| N | Study Years | Publication plus year | |
| TCDB | 746 | 1984-1987 | Foulkes et al. 1991 |
| EBIC core data study* | 847 | 1995 | Murray et al. 1999 |
| UK 4 | 988 | 1986-1988 | Murray et al. 1999 |
| Total: | 2581 |
| N | Study Years | Publication plus year | |
| HIT I Nimodipine | 351 | 1987-1989 | Bailey et al. 1991 |
| HIT II Nimodipine | 852 | 1989-1991 | EUR Study Group 1994 |
| Tirilazad trials (2)* | 2269 | 1991-1994 | Marshall et al. 1998 |
| Saphir | 924 | 1995-1997 | - |
| International Selfotel trial | 409 | 1994-1996 | Morris et al. 1999 |
| PEGSOD | 1574 | 1993-1995 | Young et al. 1996** |
| SKB | 139 | 1996 | Marmarou et al. 1999 |
| Total: | 6518 |
| N | Description | |
|
APOE 1996-1999 Teasdale et al. 2005 |
351 |
This cohort study investigated the relation between ApoE genotype and
outcome across all injury severities, includes many patients with mild
injuries, accurate details on treatment and 8-point GOSE. |
|
NABIS hypothermia 1994-1998 Clifton et al. 2001 |
392 |
We had originally planned to include this dataset in the current grant
period, but received the full dataset too late to include in IMPACT I.
Considerable center effects and variations in patient management have
been reported for this dataset. |
|
CERESTAT 1996-1997 |
532 |
Is an unpublished RCT investigating the effect of Aptiganel HCl, a non
competitive NMDA blocker in severe TBI. |
|
The Pharmos Dexanabiol Trial 2001-2004 Maas et al. 2006 |
861 |
Investigated safety and efficacy of dexanabinol, and is the most recent
conventional Phase III trial in TBI. Dexanabinol is a non-psychotropic
cannibinoid agonist with demonstrated neuroprotection in preclinical studies.
Both the Principal Investigator and Professor Gordon Murray are well acquainted
with this study as they have been closely involved in the design and analysis
of the trial (Maas et al 2006). The Pharmos study includes extensive data on
patient management and outcome assessed by the 8 -point GOSE together with
Quality of Life scores (SF 36 and CIQ). |
| N | Description | |
|
CRASH 1999-2004 Edwards et al. 2005 Roberts et al. 2004 |
10008 |
Aimed to resolve the uncertainty concerning the use of steroids in TBI
and represents the only mega trial conducted in the field of TBI. The
dataset is typical of a mega trial with large numbers, limited information
and simple outcome assessment. The CRASH investigators recruited 10008
patients in 239 centers from 49 countries. We greatly appreciate the
permission granted by the CRASH management group to provide us with the
raw data and consider it especially relevant to include this study in
the IMPACT dataset because it contains a large number of patients with
mild injury and allows us to evaluate the relative merits of a mega
trial based on actual data rather than simulations studies. |
|
TARN-TBI 1989- ongoing Patel et al. 2005 |
22000 |
TARN represents a large dataset of the Trauma Audit and Research Network,
and includes over 22000 patients with TBI. Although it is not a clinical
trial, the methodology of data collection (large numbers, simple data) is
very similar to that which would be applied in a mega trial. We therefore
consider it an asset to include the TARN data on TBI within our analysis,
particularly in specific aim 4. |
* These studies also included patients with moderate head injury. The number of patients with severe TBI in the EBIC Core data study was: 551 and in the Tirilazad trials: 1783.
** Publication refers to first trial.