2007
DOI: 10.1016/j.annemergmed.2006.07.932
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ProTECT: A Randomized Clinical Trial of Progesterone for Acute Traumatic Brain Injury

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Cited by 528 publications
(420 citation statements)
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“…Also, moderate to good clinical outcome with improved GOS-E scores were observed in patients with moderate TBI (initial GCS 9 -12), but no differences were observed between progesterone treatment and placebo groups for patients with severe TBI. 75 In another clinical study in 159 patients with acute severe TBI (initial GCS Ͻ 8), treatment with progesterone significantly improved neurological outcome at 6 months. 76 A phase III clinical study with progesterone in TBI patients is under way (http://www.Clinicaltrials.gov Identifier: NCT00822900).…”
Section: Clinical Studiesmentioning
confidence: 95%
“…Also, moderate to good clinical outcome with improved GOS-E scores were observed in patients with moderate TBI (initial GCS 9 -12), but no differences were observed between progesterone treatment and placebo groups for patients with severe TBI. 75 In another clinical study in 159 patients with acute severe TBI (initial GCS Ͻ 8), treatment with progesterone significantly improved neurological outcome at 6 months. 76 A phase III clinical study with progesterone in TBI patients is under way (http://www.Clinicaltrials.gov Identifier: NCT00822900).…”
Section: Clinical Studiesmentioning
confidence: 95%
“…In addition to the neuroprotective effects in experimental TBI, clinical studies suggest that pharmacological dosing of progesterone can improve neurological outcomes after TBI. 48 However, progesterone effects on other hormones and/or aromatase activity have not been conducted. Further, the role of estradiol treatment in the TBI population is still unknown.…”
Section: Garringer Et Almentioning
confidence: 99%
“…26 Preliminary clinical data obtained with the use of various progesterone formulations and routes of delivery, combined with experimental data showing adequate brain penetration, provided initial support for a neuroprotective role of progesterone in TBI. The initial PROTECT trial 13 recruited 100 patients from a single site who had a GCS score of 4 to 12. Treatment was initiated within 11 hours after injury, with a 72-hour treatment duration, and was associated with a reduction in the rate of death from any cause, as compared with placebo (13.0% vs. 30.4%; relative risk, 0.43; 95% CI, 0.18 to 0.99).…”
Section: Adverse Eventsmentioning
confidence: 99%
“…12 In addition, two phase 2 randomized, controlled clinical trials with progesterone showed a clinical benefit. 13,14 On the basis of these collective data, two phase 3 trials were initiated at around the same time: the Study of a Neuroprotective Agent, Progesterone, in Severe Traumatic Brain Injury (SYNAPSE) and the Progesterone for the Treatment of Traumatic Brain Injury (PROTECT III) trial. 15 SYNAPSE, a trial sponsored by BHR Pharma, was designed to investigate the clinical effectiveness of progesterone, provided in a 6% soybeanoil emulsion as a ready-to-use formulation, under well-controlled conditions.…”
mentioning
confidence: 99%