Last reviewed · How we verify
NCT01886222: LTH-Ⅰ
Randomized Controlled Trial of Long-term Mild Hypothermia for Severe Traumatic Brain Injury
NA trial testing Long-term mild hypothermia in Brain Injuries in 312 participants. Completed in 30 June 2019.
30 June 2019
Quick facts
| Lead sponsor | RenJi Hospital |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 312 |
| Start date | 12 November 2013 |
| Primary completion | 30 June 2019 |
| Estimated completion | 30 June 2019 |
| Sites | 1 location across China |
Drugs / interventions tested
- Long-term mild hypothermia
- Normothermia
Conditions studied
- Brain Injuries — all drugs for Brain Injuries →
- Craniocerebral Trauma — all drugs for Craniocerebral Trauma →
Sponsor
RenJi Hospital
Who can join
Adults 18 to 65, any sex, with Brain Injuries or Craniocerebral Trauma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is a prospective multi-centre randomized trial to compare the effect of long-term mild hypothermia versus routine normothermic intensive management in patients with severe traumatic brain injury. The primary hypothesis is that the induction of mild hypothermia (maintained at 34-35℃) for 5 days will improve the outcome of patients at six months post injury compared with normothermia.
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 NCT01886222
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Brain Injuries
Currently open trials in the same condition.
- NCT06607523 — The Gut-Brain Axis During Neurorehabilitation; Prebiotic Treatment to Alter the Gut Microbiome and Neurologic Symptoms · NA · recruiting
- NCT06873477 — Evaluation of Patients Affected by Traumatic and Hypoxic-ischemic Brain Injury · recruiting
- NCT06511804 — Correlation Between Noninvasive Blood Vessel Functionality Parameters and Cerebral Hemodynamics in Neurocritical Care Pa · recruiting
- NCT06863025 — Effects of Neurofeedback Training on Attentional Deficits in Patients With Acquired Brain Injury · NA · active not recruiting
- NCT06571032 — Electroencephalography in the Management of Neuroelectric Stimulation in Patients With Severe Traumatic Brain Injuries · recruiting
Other RenJi Hospital trials
Trials by the same sponsor.
- NCT07584733 — Biomarker-Enriched Kidney-Preserving Strategy With Disitamab Vedotin Plus Tislelizumab in HER2-Positive High-Risk Upper · Phase 2 · not yet recruiting
- NCT07537725 — EEG-TMS for Postoperative Delirium After Cardiac Surgery · NA · not yet recruiting
- NCT07527936 — A Study of BEN301 Injection in theTreatment of Autoimmune Diseases · EARLY_PHASE1 · not yet recruiting
- NCT07343076 — Efficacy of Immediate Versus Staged Complete Revascularization in Patients With NSTE-ACS and Multivessel Disease (FUTURE · NA · not yet recruiting
- NCT07449793 — Biochemical Response and Clinical Outcomes in Patients With PBC · recruiting
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 NCT01886222 (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 RenJi Hospital
- Last refreshed: 12 March 2020
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/NCT01886222.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing