Influence of brain tissue pH regulation on cerebral oxygenation and metabolism in patients with severe traumatic brain injury. - Effect of pH optimisation on cerebral metabolism in head injury

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-000534-20-GB

Enrollment

Registered

2005-02-25

Start date

2005-03-15

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe traumatic brain injury

Interventions

Trade Name: Addex-THAM Product Name: Addex-THAM Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Trometamol, 2-AMINO-2-(H

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: a) patients with head injury requiring ventilation and intracranial pressure monitoring b) abnormal brain tissue pH ( =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: a) patients 7.5 and high plasma osmolarity >340mOsm/L h) pregnancy

Design outcomes

Primary

Measure	Time frame
Secondary Objective: To record clinical outcome of patients, including neuropsychological assessment at 6-9 months after head injury.;Main Objective: This is a small pilot study set to prove the hypothesis that optimisation of abnormal brain tissue pH (correction of brain tissue acidosis) following severe head injury will lead to improvement of cerebral blood flow and metabolism. The latter will be assessed with the use of clinical multimodality monitoring and imaging (cerebral tissiue oxygen, carbon dioxyde and pH sensor, intracranial pressure monitor, transcranial doppler, cerebral microdialysis, PET scan).; Primary end point(s): Primary endpoint - change in cerebral monitoring parameters after THAM infusion: brain tissue gases and cerebral oxygenation (pO2, pCO2 and SjO2), brain tissue biochemistry (markers of tissue ischaemia - lactate, pyruvate, lactate/pyruvate ratio and cell damage - glycerol), cerebral blood flow and volume (PET, TCD); ICP, CPP and cerebral autoregulation.	—

Measure

Time frame

Secondary Objective: To record clinical outcome of patients, including neuropsychological assessment at 6-9 months after head injury.;Main Objective: This is a small pilot study set to prove the hypothesis that optimisation of abnormal brain tissue pH (correction of brain tissue acidosis) following severe head injury will lead to improvement of cerebral blood flow and metabolism. The latter will be assessed with the use of clinical multimodality monitoring and imaging (cerebral tissiue oxygen, carbon dioxyde and pH sensor, intracranial pressure monitor, transcranial doppler, cerebral microdialysis, PET scan).; Primary end point(s): Primary endpoint - change in cerebral monitoring parameters after THAM infusion: brain tissue gases and cerebral oxygenation (pO2, pCO2 and SjO2), brain tissue biochemistry (markers of tissue ischaemia - lactate, pyruvate, lactate/pyruvate ratio and cell damage - glycerol), cerebral blood flow and volume (PET, TCD); ICP, CPP and cerebral autoregulation.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026