Coagulation DisorderTHROMBINNCT03616808
Thromboelastometry-identified Haemostatic Changes in Isolated Traumatic Brain Injury
A study testing Thromboelastometry-guided haemostatic treatment in people with Coagulation Disorder and Brain Injuries, Traumatic, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
Trial summary
A prospective open-label case-control study will be performed aiming to assess the utility of thromboelastometry (ROTEM) for identification of hemostatic changes, goal-directed coagulation management, and prognosis of intracranial hemorrhagic injury progression as well as clinical outcome in patients with isolated… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coagulation Disorder, Brain Injuries, Traumatic, Bleeding
- What is being tested?
- Thromboelastometry-guided haemostatic treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteLithuania
- Study dates
- 21 Aug 2018to 31 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Isolated traumatic brain injury (within 48 hours) (AIS head >= 3)
- Urgent craniotomy is necessary
- A written informed consent is acquired from the patient or his/her representative
Who cannot join
- Refusal / inability to acquire an informed consent
- Significant trauma to other body regions (AIS other regions >= 3)
- Data on significant chronic hepatic or hematologic illness
- Use of oral anticoagulants or antiplatelet agents
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Lithuania1 site
Hospital of Lithuanian University of Health Sciences
Kaunas, LT-50009
About this study
Official title: The Influence of Thromboelastometry-identified Haemostatic Changes on Haemorrhagic Progression of Intracranial Injury and Clinical Outcome in Patients With Isolated Traumatic Brain Injury
A prospective open-label case-control study will be performed aiming to assess the utility of thromboelastometry (ROTEM) for identification of hemostatic changes, goal-directed coagulation management, and prognosis of intracranial hemorrhagic injury progression as well as clinical outcome in patients with isolated traumatic brain injury. Patients undergoing craniotomy to treat traumatic brain injury will be enrolled. All patients will undergo standard perioperative coagulation analysis (APTT, PT, INR, fibrinogen levels, platelet count), whereas ROTEM-guided group will additionally be tested with ROTEM. "Cases" will be managed according to a ROTEM-based algorithm, and "Controls" will be treated as usual (based on clinical judging). Comparative analysis of acquired demographic, clinical and laboratory data will be performed. The investigators believe that ROTEM results could provide better insight into perioperative coagulation changes, be beneficial to patient blood management, and result in better outcome.
Read the detailed description
Aim of the study:
To assess the utility of thromboelastometry for identification of hemostatic changes, goal-directed coagulation management, and prognosis of intracranial hemorrhagic injury progression as well as clinical outcome in patients with isolated traumatic brain injury.
Objectives:
To evaluate perioperative prevalence and characteristics of thromboelastometry identified coagulopathy in neurosurgical patients with isolated traumatic brain injury; To assess the correlation between routine laboratory test results and thromboelastometric findings; To evaluate the influence of thromboelastometric findings and goal-directed coagulation management on the progression of intracranial hemorrhagic injury; To evaluate the utility of thromboelastometry for goal-directed coagulation management, and its possible influence on clinical outcome.
Study background:
Traumatic brain injury still accounts for a considerable proportion of preventable deaths worldwide. The prevalence of coagulation derangements among patients with traumatic brain injury (TBI) is high and approximates 30 % (1,2). The main hypothesis explaining the development of coagulopathy in the absence of massive bleeding is extensive release of tissue factor from the damaged brain tissue and subsequent over-activation of coagulation leading to consumption of coagulation substrates. The presence of coagulopathy in the setting of TBI is associated with high risk of intracranial hemorrhagic insult progression and death (3,4). Many authors investigating coagulopathy associated with traumatic brain injury have used routine coagulation tests, such as APTT, PT, INR, fibrinogen levels. However, those tests do not reflect the overall clot quality and reflect only separate parts of the coagulation process.
Craniotomy for traumatic brain injury is an urgent high-risk procedure presenting a serious challenge for the anesthesiology team. Significant, diffuse bleeding is not infrequent, and the spectrum of neurosurgical hemostatic options is limited. Moreover, even small amounts of intracranial blood may be life-threatening. Therefore the maintenance of optimal physiologic clotting capacity is crucial. Literature data investigating the use of ROTEM in TBI patients is still limited (5,6).
The investigators believe that thromboelastometry could provide novel insights into the dynamic coagulation changes of TBI patients. Moreover, it could serve as a clinical tool for targeted coagulation management in the perioperative period of patients undergoing craniotomies for intracranial traumatic hematomas, and prove beneficial for patient outcome.
Materials and methods:
A prospective open-label case-control study will be performed. Adult isolated traumatic brain injury patients undergoing craniotomy and will be enrolled. Required sample size was calculated based on the average number of craniotomies performed to treat traumatic brain injury during the past five years in a tertiary neurosurgical centre. The investigators plan to enroll 70 patients into the ROTEM-guided group (Cases), and 70 patients into the conventional therapy group (Controls). All patients will undergo standard coagulation analysis (APTT, PT, INR, fibrinogen levels, platelet count) preoperatively, and 3 days postoperatively, whereas ROTEM-guided group patients will additionally be tested with ROTEM (EXTEM, INTEM, FIBTEM, APTEM). Coagulation management decisions in the ROTEM-guided group will be made according to a ROTEM-based algorithm for goal-directed hemostatic therapy. Conventional therapy group will be treated as usual. Perioperative demographic, clinical and laboratory data of study patients will be registered. Early neurological state (on postoperative days 1,2,3,7, and until discharge) will be assessed according to the Glasgow coma scale. Late neurological outcome (6 and 12 months postoperatively) will be assessed according to Glasgow outcome scale. Comparative analysis of Case and Control groups will be performed. Perioperative prevalence and characteristics of coagulopathy in neurosurgical patients with isolated traumatic brain injury will be estimated. Correlation between routine laboratory test results and thromboelastometric findings will be assessed. The influence of thromboelastometric findings and goal-directed coagulation management on the progression of intracranial hemorrhagic injury will be assessed. The influence of goal-directed coagulation management on clinical outcome will be evaluated.
Anticipated scientific and clinical benefits:
The investigators believe that ROTEM results could provide better insight into perioperative coagulation changes, be beneficial to patient blood management, and result in better outcome.
- Conditions
- Coagulation Disorder, Brain Injuries, Traumatic, Bleeding
- Being tested
- Thromboelastometry-guided haemostatic treatment
- Keywords
- Traumatic brain injury, Craniotomy, Goal-directed treatment, Thromboelastometry
- Medical subject headings
- Hemostatic Disorders, Brain Injuries, Traumatic, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thromboelastometry-guided haemostatic treatmentOther
Administration of blood products and/or procoagulants is based on thromboelastometric assays.
| Study group | Role | What they receive |
|---|---|---|
| Conventional therapy | No intervention | Intraoperative haemostatic treatment is based on conventional coagulation assays. |
| Goal-directed therapy | Active comparator | Thromboelastometry-guided haemostatic treatment is provided intraoperatively. Receives: Other: Thromboelastometry-guided haemostatic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Mortality of patients in both groups
Measured: 30 days
Early neurological state according to Glasgow coma scale
Glasgow coma scale (GCS) is used to objectively assess the level of consciousness after neurological injury according to best eye (range 1 to 4), verbal (range 1 to 5) and motor (range 1 to 6) response of the patient. Eye, verbal and motor scores are summed to give the total Glasgow coma score (range 3 to 15). The lowest possible GCS (the sum) is 3 (deep coma or death), while the highest is 15 (fully awake person).
Measured: 30 days
Secondary outcomes (3)
Coagulation abnormalities on conventional coagulation assays and ROTEM
The number of patients with abnormal results of PT (prothrombin time), INR (international normalized ratio), APTT (activated partial thromboplastin time), fibrinogen concentration, platelet count and/or any abnormal thromboelastometric (ROTEM) parameter
Measured: 72 hours
Progressive hemorrhagic injury
Evidence of new or increased intracranial hemorrhagic injury
Measured: 30 days
Clinical outcome according to Glasgow outcome score
The Glasgow Outcome Score (GOS) is used to divide patients with traumatic brain injury into groups (range 1 to 5) that allow standardised descriptions of the objective degree of recovery as follows:
- Death
- Persistent vegetative state - Severe damage with prolonged state of unresponsiveness and a lack of higher mental functions
- Severe disability - Severe injury with permanent need for help with daily living
- Moderate disability - No need for assistance in everyday life, employment is possible but may require special equipment
- Low disability - Light damage with minor neurological and psychological deficits
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start21 Aug 2018
- Primary completion30 Aug 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Coagulation DisorderStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A case-control study. Conventional management patients are considered as "controls" whereas goal-directed management patients will be considered "cases".
- Masking
- None (open label)
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MARIUS RIMAITIS, Lithuanian University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03616808
- Sponsor's protocol ID
- V2
- Acronym
- THROMBIN
- Status last verified
- Apr 2021
- First submitted
- 13 Jul 2018
- Last updated
- 6 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wafaisade A, Lefering R, Tjardes T, Wutzler S, Simanski C, Paffrath T, Fischer P, Bouillon B, Maegele M; Trauma Registry of DGU. Acute coagulopathy in isolated blunt traumatic brain injury. Neurocrit Care. 2010 Apr;12(2):211-9. doi: 10.1007/s12028-009-9281-1.
PubMed 19806475Harhangi BS, Kompanje EJ, Leebeek FW, Maas AI. Coagulation disorders after traumatic brain injury. Acta Neurochir (Wien). 2008 Feb;150(2):165-75; discussion 175. doi: 10.1007/s00701-007-1475-8. Epub 2008 Jan 2.
PubMed 18166989Maegele M. Coagulopathy after traumatic brain injury: incidence, pathogenesis, and treatment options. Transfusion. 2013 Jan;53 Suppl 1:28S-37S. doi: 10.1111/trf.12033.
PubMed 23301970de Oliveira Manoel AL, Neto AC, Veigas PV, Rizoli S. Traumatic brain injury associated coagulopathy. Neurocrit Care. 2015 Feb;22(1):34-44. doi: 10.1007/s12028-014-0026-4.
PubMed 25052157Brazinova A, Majdan M, Leitgeb J, Trimmel H, Mauritz W; Austrian Working Group on Improvement of Early TBI Care. Factors that may improve outcomes of early traumatic brain injury care: prospective multicenter study in Austria. Scand J Trauma Resusc Emerg Med. 2015 Jul 16;23:53. doi: 10.1186/s13049-015-0133-z.
PubMed 26179747Schochl H, Solomon C, Traintinger S, Nienaber U, Tacacs-Tolnai A, Windhofer C, Bahrami S, Voelckel W. Thromboelastometric (ROTEM) findings in patients suffering from isolated severe traumatic brain injury. J Neurotrauma. 2011 Oct;28(10):2033-41. doi: 10.1089/neu.2010.1744. Epub 2011 Sep 23.
PubMed 21942848Rimaitis M, Cechanoviciute V, Bilskiene D, Balciuniene N, Vilcinis R, Rimaitis K, Macas A. Dynamic Changes of Hemostasis in Patients with Traumatic Brain Injury Undergoing Craniotomy: Association with in-Hospital Mortality. Neurocrit Care. 2023 Jun;38(3):714-725. doi: 10.1007/s12028-022-01639-4. Epub 2022 Dec 5.
PubMed 36471184
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Thromboelastometry-identified Haemostatic Changes on Haemorrhagic Progression of Intracranial Injury and Clinical Outcome in Patients With Isolated Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT03616808
- Acronym / sponsor ID
- THROMBIN / V2
- Conditions
- Coagulation Disorder, Brain Injuries, Traumatic, Bleeding
- Keywords
- Traumatic brain injury, Craniotomy, Goal-directed treatment, Thromboelastometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Study start
- 21 Aug 2018 (actual)
- Primary completion
- 30 Aug 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 6 Aug 2018 (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.
A prospective open-label case-control study will be performed aiming to assess the utility of thromboelastometry (ROTEM) for identification of hemostatic changes, goal-directed coagulation management, and prognosis of intracranial hemorrhagic injury progression as well as clinical outcome in patients with isolated traumatic brain injury. Patients undergoing craniotomy to treat traumatic brain injury will be enrolled. All patients will undergo standard perioperative coagulation analysis (APTT, PT, INR, fibrinogen levels, platelet count), whereas ROTEM-guided group will additionally be tested with ROTEM. "Cases" will be managed according to a ROTEM-based algorithm, and "Controls" will be treated as usual (based on clinical judging). Comparative analysis of acquired demographic, clinical and laboratory data will be performed. The investigators believe that ROTEM results could provide better insight into perioperative coagulation changes, be beneficial to patient blood management, and result in better outcome.
Detailed description
Aim of the study:
To assess the utility of thromboelastometry for identification of hemostatic changes, goal-directed coagulation management, and prognosis of intracranial hemorrhagic injury progression as well as clinical outcome in patients with isolated traumatic brain injury.
Objectives:
To evaluate perioperative prevalence and characteristics of thromboelastometry identified coagulopathy in neurosurgical patients with isolated traumatic brain injury; To assess the correlation between routine laboratory test results and thromboelastometric findings; To evaluate the influence of thromboelastometric findings and goal-directed coagulation management on the progression of intracranial hemorrhagic injury; To evaluate the utility of thromboelastometry for goal-directed coagulation management, and its possible influence on clinical outcome.
Study background:
Traumatic brain injury still accounts for a considerable proportion of preventable deaths worldwide. The prevalence of coagulation derangements among patients with traumatic brain injury (TBI) is high and approximates 30 % (1,2). The main hypothesis explaining the development of coagulopathy in the absence of massive bleeding is extensive release of tissue factor from the damaged brain tissue and subsequent over-activation of coagulation leading to consumption of coagulation substrates. The presence of coagulopathy in the setting of TBI is associated with high risk of intracranial hemorrhagic insult progression and death (3,4). Many authors investigating coagulopathy associated with traumatic brain injury have used routine coagulation tests, such as APTT, PT, INR, fibrinogen levels. However, those tests do not reflect the overall clot quality and reflect only separate parts of the coagulation process.
Craniotomy for traumatic brain injury is an urgent high-risk procedure presenting a serious challenge for the anesthesiology team. Significant, diffuse bleeding is not infrequent, and the spectrum of neurosurgical hemostatic options is limited. Moreover, even small amounts of intracranial blood may be life-threatening. Therefore the maintenance of optimal physiologic clotting capacity is crucial. Literature data investigating the use of ROTEM in TBI patients is still limited (5,6).
The investigators believe that thromboelastometry could provide novel insights into the dynamic coagulation changes of TBI patients. Moreover, it could serve as a clinical tool for targeted coagulation management in the perioperative period of patients undergoing craniotomies for intracranial traumatic hematomas, and prove beneficial for patient outcome.
Materials and methods:
A prospective open-label case-control study will be performed. Adult isolated traumatic brain injury patients undergoing craniotomy and will be enrolled. Required sample size was calculated based on the average number of craniotomies performed to treat traumatic brain injury during the past five years in a tertiary neurosurgical centre. The investigators plan to enroll 70 patients into the ROTEM-guided group (Cases), and 70 patients into the conventional therapy group (Controls). All patients will undergo standard coagulation analysis (APTT, PT, INR, fibrinogen levels, platelet count) preoperatively, and 3 days postoperatively, whereas ROTEM-guided group patients will additionally be tested with ROTEM (EXTEM, INTEM, FIBTEM, APTEM). Coagulation management decisions in the ROTEM-guided group will be made according to a ROTEM-based algorithm for goal-directed hemostatic therapy. Conventional therapy group will be treated as usual. Perioperative demographic, clinical and laboratory data of study patients will be registered. Early neurological state (on postoperative days 1,2,3,7, and until discharge) will be assessed according to the Glasgow coma scale. Late neurological outcome (6 and 12 months postoperatively) will be assessed according to Glasgow outcome scale. Comparative analysis of Case and Control groups will be performed. Perioperative prevalence and characteristics of coagulopathy in neurosurgical patients with isolated traumatic brain injury will be estimated. Correlation between routine laboratory test results and thromboelastometric findings will be assessed. The influence of thromboelastometric findings and goal-directed coagulation management on the progression of intracranial hemorrhagic injury will be assessed. The influence of goal-directed coagulation management on clinical outcome will be evaluated.
Anticipated scientific and clinical benefits:
The investigators believe that ROTEM results could provide better insight into perioperative coagulation changes, be beneficial to patient blood management, and result in better outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A case-control study. Conventional management patients are considered as "controls" whereas goal-directed management patients will be considered "cases".
| Arm | Type | Receives |
|---|---|---|
| Conventional therapy | No intervention | –Intraoperative haemostatic treatment is based on conventional coagulation assays. |
| Goal-directed therapy | Active comparator | Other: Thromboelastometry-guided haemostatic treatmentThromboelastometry-guided haemostatic treatment is provided intraoperatively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Isolated traumatic brain injury (within 48 hours) (AIS head >= 3)
- Urgent craniotomy is necessary
- A written informed consent is acquired from the patient or his/her representative
Key exclusion criteria (5 listed)
- Refusal / inability to acquire an informed consent
- Significant trauma to other body regions (AIS other regions >= 3)
- Data on significant chronic hepatic or hematologic illness
- Use of oral anticoagulants or antiplatelet agents
- Pregnancy
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 |
|---|---|---|
| Thromboelastometry-guided haemostatic treatmentAdministration of blood products and/or procoagulants is based on thromboelastometric assays. | Other | Goal-directed therapy |
Primary outcome
Mortality
Time frame: 30 days
Mortality of patients in both groups
Early neurological state according to Glasgow coma scale
Time frame: 30 days
Glasgow coma scale (GCS) is used to objectively assess the level of consciousness after neurological injury according to best eye (range 1 to 4), verbal (range 1 to 5) and motor (range 1 to 6) response of the patient. Eye, verbal and motor scores are summed to give the total Glasgow coma score (range 3 to 15). The lowest possible GCS (the sum) is 3 (deep coma or death), while the highest is 15 (fully awake person).
3 secondary outcomes
Coagulation abnormalities on conventional coagulation assays and ROTEM
Time frame: 72 hours
Progressive hemorrhagic injury
Time frame: 30 days
Clinical outcome according to Glasgow outcome score
Time frame: Up to 1 year
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 6 Apr 2021.
- Background: PubMed 19806475Wafaisade A, Lefering R, Tjardes T, Wutzler S, Simanski C, Paffrath T, Fischer P, Bouillon B, Maegele M; Trauma Registry of DGU. Acute coagulopathy in isolated blunt traumatic brain injury. Neurocrit Care. 2010 Apr;12(2):211-9. doi: 10.1007/s12028-009-9281-1.
- Background: PubMed 18166989Harhangi BS, Kompanje EJ, Leebeek FW, Maas AI. Coagulation disorders after traumatic brain injury. Acta Neurochir (Wien). 2008 Feb;150(2):165-75; discussion 175. doi: 10.1007/s00701-007-1475-8. Epub 2008 Jan 2.
- Background: PubMed 23301970Maegele M. Coagulopathy after traumatic brain injury: incidence, pathogenesis, and treatment options. Transfusion. 2013 Jan;53 Suppl 1:28S-37S. doi: 10.1111/trf.12033.
- Background: PubMed 25052157de Oliveira Manoel AL, Neto AC, Veigas PV, Rizoli S. Traumatic brain injury associated coagulopathy. Neurocrit Care. 2015 Feb;22(1):34-44. doi: 10.1007/s12028-014-0026-4.
- Background: PubMed 26179747Brazinova A, Majdan M, Leitgeb J, Trimmel H, Mauritz W; Austrian Working Group on Improvement of Early TBI Care. Factors that may improve outcomes of early traumatic brain injury care: prospective multicenter study in Austria. Scand J Trauma Resusc Emerg Med. 2015 Jul 16;23:53. doi: 10.1186/s13049-015-0133-z.
- Background: PubMed 21942848Schochl H, Solomon C, Traintinger S, Nienaber U, Tacacs-Tolnai A, Windhofer C, Bahrami S, Voelckel W. Thromboelastometric (ROTEM) findings in patients suffering from isolated severe traumatic brain injury. J Neurotrauma. 2011 Oct;28(10):2033-41. doi: 10.1089/neu.2010.1744. Epub 2011 Sep 23.
- Derived from this study: PubMed 36471184Rimaitis M, Cechanoviciute V, Bilskiene D, Balciuniene N, Vilcinis R, Rimaitis K, Macas A. Dynamic Changes of Hemostasis in Patients with Traumatic Brain Injury Undergoing Craniotomy: Association with in-Hospital Mortality. Neurocrit Care. 2023 Jun;38(3):714-725. doi: 10.1007/s12028-022-01639-4. Epub 2022 Dec 5.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thromboelastometry-guided haemostatic treatment in people with Coagulation Disorder and Brain Injuries, Traumatic, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
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 3 inclusion and 5 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 6 Apr 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 Lithuania. 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?
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?
Mortality (time frame: 30 days). 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 NCT03616808, which also lists 7 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 6 Apr 2021.