Trial Outcomes & Findings for Point-of-care Management of Coagulopathy in Lung Transplantation (NCT NCT03598907)

Last Updated: 2025-06-10

Results Overview

Total estimated blood loss measured during the perioperative period of lung transplantation (including intraoperative and immediate postoperative period).

Recruitment status

TERMINATED

Target enrollment

100 participants

Primary outcome timeframe

From the beginning of surgery to 24 hours postoperatively

Results posted on

2025-06-10

Participant Flow

After performing an interim statistical analysis of the results in approximatelly the middle of the study, the project was prematurely terminated as it would have been unethical to continue.

Total number of patients anticipated in the study was 120, meaning 60 patients in every group.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	50	50
Overall Study COMPLETED	36	31
Overall Study NOT COMPLETED	14	19

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Physician Decision	14	19

Baseline Characteristics

Point-of-care Management of Coagulopathy in Lung Transplantation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	"Non POC" Group n=36 Participants the management of perioperative bleeding and coagulopathy and the administration of RBC, FFP, and PLT was based on the clinical experience of the anesthesiologist	"POC Group" n=31 Participants the management of perioperative bleeding and coagulopathy based on results of POC method such as ROTEM	Total n=67 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	36 Participants n=5 Participants	31 Participants n=7 Participants	67 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	56 years STANDARD_DEVIATION 9 • n=5 Participants	45 years STANDARD_DEVIATION 16 • n=7 Participants	50.5 years STANDARD_DEVIATION 12.5 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	20 Participants n=7 Participants	45 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	36 Participants n=5 Participants	31 Participants n=7 Participants	67 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Czechia	36 participants n=5 Participants	31 participants n=7 Participants	67 participants n=5 Participants

PRIMARY outcome

Timeframe: From the beginning of surgery to 24 hours postoperatively

Population: All randomized patients who underwent lung transplantation

Total estimated blood loss measured during the perioperative period of lung transplantation (including intraoperative and immediate postoperative period).

Outcome measures

Outcome measures
Measure	Non POC Group n=36 Participants Bleeding and coagulopathy was managed based on clinical approach of anesthesiologist.	POC Group n=31 Participants Bleeding and coagulopathy was managed according to results of point of care tests ROTEM, PFA 200 and Multiplate.
Perioperative Blood Loss	1043 mL Standard Deviation 547	682 mL Standard Deviation 399

OTHER_PRE_SPECIFIED outcome

Timeframe: After surgery at 0 hours

PGD 0-1 and 2-3 differences between POC versus Non-POC group. Primary graft dysfunction (PGD) in lung transplant patients is described as acute pulmonary damage occurring early in lung transplantation. The 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 after surgery. * 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

Outcome measures

Outcome measures
Measure	Non POC Group n=36 Participants Bleeding and coagulopathy was managed based on clinical approach of anesthesiologist.	POC Group n=31 Participants Bleeding and coagulopathy was managed according to results of point of care tests ROTEM, PFA 200 and Multiplate.
Primary Graft Dysfunction (PGD) PGD 0-1	22 Participants	24 Participants
Primary Graft Dysfunction (PGD) PGD 2-3	14 Participants	7 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: After surgry at 24 hours

PGD 0-1 and 2-3 differences between POC versus Non-POC group PGD 0-1 and 2-3 differences between POC versus Non-POC group. Primary graft dysfunction (PGD) in lung transplant patients is described as acute pulmonary damage occurring early in lung transplantation. The 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 after surgery. * 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

Outcome measures

Outcome measures
Measure	Non POC Group n=36 Participants Bleeding and coagulopathy was managed based on clinical approach of anesthesiologist.	POC Group n=31 Participants Bleeding and coagulopathy was managed according to results of point of care tests ROTEM, PFA 200 and Multiplate.
Primary Graft Dysfunction (PGD) PGD 0-1	28 Participants	28 Participants
Primary Graft Dysfunction (PGD) PGD 2-3	8 Participants	3 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: After surgry at 48 hours

PGD 0-1 and 2-3 differences between POC versus Non-POC group. PGD 0-1 and 2-3 differences between POC versus Non-POC group. Primary graft dysfunction (PGD) in lung transplant patients is described as acute pulmonary damage occurring early in lung transplantation. The 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 after surgery. * 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

Outcome measures

Outcome measures
Measure	Non POC Group n=36 Participants Bleeding and coagulopathy was managed based on clinical approach of anesthesiologist.	POC Group n=31 Participants Bleeding and coagulopathy was managed according to results of point of care tests ROTEM, PFA 200 and Multiplate.
Primary Graft Dysfunction (PGD) PGD 0-1	27 Participants	26 Participants
Primary Graft Dysfunction (PGD) PGD 2-3	9 Participants	5 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: After surgry at 72 hours

Outcome measures

Outcome measures
Measure	Non POC Group n=36 Participants Bleeding and coagulopathy was managed based on clinical approach of anesthesiologist.	POC Group n=31 Participants Bleeding and coagulopathy was managed according to results of point of care tests ROTEM, PFA 200 and Multiplate.
Primary Graft Dysfunction (PGD) PGD 0-1	27 Participants	30 Participants
Primary Graft Dysfunction (PGD) PGD 2-3	9 Participants	1 Participants

Adverse Events

Standard Management of Coagulopathy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

POC Management of Coagulopathy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

prof. Miroslav Durila

Department of anesthesiology and intensive care medicine, Charles University and Motol Hospital

Phone: +420224435440

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place