Thromboelastometry-identified Haemostatic Changes in Isolated Traumatic Brain Injury

NCT03616808 | Completed

• 1 other identifier: V2
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Coagulation Disorder; Brain Injuries, Traumatic; Bleeding

Keywords

Traumatic brain injury; Craniotomy; Goal-directed treatment; Thromboelastometry

Outcome Measures

Primary Outcomes (2)

• Mortality

  Mortality of patients in both groups

  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).

  30 days

Secondary Outcomes (3)

• Coagulation abnormalities on conventional coagulation assays and ROTEM

  72 hours

• Progressive hemorrhagic injury

  30 days

• Clinical outcome according to Glasgow outcome score

  Up to 1 year

Other Outcomes (1)

• Correlation between conventional coagulation assays and ROTEM parameters

  72 hours

Study Arms (2)

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.

Other: Thromboelastometry-guided haemostatic treatment

Interventions

Thromboelastometry-guided haemostatic treatment OTHER

Administration of blood products and/or procoagulants is based on thromboelastometric assays.

Goal-directed therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lithuanian University of Health Sciences: lead

Study Sites (1)

Hospital of Lithuanian University of Health Sciences

Kaunas, LT-50009, Lithuania

Location

Related Publications (7)

• 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.

  PMID: 19806475 BACKGROUND

• Harhangi 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.

  PMID: 18166989 BACKGROUND

• Maegele M. Coagulopathy after traumatic brain injury: incidence, pathogenesis, and treatment options. Transfusion. 2013 Jan;53 Suppl 1:28S-37S. doi: 10.1111/trf.12033.

  PMID: 23301970 BACKGROUND

• de 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.

  PMID: 25052157 BACKGROUND

• Brazinova 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.

  PMID: 26179747 BACKGROUND

• Schochl 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.

  PMID: 21942848 BACKGROUND

• Rimaitis 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.

  PMID: 36471184 DERIVED

MeSH Terms

Conditions

Hemostatic Disorders; Brain Injuries, Traumatic; Hemorrhage

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Model Details: A case-control study. Conventional management patients are considered as "controls" whereas goal-directed management patients will be considered "cases".

Study Record Dates

• First Submitted: July 13, 2018
• First Posted: August 6, 2018
• Study Start: August 21, 2018
• Primary Completion: August 30, 2020
• Study Completion: December 31, 2020
• Last Updated: April 6, 2021

Record last verified: 2021-04

Locations

LI (1)