Point-of-care Management of Coagulopathy in Lung Transplantation
NCT ID: NCT03598907
Last Updated: 2025-06-10
Study Results
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View full resultsBasic Information
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Recruitment Status
TERMINATED
Total Enrollment
100 participants
Study Classification
OBSERVATIONAL
Study Start Date
2018-01-01
Study Completion Date
2020-06-30
Brief Summary
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Pulmonary transplantation is a very demanding surgical procedure, often accompanied by coagulopathy and severe perioperative bleeding. The most common complication that develops within the first 72 hours after surgery is primary graft dysfunction (PGD), up to 30% in the most severe form. The etiology of PGD is multifactorial. One of the causes may be the amount of perioperative blood loss. Intravascular volume is normally maintained by the administration of crystalloid and colloid solutions and fresh frozen plasma, which is also used to treat coagulopathy, however it is administered at the discretion of the anaesthetist and his experience, practically meaning ,,blindly". In the field of the allogeneous ischemic organ, these substitution solutions essentially become another allogeneous material and can cause undesired immunomodulation and contribute to the development of PGD. In our prospective randomized trial (120 patients), two patient groups will be investigated. In the first group, the coagulopathy and perioperative blood loss will be treated by the current standard approach, by ,,blind" administration of fresh frozen plasma, crystalloids and colloids. In the second group, the cause of coagulopathy will be diagnosed and treated according to the point-of-care (POC) results of ROTEM, PFA 200 and Multiplate. A colloidal solution of 5% albumin will be used to replace the circulating volume and maintain the oncotic pressure. Investigators assume that the POC management of coagulopathy and bleeding in the second group will lead to a reduction in perioperative bleeding, to reduced administration of infusion solutions, and thus to a reduction of the incidence of PGD.
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Detailed Description
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Introduction and project description:
Primary graft dysfunction (PGD) in lung transplant patients is described as acute pulmonary damage occurring early in lung transplantation (in the first 72 hours) (1, 2), sometimes referred to as ischemia - reperfusion injury (1). It is characterized by non-cardiac pulmonary edema and diffuse alveolar damage. Clinically, it is manifested by varying degrees of hypoxemia, along with diffuse infiltrates in the X-ray of the lung. There are more theories that try to explain the cause of PGD. A number of factors such as cold organ ischemia, mechanical irritation during organ reperfusion, immunological, inflammatory, microbiological factors, and many others associated with lung transplantation (2, 3) may play a roll. Depending on the severity of the clinical symptoms and the severity of X-ray findings according to International Society of Heart and Lung Transplantation (ISHLT) there are three types of PGD. The incidence of PGD in its worst form (Grade 3) in early post-transplantation period is being reported to be present in up to 30% and between 10-25% within 24-72 hours after organ reperfusion. Lighter forms of PGD (1st and 2nd degree) occur much more frequently (2,3). Lung affected by PGD is characteristically edematous and the gas exchange is significantly impaired due to damage to the endothelial barrier integrity of the vessels and the epithelial barrier of the lung tissue. The presence of PGD significantly increases the morbidity and mortality of patients and significantly prolongs the time spent in invasive mechanical ventilation, generally prolongs the time spent in intensive care unit and is a significant risk factor for development of chronic rejection of the transplanted lung (2,3).
Lung transplantation is a demanding surgical procedure often associated with the development of coagulopathy and significant bleeding, especially when extracorporeal membrane oxygenation (ECMO) is used perioperatively, which is practically used in the most cases. Blood loss is replaced by the administration of crystalloid and colloid solutions in order to maintain normovolemia and by administering FFP, which is also used to treat coagulopathy, despite the fact that the International Normalized Ratio (INR) of blood plasma is 1.5-1.6. These preparations are administered according to the anesthesiologist's experience and practically ,,blindly". However, their administration in patient significantly immunocompromised may mean a risk of immunomodulation and thus a deterioration of PGD. In addition, the administration of blood plasma is generally associated with higher morbidity and mortality of patients (1).
On the other hand, point-of-care (POC) monitoring of the hemocoagulation state using rotational thromboelastometry (ROTEM) and subsequent targeted coagulopathy therapy during the perioperative period and traumatic life threatening bleeding resulted in decreased bleeding intensity and consumption of transfusion products and this approach led to a reduction in morbidity and mortality of these patients (2,3).
Also, methods for evaluating primary haemostasis such as PFA 200 (platelet function analyzer) and aggregometry-Multiplate can be used as POC methods in the operating room, especially for the diagnosis of coagulopathy accompanying the use of ECMO, especially for the diagnosis of von Willebrand's disease (PFA 200) or for the diagnosis of thrombocytopathy (Multiplate) (1-4).
All methods ROTEM, PFA 200 and Multiplate are used to predict bleeding in cardiac surgery and hepatic transplantation, and targeted therapy based on their results is associated with a reduction in blood transfusion (FFP, platelets, erythrocytes) administration, reduced bleeding and reduced morbidity and mortality (5-7).
Therefore, it can reasonably be assumed that a similar positive benefit of this POC approach can be expected even in patients undergoing lung transplantation.
In this prospective controlled randomized study of 120 lung transplant patients, investigators want to compare the incidence of PGD between a group of patients treated by standard ,,blind" approach and a ,,new" POC approach. Investigators assume that in a group where diagnosis and therapy of coagulopathy and bleeding will be managed based on the results of the ROTEM, PFA 200 and Multiplate tests, the clot strength will be increased and this will lead to reduced perioperative blood loss, reduced administration of infusion solutions and FFP and this will subsequently lead to reduced incidence of PGD.
Hypothesis:
Point-of-care approach to diagnosis of perioperative coagulopathy with ROTEM, PFA 200 and Multiplate and its subsequent aimed therapy will improve blood clot and thus will reduce blood loss, fluid infusion, blood transfusion and subsequently the incidence of PGD.
Methodology:
Patients undergoing bilateral lung transplantation (120 patients) will be randomized into 2 groups using computerised generator of random numbers. The study protocol will be registered in the Clinical Research Database and a clinical trial number (CTN) will be obtained and written informed consent will be obtained from patients before lung transplantation.
The first group of existing ,,standard care" - the approach to bleeding patient will be based on clinical experience of the anaesthetist, practically meaning administering crystalloids, colloids (hydroxyethyl starch or gelatin), fresh frozen plasma and erythrocytes to restore normovolemia and platelets, fibrinogen, prothrombin complex concentrate, von Willebrand factor, tranexamic acid, all products giving ,,blindly" when it comes to diagnosis and treatment of coagulopathy.
The second group of ,,point-of-care" approach to the diagnosis and treatment of perioperative bleeding and coagulopathy will be conducted on the basis of the results of the POC methods ROTEM, PFA 200 and Multiplate (prothrombin complex concentrate, fibrinogen, platelets, von Willebrand factor, tranexamic acid). A solution of 5% albumin and erythrocytes (to keep haemoglobin level over 100 g/l as it is critical for normal primary haemostasis) will be used to keep normal circulating volume and to compensate for perioperative blood loss.
Blood samples will obtained and analysed by ROTEM, PFA 200 and Multiplate, as well as the level and function of von Willebrand factor (multimers assay, ristocetin cofactor and collagen binding assay) will be performed in all patients:
1. before lung transplantation, upon patient arrival to hospital before surgery (as a control)
2. after lung transplantation, during admission of patient to postoperative intensive care unit
3. in the ,,POC" group also in the operating room (ROTEM, Multiplate and PFA 200) during surgery
The PGD score will be evaluated post-operatively and in the following way: severity of PGD is defined in four degrees and is evaluated using partial arterial oxygen pressure (PaO2) and inspired fraction of oxygen ratio (FiO2) ratio and simultaneously evaluating X-ray finding of the lungs as soon as possible after reperfusion (time 0) and after 48 and 72 hours after lung reperfusion.
* Grade 0 - PaO2/FiO2 ratio of any value but no pulmonary edema on chest X-ray
* Grade 1 - PaO2/FiO2 \> 300 and presence of pulmonary edema on chest X-ray
* Grade 2 - PaO2/FiO2 200 - 300 and and presence of pulmonary edema on chest X-ray
* Grade 3 - PaO2/FiO2 \< 200 and presence of pulmonary edema on chest X-ray or patients in need of postoperative ECMO support or nitric oxide therapy
To exclude the possible thrombotic complication of any of these approaches, each patient will be screened ultrasonographically for venous thrombosis 72 hours postoperatively (vena poplitea, vena femoralis, vena jugularis, and vena subclavia bilat) and thrombotic complications will compared between groups.
Also other parameters will be compared between groups:
* clot strength and whole coagulation profile before and after surgery using ROTEM, PFA 200 and Multiplate and evaluation of the functional level of von Willebrand factor. Correlation of coagulation profile with blood loss in the operating room and postoperative blood loss will be also assessed.
* amount of perioperative blood loss in the operating room at the end of surgery and 24 hours after surgery (blood loss will measured as amount of blood in the suction container in operating room and as amount of blood in the chest drain in ICU postoperatively)
* number of transfusion products administered in operating room and in postoperative ICU
* duration of invasive and noninvasive mechanical ventilation and time to extubation (hours), duration of stay in the postoperative ICU and overall in hospital before discharge home (days)
* morbidity of patients (SOFA score at 24, 48 and 72 hours after lung transplantation), morbidity and mortality among patients in 30, 90 and 365 days
* incidence of lung graft rejection during whole period of hospitalisation
Time schedule: 4 years During the 3-years period recruitment of patients will be done and in the 4-th year data will be analysed and published in valuable journals.
Investigators expect a lower consumption of blood transfusion products and infusion solutions in the POC group.
In case of lower PGD incidence in the POC group investigators expect shorter time of mechanical ventilation, a shorter period of hospitalization at the postoperative ICU and in the hospital overall and a lower incidence of pulmonary graft rejection.
Investigators expect lower morbidity and mortality of patients in the POC group.
Investigators also believe that the POC approach will reduce the total hospitalisation costs.
Primary graft dysfunction (PGD) in lung transplant patients is described as acute pulmonary damage occurring early in lung transplantation (in the first 72 hours) (1, 2), sometimes referred to as ischemia - reperfusion injury (1). It is characterized by non-cardiac pulmonary edema and diffuse alveolar damage. Clinically, it is manifested by varying degrees of hypoxemia, along with diffuse infiltrates in the X-ray of the lung. There are more theories that try to explain the cause of PGD. A number of factors such as cold organ ischemia, mechanical irritation during organ reperfusion, immunological, inflammatory, microbiological factors, and many others associated with lung transplantation (2, 3) may play a roll. Depending on the severity of the clinical symptoms and the severity of X-ray findings according to International Society of Heart and Lung Transplantation (ISHLT) there are three types of PGD. The incidence of PGD in its worst form (Grade 3) in early post-transplantation period is being reported to be present in up to 30% and between 10-25% within 24-72 hours after organ reperfusion. Lighter forms of PGD (1st and 2nd degree) occur much more frequently (2,3). Lung affected by PGD is characteristically edematous and the gas exchange is significantly impaired due to damage to the endothelial barrier integrity of the vessels and the epithelial barrier of the lung tissue. The presence of PGD significantly increases the morbidity and mortality of patients and significantly prolongs the time spent in invasive mechanical ventilation, generally prolongs the time spent in intensive care unit and is a significant risk factor for development of chronic rejection of the transplanted lung (2,3).
Lung transplantation is a demanding surgical procedure often associated with the development of coagulopathy and significant bleeding, especially when extracorporeal membrane oxygenation (ECMO) is used perioperatively, which is practically used in the most cases. Blood loss is replaced by the administration of crystalloid and colloid solutions in order to maintain normovolemia and by administering FFP, which is also used to treat coagulopathy, despite the fact that the International Normalized Ratio (INR) of blood plasma is 1.5-1.6. These preparations are administered according to the anesthesiologist's experience and practically ,,blindly". However, their administration in patient significantly immunocompromised may mean a risk of immunomodulation and thus a deterioration of PGD. In addition, the administration of blood plasma is generally associated with higher morbidity and mortality of patients (1).
On the other hand, point-of-care (POC) monitoring of the hemocoagulation state using rotational thromboelastometry (ROTEM) and subsequent targeted coagulopathy therapy during the perioperative period and traumatic life threatening bleeding resulted in decreased bleeding intensity and consumption of transfusion products and this approach led to a reduction in morbidity and mortality of these patients (2,3).
Also, methods for evaluating primary haemostasis such as PFA 200 (platelet function analyzer) and aggregometry-Multiplate can be used as POC methods in the operating room, especially for the diagnosis of coagulopathy accompanying the use of ECMO, especially for the diagnosis of von Willebrand's disease (PFA 200) or for the diagnosis of thrombocytopathy (Multiplate) (1-4).
All methods ROTEM, PFA 200 and Multiplate are used to predict bleeding in cardiac surgery and hepatic transplantation, and targeted therapy based on their results is associated with a reduction in blood transfusion (FFP, platelets, erythrocytes) administration, reduced bleeding and reduced morbidity and mortality (5-7).
Therefore, it can reasonably be assumed that a similar positive benefit of this POC approach can be expected even in patients undergoing lung transplantation.
In this prospective controlled randomized study of 120 lung transplant patients, investigators want to compare the incidence of PGD between a group of patients treated by standard ,,blind" approach and a ,,new" POC approach. Investigators assume that in a group where diagnosis and therapy of coagulopathy and bleeding will be managed based on the results of the ROTEM, PFA 200 and Multiplate tests, the clot strength will be increased and this will lead to reduced perioperative blood loss, reduced administration of infusion solutions and FFP and this will subsequently lead to reduced incidence of PGD.
Hypothesis:
Point-of-care approach to diagnosis of perioperative coagulopathy with ROTEM, PFA 200 and Multiplate and its subsequent aimed therapy will improve blood clot and thus will reduce blood loss, fluid infusion, blood transfusion and subsequently the incidence of PGD.
Methodology:
Patients undergoing bilateral lung transplantation (120 patients) will be randomized into 2 groups using computerised generator of random numbers. The study protocol will be registered in the Clinical Research Database and a clinical trial number (CTN) will be obtained and written informed consent will be obtained from patients before lung transplantation.
The first group of existing ,,standard care" - the approach to bleeding patient will be based on clinical experience of the anaesthetist, practically meaning administering crystalloids, colloids (hydroxyethyl starch or gelatin), fresh frozen plasma and erythrocytes to restore normovolemia and platelets, fibrinogen, prothrombin complex concentrate, von Willebrand factor, tranexamic acid, all products giving ,,blindly" when it comes to diagnosis and treatment of coagulopathy.
The second group of ,,point-of-care" approach to the diagnosis and treatment of perioperative bleeding and coagulopathy will be conducted on the basis of the results of the POC methods ROTEM, PFA 200 and Multiplate (prothrombin complex concentrate, fibrinogen, platelets, von Willebrand factor, tranexamic acid). A solution of 5% albumin and erythrocytes (to keep haemoglobin level over 100 g/l as it is critical for normal primary haemostasis) will be used to keep normal circulating volume and to compensate for perioperative blood loss.
Blood samples will obtained and analysed by ROTEM, PFA 200 and Multiplate, as well as the level and function of von Willebrand factor (multimers assay, ristocetin cofactor and collagen binding assay) will be performed in all patients:
1. before lung transplantation, upon patient arrival to hospital before surgery (as a control)
2. after lung transplantation, during admission of patient to postoperative intensive care unit
3. in the ,,POC" group also in the operating room (ROTEM, Multiplate and PFA 200) during surgery
The PGD score will be evaluated post-operatively and in the following way: severity of PGD is defined in four degrees and is evaluated using partial arterial oxygen pressure (PaO2) and inspired fraction of oxygen ratio (FiO2) ratio and simultaneously evaluating X-ray finding of the lungs as soon as possible after reperfusion (time 0) and after 48 and 72 hours after lung reperfusion.
* Grade 0 - PaO2/FiO2 ratio of any value but no pulmonary edema on chest X-ray
* Grade 1 - PaO2/FiO2 \> 300 and presence of pulmonary edema on chest X-ray
* Grade 2 - PaO2/FiO2 200 - 300 and and presence of pulmonary edema on chest X-ray
* Grade 3 - PaO2/FiO2 \< 200 and presence of pulmonary edema on chest X-ray or patients in need of postoperative ECMO support or nitric oxide therapy
To exclude the possible thrombotic complication of any of these approaches, each patient will be screened ultrasonographically for venous thrombosis 72 hours postoperatively (vena poplitea, vena femoralis, vena jugularis, and vena subclavia bilat) and thrombotic complications will compared between groups.
Also other parameters will be compared between groups:
* clot strength and whole coagulation profile before and after surgery using ROTEM, PFA 200 and Multiplate and evaluation of the functional level of von Willebrand factor. Correlation of coagulation profile with blood loss in the operating room and postoperative blood loss will be also assessed.
* amount of perioperative blood loss in the operating room at the end of surgery and 24 hours after surgery (blood loss will measured as amount of blood in the suction container in operating room and as amount of blood in the chest drain in ICU postoperatively)
* number of transfusion products administered in operating room and in postoperative ICU
* duration of invasive and noninvasive mechanical ventilation and time to extubation (hours), duration of stay in the postoperative ICU and overall in hospital before discharge home (days)
* morbidity of patients (SOFA score at 24, 48 and 72 hours after lung transplantation), morbidity and mortality among patients in 30, 90 and 365 days
* incidence of lung graft rejection during whole period of hospitalisation
Time schedule: 4 years During the 3-years period recruitment of patients will be done and in the 4-th year data will be analysed and published in valuable journals.
Investigators expect a lower consumption of blood transfusion products and infusion solutions in the POC group.
In case of lower PGD incidence in the POC group investigators expect shorter time of mechanical ventilation, a shorter period of hospitalization at the postoperative ICU and in the hospital overall and a lower incidence of pulmonary graft rejection.
Investigators expect lower morbidity and mortality of patients in the POC group.
Investigators also believe that the POC approach will reduce the total hospitalisation costs.
Conditions
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Lung Transplantation
Study Design
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Observational Model Type
OTHER
Study Time Perspective
PROSPECTIVE
Study Groups
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Standard management of coagulopathy
The first group of existing ,,standard care" - the approach to bleeding patient will be based on clinical experience of the anaesthetist, practically meaning administering crystalloids, colloids (hydroxyethyl starch or gelatin), fresh frozen plasma and erythrocytes to restore normovolemia and platelets, fibrinogen, prothrombin complex concentrate, von Willebrand factor, tranexamic acid, all products giving ,,blindly" when it comes to diagnosis and treatment of coagulopathy.
Fresh frozen plasma
Intervention Type
OTHER
Fresh frozen plasma will be used according to anaesthetist ,,blind,, decision
POC management of coagulopathy
group of ,,point-of-care" approach to the diagnosis and treatment of perioperative bleeding and coagulopathy will be conducted on the basis of the results of the POC methods ROTEM, PFA 200 and Multiplate (prothrombin complex concentrate, fibrinogen, platelets, von Willebrand factor, tranexamic acid). A solution of 5% albumin and erythrocytes (to keep haemoglobin level over 100 g/l as it is critical for normal primary haemostasis) will be used to keep normal circulating volume and to compensate for perioperative blood loss.
No interventions assigned to this group
Interventions
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Fresh frozen plasma
Fresh frozen plasma will be used according to anaesthetist ,,blind,, decision
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
* Patients over 18 years
* Indicated for bilateral lung transplantation with diagnosis of interstitial pulmonary fibrosis, cystic fibrosis, chronic obstructive pulmonary disease, exogenous allergic alveolitis
* Indicated for bilateral lung transplantation with diagnosis of interstitial pulmonary fibrosis, cystic fibrosis, chronic obstructive pulmonary disease, exogenous allergic alveolitis
Exclusion Criteria
* Patients requiring plasmapheresis before lung transplantation
* Patients waiting for lung transplantation on ECMO (ECMO used as bridging to surgery)
* Patients undergoing simultaneous lung and heart transplantation
* Patients waiting for lung transplantation on ECMO (ECMO used as bridging to surgery)
* Patients undergoing simultaneous lung and heart transplantation
Minimum Eligible Age
18 Years
Maximum Eligible Age
80 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University Hospital, Motol
OTHER
Sponsor Role
lead
Responsible Party
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Durila Miroslav MUDr. Ph.D.
associate professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Miroslav Durila, assoc.prof.
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Motol
Locations
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University Hospital Motol, Department of Anaesthesiology and Intensive Care
Prague, , Czechia
Site Status
Countries
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Czechia
References
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Snell GI, Yusen RD, Weill D, Strueber M, Garrity E, Reed A, Pelaez A, Whelan TP, Perch M, Bag R, Budev M, Corris PA, Crespo MM, Witt C, Cantu E, Christie JD. Report of the ISHLT Working Group on Primary Lung Graft Dysfunction, part I: Definition and grading-A 2016 Consensus Group statement of the International Society for Heart and Lung Transplantation. J Heart Lung Transplant. 2017 Oct;36(10):1097-1103. doi: 10.1016/j.healun.2017.07.021. Epub 2017 Jul 26. No abstract available.
Reference Type
BACKGROUND
Diamond JM, Arcasoy S, Kennedy CC, Eberlein M, Singer JP, Patterson GM, Edelman JD, Dhillon G, Pena T, Kawut SM, Lee JC, Girgis R, Dark J, Thabut G. Report of the International Society for Heart and Lung Transplantation Working Group on Primary Lung Graft Dysfunction, part II: Epidemiology, risk factors, and outcomes-A 2016 Consensus Group statement of the International Society for Heart and Lung Transplantation. J Heart Lung Transplant. 2017 Oct;36(10):1104-1113. doi: 10.1016/j.healun.2017.07.020. Epub 2017 Jul 26. No abstract available.
Reference Type
BACKGROUND
Gelman AE, Fisher AJ, Huang HJ, Baz MA, Shaver CM, Egan TM, Mulligan MS. Report of the ISHLT Working Group on Primary Lung Graft Dysfunction Part III: Mechanisms: A 2016 Consensus Group Statement of the International Society for Heart and Lung Transplantation. J Heart Lung Transplant. 2017 Oct;36(10):1114-1120. doi: 10.1016/j.healun.2017.07.014. Epub 2017 Jul 24. No abstract available.
Reference Type
BACKGROUND
Gorlinger K, Saner FH. Prophylactic plasma and platelet transfusion in the critically Ill patient: just useless and expensive or even harmful? BMC Anesthesiol. 2015 Jun 9;15:86. doi: 10.1186/s12871-015-0074-0.
Reference Type
BACKGROUND
Keene DD, Nordmann GR, Woolley T. Rotational thromboelastometry-guided trauma resuscitation. Curr Opin Crit Care. 2013 Dec;19(6):605-12. doi: 10.1097/MCC.0000000000000021.
Reference Type
BACKGROUND
Hagemo JS, Christiaans SC, Stanworth SJ, Brohi K, Johansson PI, Goslings JC, Naess PA, Gaarder C. Detection of acute traumatic coagulopathy and massive transfusion requirements by means of rotational thromboelastometry: an international prospective validation study. Crit Care. 2015 Mar 23;19(1):97. doi: 10.1186/s13054-015-0823-y.
Reference Type
BACKGROUND
Mutlak H, Reyher C, Meybohm P, Papadopoulos N, Hanke AA, Zacharowski K, Weber CF. Multiple electrode aggregometry for the assessment of acquired platelet dysfunctions during extracorporeal circulation. Thorac Cardiovasc Surg. 2015 Feb;63(1):21-7. doi: 10.1055/s-0034-1383817. Epub 2014 Aug 1.
Reference Type
BACKGROUND
Kalbhenn J, Schlagenhauf A, Rosenfelder S, Schmutz A, Zieger B. Acquired von Willebrand syndrome and impaired platelet function during venovenous extracorporeal membrane oxygenation: Rapid onset and fast recovery. J Heart Lung Transplant. 2018 Aug;37(8):985-991. doi: 10.1016/j.healun.2018.03.013. Epub 2018 Mar 17.
Reference Type
BACKGROUND
Bogdanic D, Karanovic N, Mratinovic-Mikulandra J, Paukovic-Sekulic B, Brnic D, Marinovic I, Nonkovic D, Bogdanic N. The Role of Platelet Function Analyzer Testing in Cardiac Surgery Transfusion Management. Transfus Med Hemother. 2017 Apr;44(2):106-113. doi: 10.1159/000452863. Epub 2017 Feb 1.
Reference Type
BACKGROUND
Ellis J, Valencia O, Crerar-Gilbert A, Phillips S, Meeran H, Sharma V. Point-of-care platelet function testing to predict blood loss after coronary artery bypass grafting surgery: a prospective observational pilot study. Perfusion. 2016 Nov;31(8):676-682. doi: 10.1177/0267659116656774. Epub 2016 Jul 10.
Reference Type
BACKGROUND
Deppe AC, Weber C, Zimmermann J, Kuhn EW, Slottosch I, Liakopoulos OJ, Choi YH, Wahlers T. Point-of-care thromboelastography/thromboelastometry-based coagulation management in cardiac surgery: a meta-analysis of 8332 patients. J Surg Res. 2016 Jun 15;203(2):424-33. doi: 10.1016/j.jss.2016.03.008. Epub 2016 Mar 26.
Reference Type
BACKGROUND
Pearse BL, Smith I, Faulke D, Wall D, Fraser JF, Ryan EG, Drake L, Rapchuk IL, Tesar P, Ziegenfuss M, Fung YL. Protocol guided bleeding management improves cardiac surgery patient outcomes. Vox Sang. 2015 Oct;109(3):267-79. doi: 10.1111/vox.12279. Epub 2015 Apr 30.
Reference Type
BACKGROUND
Leon-Justel A, Noval-Padillo JA, Alvarez-Rios AI, Mellado P, Gomez-Bravo MA, Alamo JM, Porras M, Barrero L, Hinojosa R, Carmona M, Vilches-Arenas A, Guerrero JM. Point-of-care haemostasis monitoring during liver transplantation reduces transfusion requirements and improves patient outcome. Clin Chim Acta. 2015 Jun 15;446:277-83. doi: 10.1016/j.cca.2015.04.022. Epub 2015 Apr 25.
Reference Type
BACKGROUND
Durila M, Vajter J, Garaj M, Pollert L, Berousek J, Vachtenheim J Jr, Vymazal T, Lischke R. Rotational thromboelastometry reduces blood loss and blood product usage after lung transplantation. J Heart Lung Transplant. 2021 Jul;40(7):631-641. doi: 10.1016/j.healun.2021.03.020. Epub 2021 Mar 29.
Reference Type
RESULT
Vajter J, Vachtenheim J Jr, Prikrylova Z, Berousek J, Vymazal T, Lischke R, Martin AK, Durila M. Effect of targeted coagulopathy management and 5% albumin as volume replacement therapy during lung transplantation on allograft function: a secondary analysis of a randomized clinical trial. BMC Pulm Med. 2023 Mar 9;23(1):80. doi: 10.1186/s12890-023-02372-0.
Reference Type
RESULT
Durila M, Vajter J, Garaj M, Smetak T, Hedvicak P, Berousek J, Vymazal T. Acquired primary hemostasis pathology detected by platelet function analyzer 200 seen during extracorporeal membrane oxygenation is sufficient to prevent circuit thrombosis: A pilot study. J Heart Lung Transplant. 2020 Sep;39(9):980-982. doi: 10.1016/j.healun.2020.05.015. Epub 2020 Jun 11. No abstract available.
Reference Type
DERIVED
Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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NV19-06-00471
Identifier Type: -
Identifier Source: org_study_id
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NCT06961175
RECRUITING
Management of Coagulopathy During Orthotopic Liver Transplantation. Comparison Between ROTEM-based Management and Standard Biological Assessment.
NCT02352181
COMPLETED
NA
Implementation of an Empiric Transfusion Bundle for Out of Hospital Patients With Haemorrhagic Shock
NCT06891131
RECRUITING
Blood Products Transfusion in Cardiac Surgery After the Implementation of a Coagulation Monitoring System at Patient Bedside: Thromboelastometry Versus Standard Transfusion Protocol
NCT01919840
TERMINATED
PHASE4
An Observational Study of Early Coagulopathy, or Clotting Disorder, in Injured Patients
NCT00744003
WITHDRAWN
Management of Anticoagulant Therapy in Non-cardiac Surgery.
NCT04766606
COMPLETED
Transfusion and Coagulation Management in Trauma Patients After the Introduction of a Coagulation Algorithm
NCT02569606
COMPLETED
Perioperative Coagulation Management in Cardiac Surgery.
NCT00772239
TERMINATED
NA
Transfusion Requirements After Orthotopic Liver Transplantation
NCT01435746
WITHDRAWN
NA
Anticoagulation Medicine in Surgical Repair for Total Anomalous Pulmonary Venous Connection
NCT04241380
UNKNOWN
NA