SCISSOR—Spinal Cord Injury Study on Small molecule-derived Rho inhibition: a clinical study protocol
Kopp MA, Liebscher T, Watzlawick R, Martus P, Laufer S, Blex C, Schindler R, Jungehulsing GJ, Knüppel S, Kreutzträger M, Ekkernkamp A, Dirnagl U, Strittmatter SM, Niedeggen A, Schwab JM. SCISSOR—Spinal Cord Injury Study on Small molecule-derived Rho inhibition: a clinical study protocol. BMJ Open 2016, 6: e010651. PMID: 27466236, PMCID: PMC4964175, DOI: 10.1136/bmjopen-2015-010651.Peer-Reviewed Original ResearchConceptsSpinal cord injurySystemic inflammatory response syndromeNeuropathic painHeterotopic ossificationMotor complete spinal cord injuryPrimary safety end pointEnd pointOpen-label pilot trialImproved motor recoveryPrimary safety analysisSafety end pointSecondary end pointsSerious adverse eventsSevere gastrointestinal bleedingInflammatory response syndromeSecondary outcome assessmentsWarrants clinical investigationAnti-inflammatory drugsClinical study protocolClinical trial protocolGood clinical practiceRho inhibitionDeclaration of HelsinkiGastroduodenal bleedingGastrointestinal bleeding