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| Name | Class |
|---|---|
| Swiss National Science Foundation | OTHER |
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Novel, non-vitamin K antagonist oral anticoagulants (NOAC) target selected players in the coagulation cascade as the direct thrombin inhibitor dabigatran and the factor Xa-inhibitors apixaban and rivaroxaban. Intracerebral hemorrhage (ICH) is the most feared complication of NOAC treatment (NOAC-ICH).
Outcome of NOAC-ICH can be devastating and is a major cause of death and disability. There is no proven treatment for NOAC-ICH. Hematoma expansion (HE) is associated with unfavorable outcome. Tranexamic acid (TA) is an anti-fibrinolytic drug that is used in a number of bleeding conditions other than ICH.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tranexamic acid | Experimental | Intravenous tranexamic acid: 1g loading dose given as 100 mls infusion over 10 minutes, followed by another 1g in 250 mls infused over 8 hours. |
|
| Placebo | Placebo Comparator | Saline 0.9% given in identical dosage as experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic acid | Drug | intravenous |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Hematoma expansion | Change in ICH-volume between baseline CT and follow-up-CT at 24 ± 3 hours of 33% relative or 6ml absolute increase | up to 27 hours |
| Measure | Description | Time Frame |
|---|---|---|
| modified Rankin Scale (mRS) 0-4 at month 3; | 3 months | |
| mRS 0-3 at month 3; | 3 months | |
| Categorical shift in mRS at month 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philippe Lyrer, MD | Stroke Center and Neurology, University Hospital Basel | Study Chair |
| Stefan Engelter, MD | Stroke Center and Neurology, University Hospital Basel | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stroke Center, University Hospital Basel | Basel | 4031 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38264861 | Derived | Siepen BM, Polymeris A, Shoamanesh A, Connolly S, Steiner T, Poli S, Lemmens R, Goeldlin MB, Muller M, Branca M, Rauch J, Meinel T, Kaesmacher J, Z'Graggen W, Arnold M, Fischer U, Peters N, Engelter ST, Lyrer P, Seiffge D. Andexanet alfa versus non-specific treatments for intracerebral hemorrhage in patients taking factor Xa inhibitors - Individual patient data analysis of ANNEXA-4 and TICH-NOAC. Int J Stroke. 2024 Jun;19(5):506-514. doi: 10.1177/17474930241230209. Epub 2024 Mar 8. | |
| 37870112 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 16, 2020 | Mar 22, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002543 | Cerebral Hemorrhage |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Saline 0.9% | Drug | intravenous |
|
| 3 months |
| mortality due to any cause at month 3 | 3 months |
| In-hospital mortality | baseline until discharge from hospital (stay at hospital lasts on an average of 10 days) |
| Absolute ICH growth volume by 24 ± 3 hours, adjusted for baseline ICH volume | up to 27 hours |
| Symptomatic HE defined as HE and additionally a neurological deterioration of NIHSS >4 points or Glasgow Coma Scale (GCS) >2 points | up to 27 hours |
| number of major thromboembolic events (myocardial infarction, ischemic stroke, pulmonary embolism - safety endpoints) | 3 months |
| number of neurosurgical interventions (including craniectomy, external ventricular drain (EVD), hematoma evacuation) | 3 months |
| Derived |
| Eilertsen H, Menon CS, Law ZK, Chen C, Bath PM, Steiner T, Desborough MJ, Sandset EC, Sprigg N, Al-Shahi Salman R. Haemostatic therapies for stroke due to acute, spontaneous intracerebral haemorrhage. Cochrane Database Syst Rev. 2023 Oct 23;10(10):CD005951. doi: 10.1002/14651858.CD005951.pub5. |
| 37466000 | Derived | Polymeris AA, Karwacki GM, Siepen BM, Schaedelin S, Tsakiris DA, Stippich C, Guzman R, Nickel CH, Sprigg N, Kagi G, Vehoff J, Barinka F, Thilemann S, Maurer M, Wagner B, Traenka C, Gensicke H, De Marchis GM, Bonati LH, Fischer U, Z'Graggen WJ, Nedeltchev K, Wegener S, Baumgartner P, Engelter ST, Seiffge DJ, Peters N, Lyrer PA; TICH-NOAC Investigators. Tranexamic Acid for Intracerebral Hemorrhage in Patients on Non-Vitamin K Antagonist Oral Anticoagulants (TICH-NOAC): A Multicenter, Randomized, Placebo-Controlled, Phase 2 Trial. Stroke. 2023 Sep;54(9):2223-2234. doi: 10.1161/STROKEAHA.123.042866. Epub 2023 Jul 19. |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002712 |
| Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |