, Lena D, Levraut J, Pittet JF, Boileau P, Raucoules-Aime M. Sevoflurane but not propofol increases interstitial glycolysis metabolites availability during tourniquet-induced ischaemia-reperfusion. Br J Anaesth. 2008 Jan;100(1):29-35. doi: 10.1093/bja/aem321. Epub 2007 Nov 20.
PubMed 18029344Kersten JR, Schmeling TJ, Pagel PS, Gross GJ, Warltier DC. Isoflurane mimics ischemic preconditioning via activation of K(ATP) channels: reduction of myocardial infarct size with an acute memory phase. Anesthesiology. 1997 Aug;87(2):361-70. doi: 10.1097/00000542-199708000-00024.
PubMed 9286901Cram P, Vaughan-Sarrazin MS, Wolf B, Katz JN, Rosenthal GE. A comparison of total hip and knee replacement in specialty and general hospitals. J Bone Joint Surg Am. 2007 Aug;89(8):1675-84. doi: 10.2106/JBJS.F.00873.
PubMed 17671004Holte K, Kristensen BB, Valentiner L, Foss NB, Husted H, Kehlet H. Liberal versus restrictive fluid management in knee arthroplasty: a randomized, double-blind study. Anesth Analg. 2007 Aug;105(2):465-74. doi: 10.1213/01.ane.0000263268.08222.19.
PubMed 17646507Brookenthal KR, Freedman KB, Lotke PA, Fitzgerald RH, Lonner JH. A meta-analysis of thromboembolic prophylaxis in total knee arthroplasty. J Arthroplasty. 2001 Apr;16(3):293-300. doi: 10.1054/arth.2001.21499.
PubMed 11307125Whitley E, Ball J. Statistics review 4: sample size calculations. Crit Care. 2002 Aug;6(4):335-41. doi: 10.1186/cc1521. Epub 2002 May 10.
PubMed 12225610
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects on Bleeding in Knee Arthroplasty After Ischemic Preconditioning With Sevoflurane
- ClinicalTrials.gov ID
- NCT03379103
- Acronym / sponsor ID
- CAAE 03735612.7.0000.0068
- Conditions
- Blood Loss, Surgical, Blood Transfusion
- Keywords
- Blood Loss, Surgical, Blood Transfusion, Arthroplasty, Replacement, Knee, anesthetic preconditioning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 2 Feb 2018 (actual)
- Primary completion
- 19 Dec 2018 (actual)
- Study completion
- 19 Dec 2020 (actual)
- First posted
- 20 Dec 2017 (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.
Knee arthroplasty is performed with restriction of blood flow by use of the pressure tourniquet. Ischemia of skeletal musculature is accompanied by the formation of reactive oxygen species and release of vasoactive factors. Inhaled anesthetics were described as possible protective factors, termed "ischemic preconditioning". The objective of this investigation is to observe the effects of preconditioning with inhaled anesthetic on bleeding in the postoperative period of knee arthroplasty surgery. The study will be prospective and randomized. Patients will be allocated by means of a randomized table in two groups: Group Preconditioning (GP) - subarachnoid and general anesthesia with preconditioning with 1 minimal alveolar concentration (MAC) for 15 minutes before the installation of the ischemia by tourniquet; Group control (GC) - subarachnoid and general anesthesia with sevoflurane without preconditioning. Will be evaluated: hemoglobin and hematocrit, platelet count and coagulogram, electrolytes and creatinine, lactate and glycemia. Volume of drainage will be evaluated until drainage is withdrawn and need for transfusion measuring the number of bags of blood concentrate and volume transfused. Pain assessment will be done by means of visual analog scale. Morbidity will be recorded up to the 30th postoperative day by chart analysis. Patients will be allocated to the study groups by random number table. Data will be presented descriptively, frequently, mean and standard deviation, or medians and distribution in 25-75% percentiles. The comparison between continuous measurements will be made by means of repeated measures intra-group analysis of variance (ANOVA) and Student's t-test for evaluation between groups. The need for transfusion will be compared by Fisher's exact test. Pain intensity will be compared by Wilcoxon test for non-parametric data. A commercially available statistical package - SPSS version 15.0 (SPSS Inc.) will be used. A value of P <0.05 will be considered statistically significant.
Detailed description
The use of pneumatic tourniquet allows a clear surgical field by restricting blood flow to the area to be operated, which implies at least intraoperative bleeding, but with a high risk of postoperative bleeding.
The late bleeding associated with tourniquet use appears to be due to the imbalance between coagulation and fibrinolysis. The use of antifibrinolytics, such as tranexamic acid and epsilon aminocaproic acid, has been shown to reduce postoperative bleeding, reducing the need for transfusion of blood components postoperatively, without increasing the risk of thromboembolism. The effects of tourniquet, which can be maintained at intervals of 75 to 100 minutes, include elevation in blood pressure while it is insuflated, cardiac index elevation during ischemia and its subsequent elevation at the moment of release to the circulation, at which time there is also an increase in oxygen consumption as well as the release of CO2. This increase in oxygen consumption is directly related to the time of ischemia.
Skeletal muscles's ischemia is accompanied by anaerobic glycolysis, formation of reactive oxygen species, and release of vasoactive factors. Inhaled anesthetics, such as isoflurane and sevoflurane, have been described as possible protective factors for both cardiac and skeletal muscles, although the literature still suggests the need for additional studies. Its use in the period before the onset of ischemia is called "ischemic preconditioning".
The objective of this investigation will be to observe the effects of an inhalational anesthetic, commonly used in anesthesia on bleeding, in the results of coagulation tests and in the consumption of blood components in the postoperative period of knee arthroplasty surgery.
Goals
To compare the effects of preconditioning with sevoflurane in total knee arthroplasty surgery by:
- Coagulogram for coagulation times;
- Volume of blood drainage in the postoperative period;
- Need and volume of blood transfusion;
- Dosage of arterial pH, lactate and CPK enzyme;
- Immediate postoperative morbidity and up to 30 days postoperatively.
Statistic
Data will be presented by descriptive tables and frequency, mean and standard deviation, or medians and distribution in 25-75% percentiles for data that do not find a normal distribution. The Kolmogorov-Smirnov test will determine if there is a normal distribution.
Values for hemoglobin, hematocrit, platelet count, arterial blood gas values, electrolytes, creatinine, CPK, lactate, blood glucose and coagulogram will be compared by analysis of variance (ANOVA).
The intragroup analyzes will use repeated measures ANOVA and the Dunnett test if there is a significant difference between the moments of the same group, since the test may be better considered for comparison with a control (preoperative) time. Between the groups, the values will be compared moment by moment with Student's t-test.
The need for transfusion, considering the number of CC bags, will be compared by Fisher's exact test and its volume by Student's t-test. Pain intensity in the postoperative period will be evaluated by visual analogue scale and compared by Wilcoxon's test for non-parametric data between the time of entry and discharge of RPA. A commercially available statistical package - SPSS version 15.0 (SPSS Inc.) will be used. A value of P <0.05 will be considered statistically significant.
Patients will be allocated to the study groups by random number table. Briefly, generating a list of two-digit numbers determines the order of entry of patients into the study groups. A minimum expected difference between the means of the treatments (groups) established at 500 ml for the required volume of postoperative transfusion, standard deviation at 400 ml, with test power at 80% and significance level in 5% suggesting a distribution of 15 patients in each group, considering losses in 50%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be allocated by means of a randomized table in 2 groups: GP - patients will be anesthetized with sevoflurane associated with subarachnoid anesthesia and will be preconditioned with 1 MAC sevoflurane for 15 minutes before the installation of ischemia by tourniquete GC - patients will be anesthetized with sevoflurane associated with subarachnoid anesthesia
| Arm | Type | Receives |
|---|---|---|
| GP - sevoflurane | Active comparator | Drug: SevofluraneGP - patients will be anesthetized with sevoflurane associated with subarachnoid anesthesia and will be preconditioned with 1 MAC sevoflurane for 15 minutes before the installation of ischemia by tourniquete |
| GC - control | Placebo comparator | Drug: PropofolGC - patients will be anesthetized with sevoflurane associated with subarachnoid anesthesia and will be preconditioned with intravenous propofol for 15 minutes before the installation of ischemia by tourniquete. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- indication for knee arthroplasty
Key exclusion criteria (7 listed)
- Physical state according to classification from American Association of Anesthesiologists (ASA) III or higher,
- Obesity (body mass index, BMI, greater than 30),
- Renal insufficiency - patients on a dialysis program or with a serum creatinine level above 1.4 mg / dL,
- Hematocrit less than 30% or hemoglobin less than 10g / dL,
- Records of myocardial infarction during the last 6 months, unstable angina pectoris,
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 |
|---|---|---|
| SevofluranePatients will receive 1 MAC sevoflurane for 15 minutes before the installation of member ischemia by tourniquete | Drug | GP - sevoflurane |
| PropofolPatients will receive propofol for 15 minutes before the installation of member ischemia by tourniquete | Drug | GC - control |
Primary outcome
Blood loss
Time frame: 24 hours
Volume of blood drainage in the postoperative period;
2 secondary outcomes
Blood transfusion
Time frame: 24 hours
Morbidity
Time frame: 30 days
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 25 Feb 2021.
- Results publication: PubMed 8119009Burkart BC, Bourne RB, Rorabeck CH, Kirk PG, Nott L. The efficacy of tourniquet release in blood conservation after total knee arthroplasty. Clin Orthop Relat Res. 1994 Feb;(299):147-52.
- Results publication: PubMed 16078916Cid J, Lozano M. Tranexamic acid reduces allogeneic red cell transfusions in patients undergoing total knee arthroplasty: results of a meta-analysis of randomized controlled trials. Transfusion. 2005 Aug;45(8):1302-7. doi: 10.1111/j.1537-2995.2005.00204.x.
- Results publication: PubMed 19007970Kagoma YK, Crowther MA, Douketis J, Bhandari M, Eikelboom J, Lim W. Use of antifibrinolytic therapy to reduce transfusion in patients undergoing orthopedic surgery: a systematic review of randomized trials. Thromb Res. 2009 Mar;123(5):687-96. doi: 10.1016/j.thromres.2008.09.015. Epub 2008 Nov 12.
- Results publication: PubMed 22623147Yang ZG, Chen WP, Wu LD. Effectiveness and safety of tranexamic acid in reducing blood loss in total knee arthroplasty: a meta-analysis. J Bone Joint Surg Am. 2012 Jul 3;94(13):1153-9. doi: 10.2106/JBJS.K.00873.
- Results publication: PubMed 10960408Girardis M, Milesi S, Donato S, Raffaelli M, Spasiano A, Antonutto G, Pasqualucci A, Pasetto A. The hemodynamic and metabolic effects of tourniquet application during knee surgery. Anesth Analg. 2000 Sep;91(3):727-31. doi: 10.1097/00000539-200009000-00043.
- Results publication: PubMed 18029344Carles M, Dellamonica J, Roux J, Lena D, Levraut J, Pittet JF, Boileau P, Raucoules-Aime M. Sevoflurane but not propofol increases interstitial glycolysis metabolites availability during tourniquet-induced ischaemia-reperfusion. Br J Anaesth. 2008 Jan;100(1):29-35. doi: 10.1093/bja/aem321. Epub 2007 Nov 20.
- Results publication: PubMed 9286901Kersten JR, Schmeling TJ, Pagel PS, Gross GJ, Warltier DC. Isoflurane mimics ischemic preconditioning via activation of K(ATP) channels: reduction of myocardial infarct size with an acute memory phase. Anesthesiology. 1997 Aug;87(2):361-70. doi: 10.1097/00000542-199708000-00024.
- Results publication: PubMed 17671004Cram P, Vaughan-Sarrazin MS, Wolf B, Katz JN, Rosenthal GE. A comparison of total hip and knee replacement in specialty and general hospitals. J Bone Joint Surg Am. 2007 Aug;89(8):1675-84. doi: 10.2106/JBJS.F.00873.
- Results publication: PubMed 17646507Holte K, Kristensen BB, Valentiner L, Foss NB, Husted H, Kehlet H. Liberal versus restrictive fluid management in knee arthroplasty: a randomized, double-blind study. Anesth Analg. 2007 Aug;105(2):465-74. doi: 10.1213/01.ane.0000263268.08222.19.
- Results publication: PubMed 11307125Brookenthal KR, Freedman KB, Lotke PA, Fitzgerald RH, Lonner JH. A meta-analysis of thromboembolic prophylaxis in total knee arthroplasty. J Arthroplasty. 2001 Apr;16(3):293-300. doi: 10.1054/arth.2001.21499.
- Results publication: PubMed 12225610Whitley E, Ball J. Statistics review 4: sample size calculations. Crit Care. 2002 Aug;6(4):335-41. doi: 10.1186/cc1521. Epub 2002 May 10.
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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.
Joaquim E Vieira, MD, PhD principal investigator
University of Sao Paulo School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sevoflurane and Propofol in people with Blood Loss, Surgical and Blood Transfusion, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 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: finished, as of the sponsor's last update on 25 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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. Some participants in this study may receive a placebo. 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?
Blood loss (time frame: 24 hours). 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 NCT03379103, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2021.