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1. Endovascular treatment versus no endovascular treatment after 6-24 h in patients with ischaemic stroke and collateral flow on CT angiography (MR CLEAN-LATE) in the Netherlands: a multicentre, open-label, blinded-endpoint, randomised, controlled, phase 3 trial.

Author

Olthuis, S.G.H., Pirson, F.A.V., Pinckaers, F.M.E., Hinsenveld, W.H., Nieboer, D., Ceulemans, A., Knapen, R.R.M.M., Robbe, M.M.Q., Berkhemer, O.A., Walderveen, Marianne A.A. van, Lycklama a Nijeholt, G.J., Uyttenboogaart, M., Schonewille, W.J., Sluijs, P.M. van der, Wolff, L., Voorst, H. van, Postma, A.A., Roosendaal, S.D., Hoorn, A. van der, Emmer, B.J., Krietemeijer, M.G.M., Doormaal, P.J. van, Roozenbeek, B., Goldhoorn, R.B., Staals, J., Ridder, I.R. de, Leij, C. van der, Coutinho, J.M., Worp, H.B. van der, Lo, R.T., Bokkers, R.P., Dijk, E.J. van, Boogaarts, H.D., Wermer, M.J., Es, A.C. van, Tuijl, J.H. van, Kortman, H.G., Gons, R.A., Yo, L.S., Vos, J.A., Laat, K.F. de, Dijk, L.C. van, Wijngaard, I.R. van den, Hofmeijer, J., Martens, J.M., Brouwers, P.J., Bulut, T., Remmers, M.J., Jong, T.E.A.M. de, Hertog, H.M. den, Hasselt, B.A. van, Rozeman, A.D., Elgersma, O.E.H., Veen, B. van der, Sudiono, D.R., Lingsma, H.F., Roos, Y.B.W.E.M., Majoie, C.B.L.M., Lugt, A. van der, Dippel, D.W., Zwam, W.H. van, Oostenbrugge, R.J. van, Olthuis, S.G.H., Pirson, F.A.V., Pinckaers, F.M.E., Hinsenveld, W.H., Nieboer, D., Ceulemans, A., Knapen, R.R.M.M., Robbe, M.M.Q., Berkhemer, O.A., Walderveen, Marianne A.A. van, Lycklama a Nijeholt, G.J., Uyttenboogaart, M., Schonewille, W.J., Sluijs, P.M. van der, Wolff, L., Voorst, H. van, Postma, A.A., Roosendaal, S.D., Hoorn, A. van der, Emmer, B.J., Krietemeijer, M.G.M., Doormaal, P.J. van, Roozenbeek, B., Goldhoorn, R.B., Staals, J., Ridder, I.R. de, Leij, C. van der, Coutinho, J.M., Worp, H.B. van der, Lo, R.T., Bokkers, R.P., Dijk, E.J. van, Boogaarts, H.D., Wermer, M.J., Es, A.C. van, Tuijl, J.H. van, Kortman, H.G., Gons, R.A., Yo, L.S., Vos, J.A., Laat, K.F. de, Dijk, L.C. van, Wijngaard, I.R. van den, Hofmeijer, J., Martens, J.M., Brouwers, P.J., Bulut, T., Remmers, M.J., Jong, T.E.A.M. de, Hertog, H.M. den, Hasselt, B.A. van, Rozeman, A.D., Elgersma, O.E.H., Veen, B. van der, Sudiono, D.R., Lingsma, H.F., Roos, Y.B.W.E.M., Majoie, C.B.L.M., Lugt, A. van der, Dippel, D.W., Zwam, W.H. van, and Oostenbrugge, R.J. van

Abstract

Item does not contain fulltext, BACKGROUND: Endovascular treatment for anterior circulation ischaemic stroke is effective and safe within a 6 h window. MR CLEAN-LATE aimed to assess efficacy and safety of endovascular treatment for patients treated in the late window (6-24 h from symptom onset or last seen well) selected on the basis of the presence of collateral flow on CT angiography (CTA). METHODS: MR CLEAN-LATE was a multicentre, open-label, blinded-endpoint, randomised, controlled, phase 3 trial done in 18 stroke intervention centres in the Netherlands. Patients aged 18 years or older with ischaemic stroke, presenting in the late window with an anterior circulation large-vessel occlusion and collateral flow on CTA, and a neurological deficit score of at least 2 on the National Institutes of Health Stroke Scale were included. Patients who were eligible for late-window endovascular treatment were treated according to national guidelines (based on clinical and perfusion imaging criteria derived from the DAWN and DEFUSE-3 trials) and excluded from MR CLEAN-LATE enrolment. Patients were randomly assigned (1:1) to receive endovascular treatment or no endovascular treatment (control), in addition to best medical treatment. Randomisation was web based, with block sizes ranging from eight to 20, and stratified by centre. The primary outcome was the modified Rankin Scale (mRS) score at 90 days after randomisation. Safety outcomes included all-cause mortality at 90 days after randomisation and symptomatic intracranial haemorrhage. All randomly assigned patients who provided deferred consent or died before consent could be obtained comprised the modified intention-to-treat population, in which the primary and safety outcomes were assessed. Analyses were adjusted for predefined confounders. Treatment effect was estimated with ordinal logistic regression and reported as an adjusted common odds ratio (OR) with a 95% CI. This trial was registered with the ISRCTN, ISRCTN19922220. FINDINGS: Between Feb 2, 2018

Published
2023

2. The Preventive Antibiotics in Stroke Study (PASS): a pragmatic randomised open-label masked endpoint clinical trial

Author

Westendorp, W.F., Vermeij, J.D., Zock, E., Hooijenga, I.J., Kruyt, N.D., Bosboom, H.J., Kwa, V.I.H., Weisfelt, M., Remmers, M.J., Houten, R. ten, Schreuder, A.H., Vermeer, S.E., Dijk, E.J. van, Dippel, D.W., Dijkgraaf, M.G., Spanjaard, L., Vermeulen, M, Poll, T. van der, Prins, J.M., Vermeij, F.H., Roos, Y.B., Kleyweg, R.P., Kerkhoff, H., Brouwer, M.C.T., Zwinderman, A.H., Beek, D. van de, Nederkoorn, P.J., Westendorp, W.F., Vermeij, J.D., Zock, E., Hooijenga, I.J., Kruyt, N.D., Bosboom, H.J., Kwa, V.I.H., Weisfelt, M., Remmers, M.J., Houten, R. ten, Schreuder, A.H., Vermeer, S.E., Dijk, E.J. van, Dippel, D.W., Dijkgraaf, M.G., Spanjaard, L., Vermeulen, M, Poll, T. van der, Prins, J.M., Vermeij, F.H., Roos, Y.B., Kleyweg, R.P., Kerkhoff, H., Brouwer, M.C.T., Zwinderman, A.H., Beek, D. van de, and Nederkoorn, P.J.

Abstract

Item does not contain fulltext, BACKGROUND: In adults with acute stroke, infections occur commonly and are associated with an unfavourable functional outcome. In the Preventive Antibiotics in Stroke Study (PASS) we aimed to establish whether or not preventive antimicrobial therapy with a third-generation cephalosporin, ceftriaxone, improves functional outcome in patients with acute stroke. METHODS: In this multicentre, randomised, open-label trial with masked endpoint assessment, patients with acute stroke were randomly assigned to intravenous ceftriaxone at a dose of 2 g, given every 24 h intravenously for 4 days, in addition to stroke unit care, or standard stroke unit care without preventive antimicrobial therapy; assignments were made within 24 h after symptom onset. The primary endpoint was functional outcome at 3 months, defined according to the modified Rankin Scale and analysed by intention to treat. The primary analysis was by ordinal regression of the primary outcome. Secondary outcomes included death, infection rates, antimicrobial use, and length of hospital stay. Participants and caregivers were aware of treatment allocation but assessors of outcome were masked to group assignment. This trial is registered with controlled-trials.com, number ISRCTN66140176. FINDINGS: Between July 6, 2010, and March 23, 2014, a total of 2550 patients from 30 sites in the Netherlands, including academic and non-academic medical centres, were randomly assigned to the two treatment groups: 1275 patients to ceftriaxone and 1275 patients to standard treatment (control group). 12 patients (seven in the ceftriaxone group and five in the control group) withdrew consent immediately after randomisation, leaving 2538 patients available for the intention-to-treat-analysis (1268 in the ceftriaxone group and 1270 in the control group). 2514 (99%) of 2538 patients (1257 in each group) completed 3-month follow-up. Preventive ceftriaxone did not affect the distribution of functional outcome scores on the modified Rankin

Published
2015

3. Diagnostic yield and accuracy of CT angiography, MR angiography, and digital subtraction angiography for detection of macrovascular causes of intracerebral haemorrhage: prospective, multicentre cohort study

Author

Asch, C.J. van, Velthuis, B.K., Rinkel, G.J., Algra, A., Kort, G.A. de, Witkamp, T.D., Ridder, J.C. de, Nieuwenhuizen, K.M., Leeuw, F.E. de, Schonewille, W.J., Kort, P.L. de, Dippel, D.W., Raaymakers, T.W., Hofmeijer, J., Wermer, M.J., Kerkhoff, H., Jellema, K., Bronner, I.M., Remmers, M.J., Bienfait, H.P., Witjes, R.J., Greving, J.P., Klijn, C.J.M., Asch, C.J. van, Velthuis, B.K., Rinkel, G.J., Algra, A., Kort, G.A. de, Witkamp, T.D., Ridder, J.C. de, Nieuwenhuizen, K.M., Leeuw, F.E. de, Schonewille, W.J., Kort, P.L. de, Dippel, D.W., Raaymakers, T.W., Hofmeijer, J., Wermer, M.J., Kerkhoff, H., Jellema, K., Bronner, I.M., Remmers, M.J., Bienfait, H.P., Witjes, R.J., Greving, J.P., and Klijn, C.J.M.

Abstract

Contains fulltext : 152122.pdf (Publisher’s version ) (Open Access), STUDY QUESTION: What are the diagnostic yield and accuracy of early computed tomography (CT) angiography followed by magnetic resonance imaging/angiography (MRI/MRA) and digital subtraction angiography (DSA) in patients with non-traumatic intracerebral haemorrhage? METHODS: This prospective diagnostic study enrolled 298 adults (18-70 years) treated in 22 hospitals in the Netherlands over six years. CT angiography was performed within seven days of haemorrhage. If the result was negative, MRI/MRA was performed four to eight weeks later. DSA was performed when the CT angiography or MRI/MRA results were inconclusive or negative. The main outcome was a macrovascular cause, including arteriovenous malformation, aneurysm, dural arteriovenous fistula, and cavernoma. Three blinded neuroradiologists independently evaluated the images for macrovascular causes of haemorrhage. The reference standard was the best available evidence from all findings during one year's follow-up. STUDY ANSWER AND LIMITATIONS: A macrovascular cause was identified in 69 patients (23%). 291 patients (98%) underwent CT angiography; 214 with a negative result underwent additional MRI/MRA and 97 with a negative result for both CT angiography and MRI/MRA underwent DSA. Early CT angiography detected 51 macrovascular causes (yield 17%, 95% confidence interval 13% to 22%). CT angiography with MRI/MRA identified two additional macrovascular causes (18%, 14% to 23%) and these modalities combined with DSA another 15 (23%, 18% to 28%). This last extensive strategy failed to detect a cavernoma, which was identified on MRI during follow-up (reference strategy). The positive predictive value of CT angiography was 72% (60% to 82%), of additional MRI/MRA was 35% (14% to 62%), and of additional DSA was 100% (75% to 100%). None of the patients experienced complications with CT angiography or MRI/MRA; 0.6% of patients who underwent DSA experienced permanent sequelae. Not all patients with negative CT angiography and MR

Published
2015

4. The Preventive Antibiotics in Stroke Study (PASS): a pragmatic randomised open-label masked endpoint clinical trial

Author

Westendorp, W.F., Vermeij, J.D., Zock, E., Hooijenga, I.J., Kruyt, N.D., Bosboom, H.J., Kwa, V.I.H., Weisfelt, M., Remmers, M.J., Houten, R. ten, Schreuder, A.H., Vermeer, S.E., Dijk, E.J. van, Dippel, D.W., Dijkgraaf, M.G., Spanjaard, L., Vermeulen, M, Poll, T. van der, Prins, J.M., Vermeij, F.H., Roos, Y.B., Kleyweg, R.P., Kerkhoff, H., Brouwer, M.C.T., Zwinderman, A.H., Beek, D. van de, Nederkoorn, P.J., Westendorp, W.F., Vermeij, J.D., Zock, E., Hooijenga, I.J., Kruyt, N.D., Bosboom, H.J., Kwa, V.I.H., Weisfelt, M., Remmers, M.J., Houten, R. ten, Schreuder, A.H., Vermeer, S.E., Dijk, E.J. van, Dippel, D.W., Dijkgraaf, M.G., Spanjaard, L., Vermeulen, M, Poll, T. van der, Prins, J.M., Vermeij, F.H., Roos, Y.B., Kleyweg, R.P., Kerkhoff, H., Brouwer, M.C.T., Zwinderman, A.H., Beek, D. van de, and Nederkoorn, P.J.

Abstract

Item does not contain fulltext, BACKGROUND: In adults with acute stroke, infections occur commonly and are associated with an unfavourable functional outcome. In the Preventive Antibiotics in Stroke Study (PASS) we aimed to establish whether or not preventive antimicrobial therapy with a third-generation cephalosporin, ceftriaxone, improves functional outcome in patients with acute stroke. METHODS: In this multicentre, randomised, open-label trial with masked endpoint assessment, patients with acute stroke were randomly assigned to intravenous ceftriaxone at a dose of 2 g, given every 24 h intravenously for 4 days, in addition to stroke unit care, or standard stroke unit care without preventive antimicrobial therapy; assignments were made within 24 h after symptom onset. The primary endpoint was functional outcome at 3 months, defined according to the modified Rankin Scale and analysed by intention to treat. The primary analysis was by ordinal regression of the primary outcome. Secondary outcomes included death, infection rates, antimicrobial use, and length of hospital stay. Participants and caregivers were aware of treatment allocation but assessors of outcome were masked to group assignment. This trial is registered with controlled-trials.com, number ISRCTN66140176. FINDINGS: Between July 6, 2010, and March 23, 2014, a total of 2550 patients from 30 sites in the Netherlands, including academic and non-academic medical centres, were randomly assigned to the two treatment groups: 1275 patients to ceftriaxone and 1275 patients to standard treatment (control group). 12 patients (seven in the ceftriaxone group and five in the control group) withdrew consent immediately after randomisation, leaving 2538 patients available for the intention-to-treat-analysis (1268 in the ceftriaxone group and 1270 in the control group). 2514 (99%) of 2538 patients (1257 in each group) completed 3-month follow-up. Preventive ceftriaxone did not affect the distribution of functional outcome scores on the modified Rankin

Published
2015

5. Diagnostic yield and accuracy of CT angiography, MR angiography, and digital subtraction angiography for detection of macrovascular causes of intracerebral haemorrhage: prospective, multicentre cohort study

Author

Asch, C.J. van, Velthuis, B.K., Rinkel, G.J., Algra, A., Kort, G.A. de, Witkamp, T.D., Ridder, J.C. de, Nieuwenhuizen, K.M., Leeuw, F.E. de, Schonewille, W.J., Kort, P.L. de, Dippel, D.W., Raaymakers, T.W., Hofmeijer, J., Wermer, M.J., Kerkhoff, H., Jellema, K., Bronner, I.M., Remmers, M.J., Bienfait, H.P., Witjes, R.J., Greving, J.P., Klijn, C.J.M., Asch, C.J. van, Velthuis, B.K., Rinkel, G.J., Algra, A., Kort, G.A. de, Witkamp, T.D., Ridder, J.C. de, Nieuwenhuizen, K.M., Leeuw, F.E. de, Schonewille, W.J., Kort, P.L. de, Dippel, D.W., Raaymakers, T.W., Hofmeijer, J., Wermer, M.J., Kerkhoff, H., Jellema, K., Bronner, I.M., Remmers, M.J., Bienfait, H.P., Witjes, R.J., Greving, J.P., and Klijn, C.J.M.

Abstract

Contains fulltext : 152122.pdf (Publisher’s version ) (Open Access), STUDY QUESTION: What are the diagnostic yield and accuracy of early computed tomography (CT) angiography followed by magnetic resonance imaging/angiography (MRI/MRA) and digital subtraction angiography (DSA) in patients with non-traumatic intracerebral haemorrhage? METHODS: This prospective diagnostic study enrolled 298 adults (18-70 years) treated in 22 hospitals in the Netherlands over six years. CT angiography was performed within seven days of haemorrhage. If the result was negative, MRI/MRA was performed four to eight weeks later. DSA was performed when the CT angiography or MRI/MRA results were inconclusive or negative. The main outcome was a macrovascular cause, including arteriovenous malformation, aneurysm, dural arteriovenous fistula, and cavernoma. Three blinded neuroradiologists independently evaluated the images for macrovascular causes of haemorrhage. The reference standard was the best available evidence from all findings during one year's follow-up. STUDY ANSWER AND LIMITATIONS: A macrovascular cause was identified in 69 patients (23%). 291 patients (98%) underwent CT angiography; 214 with a negative result underwent additional MRI/MRA and 97 with a negative result for both CT angiography and MRI/MRA underwent DSA. Early CT angiography detected 51 macrovascular causes (yield 17%, 95% confidence interval 13% to 22%). CT angiography with MRI/MRA identified two additional macrovascular causes (18%, 14% to 23%) and these modalities combined with DSA another 15 (23%, 18% to 28%). This last extensive strategy failed to detect a cavernoma, which was identified on MRI during follow-up (reference strategy). The positive predictive value of CT angiography was 72% (60% to 82%), of additional MRI/MRA was 35% (14% to 62%), and of additional DSA was 100% (75% to 100%). None of the patients experienced complications with CT angiography or MRI/MRA; 0.6% of patients who underwent DSA experienced permanent sequelae. Not all patients with negative CT angiography and MR

Published
2015

6. Diagnostic yield and accuracy of CT angiography, MR angiography, and digital subtraction angiography for detection of macrovascular causes of intracerebral haemorrhage: prospective, multicentre cohort study

Author

Asch, C.J. van, Velthuis, B.K., Rinkel, G.J., Algra, A., Kort, G.A. de, Witkamp, T.D., Ridder, J.C. de, Nieuwenhuizen, K.M., Leeuw, F.E. de, Schonewille, W.J., Kort, P.L. de, Dippel, D.W., Raaymakers, T.W., Hofmeijer, J., Wermer, M.J., Kerkhoff, H., Jellema, K., Bronner, I.M., Remmers, M.J., Bienfait, H.P., Witjes, R.J., Greving, J.P., Klijn, C.J.M., Asch, C.J. van, Velthuis, B.K., Rinkel, G.J., Algra, A., Kort, G.A. de, Witkamp, T.D., Ridder, J.C. de, Nieuwenhuizen, K.M., Leeuw, F.E. de, Schonewille, W.J., Kort, P.L. de, Dippel, D.W., Raaymakers, T.W., Hofmeijer, J., Wermer, M.J., Kerkhoff, H., Jellema, K., Bronner, I.M., Remmers, M.J., Bienfait, H.P., Witjes, R.J., Greving, J.P., and Klijn, C.J.M.

Abstract

Contains fulltext : 152122.pdf (Publisher’s version ) (Open Access), STUDY QUESTION: What are the diagnostic yield and accuracy of early computed tomography (CT) angiography followed by magnetic resonance imaging/angiography (MRI/MRA) and digital subtraction angiography (DSA) in patients with non-traumatic intracerebral haemorrhage? METHODS: This prospective diagnostic study enrolled 298 adults (18-70 years) treated in 22 hospitals in the Netherlands over six years. CT angiography was performed within seven days of haemorrhage. If the result was negative, MRI/MRA was performed four to eight weeks later. DSA was performed when the CT angiography or MRI/MRA results were inconclusive or negative. The main outcome was a macrovascular cause, including arteriovenous malformation, aneurysm, dural arteriovenous fistula, and cavernoma. Three blinded neuroradiologists independently evaluated the images for macrovascular causes of haemorrhage. The reference standard was the best available evidence from all findings during one year's follow-up. STUDY ANSWER AND LIMITATIONS: A macrovascular cause was identified in 69 patients (23%). 291 patients (98%) underwent CT angiography; 214 with a negative result underwent additional MRI/MRA and 97 with a negative result for both CT angiography and MRI/MRA underwent DSA. Early CT angiography detected 51 macrovascular causes (yield 17%, 95% confidence interval 13% to 22%). CT angiography with MRI/MRA identified two additional macrovascular causes (18%, 14% to 23%) and these modalities combined with DSA another 15 (23%, 18% to 28%). This last extensive strategy failed to detect a cavernoma, which was identified on MRI during follow-up (reference strategy). The positive predictive value of CT angiography was 72% (60% to 82%), of additional MRI/MRA was 35% (14% to 62%), and of additional DSA was 100% (75% to 100%). None of the patients experienced complications with CT angiography or MRI/MRA; 0.6% of patients who underwent DSA experienced permanent sequelae. Not all patients with negative CT angiography and MR

Published
2015

7. The Preventive Antibiotics in Stroke Study (PASS): a pragmatic randomised open-label masked endpoint clinical trial

Author

Westendorp, W.F., Vermeij, J.D., Zock, E., Hooijenga, I.J., Kruyt, N.D., Bosboom, H.J., Kwa, V.I.H., Weisfelt, M., Remmers, M.J., Houten, R. ten, Schreuder, A.H., Vermeer, S.E., Dijk, E.J. van, Dippel, D.W., Dijkgraaf, M.G., Spanjaard, L., Vermeulen, M, Poll, T. van der, Prins, J.M., Vermeij, F.H., Roos, Y.B., Kleyweg, R.P., Kerkhoff, H., Brouwer, M.C.T., Zwinderman, A.H., Beek, D. van de, Nederkoorn, P.J., Westendorp, W.F., Vermeij, J.D., Zock, E., Hooijenga, I.J., Kruyt, N.D., Bosboom, H.J., Kwa, V.I.H., Weisfelt, M., Remmers, M.J., Houten, R. ten, Schreuder, A.H., Vermeer, S.E., Dijk, E.J. van, Dippel, D.W., Dijkgraaf, M.G., Spanjaard, L., Vermeulen, M, Poll, T. van der, Prins, J.M., Vermeij, F.H., Roos, Y.B., Kleyweg, R.P., Kerkhoff, H., Brouwer, M.C.T., Zwinderman, A.H., Beek, D. van de, and Nederkoorn, P.J.

Abstract

Item does not contain fulltext, BACKGROUND: In adults with acute stroke, infections occur commonly and are associated with an unfavourable functional outcome. In the Preventive Antibiotics in Stroke Study (PASS) we aimed to establish whether or not preventive antimicrobial therapy with a third-generation cephalosporin, ceftriaxone, improves functional outcome in patients with acute stroke. METHODS: In this multicentre, randomised, open-label trial with masked endpoint assessment, patients with acute stroke were randomly assigned to intravenous ceftriaxone at a dose of 2 g, given every 24 h intravenously for 4 days, in addition to stroke unit care, or standard stroke unit care without preventive antimicrobial therapy; assignments were made within 24 h after symptom onset. The primary endpoint was functional outcome at 3 months, defined according to the modified Rankin Scale and analysed by intention to treat. The primary analysis was by ordinal regression of the primary outcome. Secondary outcomes included death, infection rates, antimicrobial use, and length of hospital stay. Participants and caregivers were aware of treatment allocation but assessors of outcome were masked to group assignment. This trial is registered with controlled-trials.com, number ISRCTN66140176. FINDINGS: Between July 6, 2010, and March 23, 2014, a total of 2550 patients from 30 sites in the Netherlands, including academic and non-academic medical centres, were randomly assigned to the two treatment groups: 1275 patients to ceftriaxone and 1275 patients to standard treatment (control group). 12 patients (seven in the ceftriaxone group and five in the control group) withdrew consent immediately after randomisation, leaving 2538 patients available for the intention-to-treat-analysis (1268 in the ceftriaxone group and 1270 in the control group). 2514 (99%) of 2538 patients (1257 in each group) completed 3-month follow-up. Preventive ceftriaxone did not affect the distribution of functional outcome scores on the modified Rankin

Published
2015

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