Hier finden Sie international veröffentlichte Publikationen der Mitarbeiter des KKS Heidelberg:

Rationale and design of the German-Speaking Myeloma Multicenter Group (GMMG) trial ReLApsE: a randomized, open, multicenter phase III trial of lenalidomide/dexamethasone versus lenalidomide/dexamethasone plus subsequent autologous stem cell transplantation and lenalidomide maintenance in patients with relapsed multiple myeloma
Marc-Andrea Baertsch, Jana Schlenzka, Elias K. Mai, Maximilia Merz, Jens Hillengaß, Marc S. Raab, Dirk hose, Patrick Wuchter, Anthony D. Ho, Anna Jauch, Thomas Hielscher, Christina Kunz, Steffen Luntz, Stefan Klein, Ingo G. H. Schmidt-Wolf, Martin Goerner, Martin Schmidt-Hieber, Peter Reimer, Ullrich Graeven, Roland Fenk, Hans Salwender, Christof, Scheid, Axel Nogai, Mathias Haenel, Hans W. Lindemann, Hans Martin, Richard Noppeney, Katja Weisel and Hartmut Goldschmidt

Therapie der dislozierten intraartikulären distalen Radiusfraktur des älteren Patienten
Randomisierte Multicenterstudie (ORCHID) zur offenen Reposition und volaren Plattenosteosynthese versus geschlossener Reposition und Gipsimmobilisierung
Christoph Bartl, Dirk Stengel, Thomas Bruckner, Florian Gebhard und die ORCHID-Studiengruppe
Deutsches Ärzteblatt Dez. 2014

Klinische Studien: Nutzen und Risiken
Steffen P. Luntz
Apotheken Umschau 2014/09

Hemicraniectomy in Older Patients with Extensive Middle-Cerebral-Artery Stroke.
Eric Jüttler, M.D., Ph.D., Andreas Unterberg, M.D., Ph.D., Johannes Woitzik, M.D., Ph.D., Julian Bösel, M.D., Hemasse Amiri, M.D., Oliver W. Sakowitz, M.D., Ph.D., Matthias Gondan, Ph.D., Petra Schiller, Ph.D., Ronald Limprecht, Steffen Luntz, M.D., Hauke Schneider, M.D., Ph.D., Thomas Pinzer, M.D., Ph.D., Carsten Hobohm, M.D., Jürgen Meixensberger, M.D., Ph.D., and Werner Hacke, M.D., Ph.D., for the DESTINY II Investigators
The new england journal of medicine March 2014, Vol. 370, No12, Pages 1091-1100.

Long-term outcome of psychodynamic therapy and cognitive-behavioral therapy in social anxiety disorder.
Leichsenring F, Salzer S, Beutel ME, Herpertz S, Hiller W, Hoyer J, Huesing J, Joraschky P, Nolting B, Poehlmann K, Ritter V, Stangier U, Strauss B, Tefikow S, Teismann T, Willutzki U, Wiltink J, Leibing E.
Am J Psychiatry. 2014 Oct;171(10):1074-82. doi: 10.1176/appi.ajp.2014.13111514.

Psychodynamic therapy and cognitive-behavioral therapy in social anxiety disorder: a multicenter randomized controlled trial.
Leichsenring F, Salzer S, Beutel ME, Herpertz S, Hiller W, Hoyer J, Huesing J, Joraschky P, Nolting B, Poehlmann K, Ritter V, Stangier U, Strauss B, Stuhldreher N, Tefikow S, Teismann T, Willutzki U, Wiltink J, Leibing E.
Am J Psychiatry. 2013 Jul;170(7):759-67. doi: 10.1176/appi.ajp.2013.12081125. Erratum in: Am J Psychiatry. 2013 Nov 1;170(11):1373.

GCP-compliant digital archiving of paper-based patient records of clinical trial subjects: a key issues paper.
Kohl CD, Bruns I, Freudigmann M, Scharf G, Schmücker P, Schwarz G, Semler SC.
Clinical Investigation, May 2013, Vol. 3, No. 5, Pages 451-465.

Digitale Archivierung papierbasierter Krankenakten von Studienpatienten – Eckpunktepapier des KKSN, der GMDS und der TMF unter Mitwirkung des BfArM und der Landesüberwachungsbehörde Nordrhein-Westfalen.
Kohl CD, Bruns I, Freudigmann M, Scharf G, Schmücker P, Schwarz G, Semler SC.
GMS Med Inform Biom Epidemiol. 2013;9(3):Doc10. DOI: 10.3205/mibe000138, URN: urn:nbn:de:0183-mibe0001389

HAnd Suture Versus STApling for Closure of Loop Ileostomy (HASTA Trial): results of a multicenter randomized trial (DRKS00000040).
Löffler T, Rossion I, Bruckner T, Diener MK, Koch M, von Frankenberg M, Pochhammer J, Thomusch O, Kijak T, Simon T, Mihaljevic AL, Krüger M, Stein E, Prechtl G, Hodina R, Michal W, Strunk R, Henkel K, Bunse J, Jaschke G, Politt D, Heistermann HP, Fußer M, Lange C, Stamm A, Vosschulte A, Holzer R, Partecke LI, Burdzik E, Hug HM, Luntz SP, Kieser M, Büchler MW, Weitz J; HASTA Trial Group.
Ann Surg. 2012 Nov;256(5):828-35; discussion 835-6. doi: 10.1097/SLA.0b013e318272df97. Erratum in: Ann Surg. 2013 Mar;257(3):577.

Design of a prospective clinical study on the agreement between the Continuous GlucoseMonitor, a novel device for CONTinuous ASSessment of blood GLUcose levels, and the RAPIDLab® 1265 blood gas analyser: The CONTASSGLU study.
Zimmermann JB, Lehmann M, Hofer S, Hüsing J, Alles C, Werner J, Stiller J, Künnecke W, Luntz S, Motsch J, Weigand MA.
BMC Anesthesiol. 2012 Sep 22;12:24. doi: 10.1186/1471-2253-12-24.

DeloRes trial: study protocol for a randomized trial comparing two standardized surgical approaches in rectal prolapse - Delorme's procedure versus resection rectopexy.
Roethenhoefer S, Herrle F, Herold A, Joos A, Bussen D, Kieser M, Schiller P, Klose C, Seiler C, Kienle P, Post S
Trials. 2012 Aug 29;13(1):155. [Epub ahead of print]

Resection of the primary tumour versus no resection prior to systemic therapy in patients with colon cancer and synchronous unresectable metastases (UICC stage IV): SYNCHRONOUS - A randomised controlled multicentre trial (ISRCTN30964555).
Rahbari NN, Lordick F, Fink C, Bork U, Stange A, Jager D, Luntz SP, Englert S, Rossion I, Koch M, Buchler MW, Kieser M, Weitz J.
BMC Cancer. 2012 Apr 5;12(1):142

Versorgungsnahe klinische Studien nach der Zulassung
Steffen P. Luntz
Zeitschrift für Evidenz, fortbildung und Qualität im Gesundheitswesen, 2011 Nov

Efficacy of stapler versus hand-sewn closure after distal pancreatectomy (DISPACT): a randomised, controlled multicentre trial.
Diener MK, Seiler CM, Rossion I, Kleeff J, Glanemann M, Butturini G, Tomazic A, Bruns CJ, Busch OR, Farkas S, Belyaev O, Neoptolemos JP, Halloran C, Keck T, Niedergethmann M, Gellert K, Witzigmann H, Kollmar O, Langer P, Steger U, Neudecker J, Berrevoet F, Ganzera S, Heiss MM, Luntz SP, Bruckner T, Kieser M, Büchler MW.
Lancet. 2011 Apr 30; 337(9776): 1514-22 

Open reduction and internal fixation versus casting for highly comminuted and intra-articular fractures of the distal radius (ORCHID): protocol for a randomized clinical multi-center trial 
Christoph Bartl, Dirk Stengel, Thomas Bruckner, Inga Rossion, Steffen Luntz, Christoph Seiler, Florian Gebhard
Trials 2011 March 22

Hand-suture versus stapling for closure of loop ileostomy: HASTA-Trial: a study rationale and design for a randomized controlled trial.
Löffler T, Seiler CM, Rossion I, Kijak T, Thomusch O, Hodina R, Krüger M, Simon T, Bruckner T, Kieser M, Büchler MW, Weitz J; HASTA Trial Group.
Trials. 2011 Feb 8;12:34. doi: 10.1186/1745-6215-12-34.

Steffen P. Luntz, Britta Schröder
Medizinprodukte planen, entwickeln und realisieren: Klinische Prüfungen - Planung und Durchführung
TÜV Media GmbH, Köln (2010, ISBN 9783824912360)

Steffen P. Luntz,  Britta Schröder
Augsburger Schriften zum Arzneimittel- und Medizinprodukterecht: Planung und Organisation klinischer Studien mit Medizinprodukten
Shaker Verlag, Aachen (2009, ISBN 9783832282707)

A randomized, controlled, prospective trial to evaluate the haemostatic effect of Lyostypt versus Surgicel in arterial bypass anastomosis: "COBBANA" trial
Petra Baumann, Hardy Schuhmacher, Johannes Hüsing, Stefffen Luntz, Hanns-Peter Knaebel
Trials 2009 Sept 29, 10:91

Radiobeitrag zum KKS Heidelberg
SWR4 Kurpfalz Radio, 15.07.2009, 12:45 h

Luntz SP, Gorbauch T, Schröder B, Seibert-Grafe M
Aufgaben der Koordinierungszentren für Klinische Studien
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz; 2009 Apr;52(4):444-50

DISPACT: A randomized controlled trial to compare two different surgical techniques of Distal Pancreatectomy: Study rationale and design (ISRCTN 18452029)
Diener MK, Knaebel HP, Witte St, Büchler MW, Seiler CM and the DISPACT Trial Group (2007)
Clinical Trials 2008; 5; 534

Protocol for German trial of Acyclovir and corticosteroids in Herpes-simplex-virus-encephalitis (GACHE): a multicenter, multinational, randomized, double-blind, placebo-controlled German, Austrian and Dutch trial [ISRCTN45122933]
Martinez-Torres F, Menon S, Victor N, Jenetzky E, Jensen K, Schielke E, Schmutzhard E, de Gans J, Chung CH, Luntz S, Hacke W, Meyding-Lamadé U; GACHE Investigators
BMC Neurol. 2008 Oct 29, 8:40

A historically controlled, single-arm, multi-centre, prospective trial to evaluate the safety and efficacy of MonoMax suture material for abdominal wall closure after primary midline laparotomy. ISSAAC-Trial [NCT005725079]
Fischer L, Baumann P, Hüsing J, Seidlmayer C, Albertsmeier M, Franck A, Luntz S, Seiler CM, Knaebel HP
BMC Surg. 2008 Jul 21; 8:21

K. Krockenberger, S.P. Luntz, P.Knaup
Usage and Usability of Standard Operating Procedures (SOP) among the Coordination Centers for Clinical Trials (KKS)
Methods of Information in Medicine, 2008 47 6:505-510

Peritonitis in children who receive long-term peritoneal dialysis: a prospective evaluation of therapeutic guidelines
Warady BA, Feneberg R, Verrina E, Flynn JT, Müller-Wiefel DE, Besbas N, Zurowska A, Aksu N, Fischbach M, Sojo E, Donmez O, Sever L, Sirin A, Alexander SR, Schaefer F; IPPR.
J Am Soc Nephrol. 2007 Jul;18(7):2172-9

Aim, content, evaluation and perspectives of surgical training in randomized trials at the Study Centre of the German Surgical Society
Veit J, Knaebel HP, Franck A, Luntz St P, Seiler CM (2006)
Chirurg. 2006 Aug;77(8):725-8. German.

CRASH2 in Germany
Chung CH, Freiberger A, Kalkum M, Luntz SP, Shakur H, Seiler CM. [ISRCTN 86750102].
Trials. 2006 Jun 21;7:22 

Comparison of Venae Sectio vs. modified Seldinger Technique for Totally Implantable Access Ports; Portas-trial
Knebel P, Frohlich B, Knaebel HP, Kienle P, Luntz S, Buchler M, Seiler C. (2006) [ISRCTN:52368201].
Trials. 2006 Jun 8;7:20

Kinetics and dynamics of the peripheral neurokinin-1 receptor antagonist SLV317 in healthy individuals
Hesse C, Luntz SP, Siedler H, Unnebrink K, Mikus G, de Bruijn M, Zondag E, de Vries M, Seibert-Grafe M, Haefeli WE
BR J Clin Pharmacol. 2006 Apr;61(4):414-9

Modulation of endothelial and smooth muscle function by bed rest and hypoenergetic, low-fat nutrition
Hesse C, Siedler H, Luntz SP, Arendt BM, Goerlich R, Fricker R, Heer M, Haefeli WE
J Appl Physiol. 2005 Dec;99(6):2196-203

HEGPOL: randomized, placebo controlled, multicenter, double-blind clinical trial to investigate hepatoprotective effects of glycine in the postoperative phase of liver transplantation [ISRCTN69350312]
Luntz SP, Unnebrink K, Seibert-Grafe M, Bunzendahl H, Kraus TW, Büchler MW, Klar E, Schemmer P.
BMC Surg. 2005 Aug 17;5:18​​​​​​​