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NCT03616808: THROMBIN
Thromboelastometry-identified Haemostatic Changes in Isolated Traumatic Brain Injury
NA trial testing Thromboelastometry-guided haemostatic treatment in Coagulation Disorder in 142 participants. Completed in 31 December 2020.
30 August 2020
Quick facts
| Lead sponsor | Lithuanian University of Health Sciences |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 142 |
| Start date | 21 August 2018 |
| Primary completion | 30 August 2020 |
| Estimated completion | 31 December 2020 |
| Sites | 1 location across Lithuania |
Drugs / interventions tested
- Thromboelastometry-guided haemostatic treatment
Conditions studied
- Coagulation Disorder — all drugs for Coagulation Disorder →
- Brain Injuries, Traumatic — all drugs for Brain Injuries, Traumatic →
- Bleeding — all drugs for Bleeding →
Sponsor
Lithuanian University of Health Sciences
Who can join
18 and older, any sex, with Coagulation Disorder or Brain Injuries, Traumatic. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03616808
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Other Lithuanian University of Health Sciences trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03616808 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Lithuanian University of Health Sciences
- Last refreshed: 6 April 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03616808.
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