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Prophylactic platelet transfusion plus supportive care versus supportive care alone in adults with dengue and thrombocytopenia: a multicentre, open-label, randomised, superiority trial

Summary Background Dengue is the commonest vector-borne infection worldwide. It is often associated with thrombocytopenia, and prophylactic platelet transfusion is widely used despite the dearth of robust evidence. We aimed to assess the efficacy and safety of prophylactic platelet transfusion in th... Full description

Journal Title: The Lancet (British edition) 2017, Vol.389 (10079), p.1611-1618
Main Author: Lye, David C, Dr
Other Authors: Archuleta, Sophia, MD , Syed-Omar, Sharifah F, MMed , Low, Jenny G, MRCP , Oh, Helen M, FRCP , Wei, Yuan, MS , Fisher, Dale, Prof , Ponnampalavanar, Sasheela S L, MMed , Wijaya, Limin, MRCP , Lee, Linda K, MPH , Ooi, Eng-Eong, Prof , Kamarulzaman, Adeeba, Prof , Lum, Lucy C, Prof , Tambyah, Paul A, Prof , Leo, Yee-Sin, Prof
Format: Electronic Article Electronic Article
Language: English
Subjects:
Quelle: Alma/SFX Local Collection
Publisher: England: Elsevier Ltd
ID: ISSN: 0140-6736
Link: https://www.ncbi.nlm.nih.gov/pubmed/28283286
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title: Prophylactic platelet transfusion plus supportive care versus supportive care alone in adults with dengue and thrombocytopenia: a multicentre, open-label, randomised, superiority trial
format: Article
creator:
  • Lye, David C, Dr
  • Archuleta, Sophia, MD
  • Syed-Omar, Sharifah F, MMed
  • Low, Jenny G, MRCP
  • Oh, Helen M, FRCP
  • Wei, Yuan, MS
  • Fisher, Dale, Prof
  • Ponnampalavanar, Sasheela S L, MMed
  • Wijaya, Limin, MRCP
  • Lee, Linda K, MPH
  • Ooi, Eng-Eong, Prof
  • Kamarulzaman, Adeeba, Prof
  • Lum, Lucy C, Prof
  • Tambyah, Paul A, Prof
  • Leo, Yee-Sin, Prof
subjects:
  • Abridged Index Medicus
  • Adult
  • Adults
  • Analysis
  • Blood platelets
  • Clinical trials
  • Communicable diseases
  • Dengue
  • Dengue - complications
  • Epidemiology
  • Equivalence Trials as Topic
  • Female
  • Health aspects
  • Hemorrhage - etiology
  • Hemorrhage - prevention & control
  • Humans
  • Internal Medicine
  • Malaysia
  • Male
  • Medical colleges
  • Middle Aged
  • Platelet Transfusion
  • Singapore
  • Thrombocytopenia
  • Thrombocytopenia - complications
  • Transfusion
  • Treatment Outcome
ispartof: The Lancet (British edition), 2017, Vol.389 (10079), p.1611-1618
description: Summary Background Dengue is the commonest vector-borne infection worldwide. It is often associated with thrombocytopenia, and prophylactic platelet transfusion is widely used despite the dearth of robust evidence. We aimed to assess the efficacy and safety of prophylactic platelet transfusion in the prevention of bleeding in adults with dengue and thrombocytopenia. Methods We did an open-label, randomised, superiority trial in five hospitals in Singapore and Malaysia. We recruited patients aged at least 21 years who had laboratory-confirmed dengue (confirmed or probable) and thrombocytopenia (≤20 000 platelets per μL), without persistent mild bleeding or any severe bleeding. Patients were assigned (1:1), with randomly permuted block sizes of four or six and stratified by centre, to receive prophylactic platelet transfusion in addition to supportive care (transfusion group) or supportive care alone (control group). In the transfusion group, 4 units of pooled platelets were given each day when platelet count was 20 000 per μL or lower; supportive care consisted of bed rest, fluid therapy, and fever and pain medications. The primary endpoint was clinical bleeding (excluding petechiae) by study day 7 or hospital discharge (whichever was earlier), analysed by intention to treat. Safety outcomes were analysed according to the actual treatment received. This study was registered with ClinicalTrials.gov , number NCT01030211 , and is completed. Findings Between April 29, 2010, and Dec 9, 2014, we randomly assigned 372 patients to the transfusion group (n=188) or the control group (n=184). The intention-to-treat analysis included 187 patients in the transfusion group (one patient was withdrawn immediately) and 182 in the control group (one was withdrawn immediately and one did not have confirmed or probable dengue). Clinical bleeding by day 7 or hospital discharge occurred in 40 (21%) patients in the transfusion group and 48 (26%) patients in the control group (risk difference −4·98% [95% CI −15·08 to 5·34]; relative risk 0·81 [95% CI 0·56 to 1·17]; p=0·16). 13 adverse events occurred in the transfusion group and two occurred in the control group (5·81% [–4·42 to 16·01]; 6·26 [1·43 to 27·34]; p=0·0064). Adverse events that were possibly, probably, or definitely related to transfusion included three cases of urticaria, one maculopapular rash, one pruritus, and one chest pain, as well as one case each of anaphylaxis, transfusion-related acute lung injury, and fluid o
language: eng
source: Alma/SFX Local Collection
identifier: ISSN: 0140-6736
fulltext: fulltext
issn:
  • 0140-6736
  • 1474-547X
url: Link


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titleProphylactic platelet transfusion plus supportive care versus supportive care alone in adults with dengue and thrombocytopenia: a multicentre, open-label, randomised, superiority trial
sourceAlma/SFX Local Collection
creatorLye, David C, Dr ; Archuleta, Sophia, MD ; Syed-Omar, Sharifah F, MMed ; Low, Jenny G, MRCP ; Oh, Helen M, FRCP ; Wei, Yuan, MS ; Fisher, Dale, Prof ; Ponnampalavanar, Sasheela S L, MMed ; Wijaya, Limin, MRCP ; Lee, Linda K, MPH ; Ooi, Eng-Eong, Prof ; Kamarulzaman, Adeeba, Prof ; Lum, Lucy C, Prof ; Tambyah, Paul A, Prof ; Leo, Yee-Sin, Prof
creatorcontribLye, David C, Dr ; Archuleta, Sophia, MD ; Syed-Omar, Sharifah F, MMed ; Low, Jenny G, MRCP ; Oh, Helen M, FRCP ; Wei, Yuan, MS ; Fisher, Dale, Prof ; Ponnampalavanar, Sasheela S L, MMed ; Wijaya, Limin, MRCP ; Lee, Linda K, MPH ; Ooi, Eng-Eong, Prof ; Kamarulzaman, Adeeba, Prof ; Lum, Lucy C, Prof ; Tambyah, Paul A, Prof ; Leo, Yee-Sin, Prof
descriptionSummary Background Dengue is the commonest vector-borne infection worldwide. It is often associated with thrombocytopenia, and prophylactic platelet transfusion is widely used despite the dearth of robust evidence. We aimed to assess the efficacy and safety of prophylactic platelet transfusion in the prevention of bleeding in adults with dengue and thrombocytopenia. Methods We did an open-label, randomised, superiority trial in five hospitals in Singapore and Malaysia. We recruited patients aged at least 21 years who had laboratory-confirmed dengue (confirmed or probable) and thrombocytopenia (≤20 000 platelets per μL), without persistent mild bleeding or any severe bleeding. Patients were assigned (1:1), with randomly permuted block sizes of four or six and stratified by centre, to receive prophylactic platelet transfusion in addition to supportive care (transfusion group) or supportive care alone (control group). In the transfusion group, 4 units of pooled platelets were given each day when platelet count was 20 000 per μL or lower; supportive care consisted of bed rest, fluid therapy, and fever and pain medications. The primary endpoint was clinical bleeding (excluding petechiae) by study day 7 or hospital discharge (whichever was earlier), analysed by intention to treat. Safety outcomes were analysed according to the actual treatment received. This study was registered with ClinicalTrials.gov , number NCT01030211 , and is completed. Findings Between April 29, 2010, and Dec 9, 2014, we randomly assigned 372 patients to the transfusion group (n=188) or the control group (n=184). The intention-to-treat analysis included 187 patients in the transfusion group (one patient was withdrawn immediately) and 182 in the control group (one was withdrawn immediately and one did not have confirmed or probable dengue). Clinical bleeding by day 7 or hospital discharge occurred in 40 (21%) patients in the transfusion group and 48 (26%) patients in the control group (risk difference −4·98% [95% CI −15·08 to 5·34]; relative risk 0·81 [95% CI 0·56 to 1·17]; p=0·16). 13 adverse events occurred in the transfusion group and two occurred in the control group (5·81% [–4·42 to 16·01]; 6·26 [1·43 to 27·34]; p=0·0064). Adverse events that were possibly, probably, or definitely related to transfusion included three cases of urticaria, one maculopapular rash, one pruritus, and one chest pain, as well as one case each of anaphylaxis, transfusion-related acute lung injury, and fluid overload that resulted in serious adverse events. No death was reported. Interpretation In adult patients with dengue and thrombocytopenia, prophylactic platelet transfusion was not superior to supportive care in preventing bleeding, and might be associated with adverse events. Funding National Medical Research Council, Singapore.
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languageeng
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subjectAbridged Index Medicus ; Adult ; Adults ; Analysis ; Blood platelets ; Clinical trials ; Communicable diseases ; Dengue ; Dengue - complications ; Epidemiology ; Equivalence Trials as Topic ; Female ; Health aspects ; Hemorrhage - etiology ; Hemorrhage - prevention & control ; Humans ; Internal Medicine ; Malaysia ; Male ; Medical colleges ; Middle Aged ; Platelet Transfusion ; Singapore ; Thrombocytopenia ; Thrombocytopenia - complications ; Transfusion ; Treatment Outcome
ispartofThe Lancet (British edition), 2017, Vol.389 (10079), p.1611-1618
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0Lye, David C, Dr
1Archuleta, Sophia, MD
2Syed-Omar, Sharifah F, MMed
3Low, Jenny G, MRCP
4Oh, Helen M, FRCP
5Wei, Yuan, MS
6Fisher, Dale, Prof
7Ponnampalavanar, Sasheela S L, MMed
8Wijaya, Limin, MRCP
9Lee, Linda K, MPH
10Ooi, Eng-Eong, Prof
11Kamarulzaman, Adeeba, Prof
12Lum, Lucy C, Prof
13Tambyah, Paul A, Prof
14Leo, Yee-Sin, Prof
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0Prophylactic platelet transfusion plus supportive care versus supportive care alone in adults with dengue and thrombocytopenia: a multicentre, open-label, randomised, superiority trial
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descriptionSummary Background Dengue is the commonest vector-borne infection worldwide. It is often associated with thrombocytopenia, and prophylactic platelet transfusion is widely used despite the dearth of robust evidence. We aimed to assess the efficacy and safety of prophylactic platelet transfusion in the prevention of bleeding in adults with dengue and thrombocytopenia. Methods We did an open-label, randomised, superiority trial in five hospitals in Singapore and Malaysia. We recruited patients aged at least 21 years who had laboratory-confirmed dengue (confirmed or probable) and thrombocytopenia (≤20 000 platelets per μL), without persistent mild bleeding or any severe bleeding. Patients were assigned (1:1), with randomly permuted block sizes of four or six and stratified by centre, to receive prophylactic platelet transfusion in addition to supportive care (transfusion group) or supportive care alone (control group). In the transfusion group, 4 units of pooled platelets were given each day when platelet count was 20 000 per μL or lower; supportive care consisted of bed rest, fluid therapy, and fever and pain medications. The primary endpoint was clinical bleeding (excluding petechiae) by study day 7 or hospital discharge (whichever was earlier), analysed by intention to treat. Safety outcomes were analysed according to the actual treatment received. This study was registered with ClinicalTrials.gov , number NCT01030211 , and is completed. Findings Between April 29, 2010, and Dec 9, 2014, we randomly assigned 372 patients to the transfusion group (n=188) or the control group (n=184). The intention-to-treat analysis included 187 patients in the transfusion group (one patient was withdrawn immediately) and 182 in the control group (one was withdrawn immediately and one did not have confirmed or probable dengue). Clinical bleeding by day 7 or hospital discharge occurred in 40 (21%) patients in the transfusion group and 48 (26%) patients in the control group (risk difference −4·98% [95% CI −15·08 to 5·34]; relative risk 0·81 [95% CI 0·56 to 1·17]; p=0·16). 13 adverse events occurred in the transfusion group and two occurred in the control group (5·81% [–4·42 to 16·01]; 6·26 [1·43 to 27·34]; p=0·0064). Adverse events that were possibly, probably, or definitely related to transfusion included three cases of urticaria, one maculopapular rash, one pruritus, and one chest pain, as well as one case each of anaphylaxis, transfusion-related acute lung injury, and fluid overload that resulted in serious adverse events. No death was reported. Interpretation In adult patients with dengue and thrombocytopenia, prophylactic platelet transfusion was not superior to supportive care in preventing bleeding, and might be associated with adverse events. Funding National Medical Research Council, Singapore.
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9Epidemiology
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15Humans
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19Medical colleges
20Middle Aged
21Platelet Transfusion
22Singapore
23Thrombocytopenia
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26Treatment Outcome
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10Ooi, Eng-Eong, Prof
11Kamarulzaman, Adeeba, Prof
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13Tambyah, Paul A, Prof
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titleProphylactic platelet transfusion plus supportive care versus supportive care alone in adults with dengue and thrombocytopenia: a multicentre, open-label, randomised, superiority trial
authorLye, David C, Dr ; Archuleta, Sophia, MD ; Syed-Omar, Sharifah F, MMed ; Low, Jenny G, MRCP ; Oh, Helen M, FRCP ; Wei, Yuan, MS ; Fisher, Dale, Prof ; Ponnampalavanar, Sasheela S L, MMed ; Wijaya, Limin, MRCP ; Lee, Linda K, MPH ; Ooi, Eng-Eong, Prof ; Kamarulzaman, Adeeba, Prof ; Lum, Lucy C, Prof ; Tambyah, Paul A, Prof ; Leo, Yee-Sin, Prof
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10Equivalence Trials as Topic
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14Hemorrhage - prevention & control
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abstractSummary Background Dengue is the commonest vector-borne infection worldwide. It is often associated with thrombocytopenia, and prophylactic platelet transfusion is widely used despite the dearth of robust evidence. We aimed to assess the efficacy and safety of prophylactic platelet transfusion in the prevention of bleeding in adults with dengue and thrombocytopenia. Methods We did an open-label, randomised, superiority trial in five hospitals in Singapore and Malaysia. We recruited patients aged at least 21 years who had laboratory-confirmed dengue (confirmed or probable) and thrombocytopenia (≤20 000 platelets per μL), without persistent mild bleeding or any severe bleeding. Patients were assigned (1:1), with randomly permuted block sizes of four or six and stratified by centre, to receive prophylactic platelet transfusion in addition to supportive care (transfusion group) or supportive care alone (control group). In the transfusion group, 4 units of pooled platelets were given each day when platelet count was 20 000 per μL or lower; supportive care consisted of bed rest, fluid therapy, and fever and pain medications. The primary endpoint was clinical bleeding (excluding petechiae) by study day 7 or hospital discharge (whichever was earlier), analysed by intention to treat. Safety outcomes were analysed according to the actual treatment received. This study was registered with ClinicalTrials.gov , number NCT01030211 , and is completed. Findings Between April 29, 2010, and Dec 9, 2014, we randomly assigned 372 patients to the transfusion group (n=188) or the control group (n=184). The intention-to-treat analysis included 187 patients in the transfusion group (one patient was withdrawn immediately) and 182 in the control group (one was withdrawn immediately and one did not have confirmed or probable dengue). Clinical bleeding by day 7 or hospital discharge occurred in 40 (21%) patients in the transfusion group and 48 (26%) patients in the control group (risk difference −4·98% [95% CI −15·08 to 5·34]; relative risk 0·81 [95% CI 0·56 to 1·17]; p=0·16). 13 adverse events occurred in the transfusion group and two occurred in the control group (5·81% [–4·42 to 16·01]; 6·26 [1·43 to 27·34]; p=0·0064). Adverse events that were possibly, probably, or definitely related to transfusion included three cases of urticaria, one maculopapular rash, one pruritus, and one chest pain, as well as one case each of anaphylaxis, transfusion-related acute lung injury, and fluid overload that resulted in serious adverse events. No death was reported. Interpretation In adult patients with dengue and thrombocytopenia, prophylactic platelet transfusion was not superior to supportive care in preventing bleeding, and might be associated with adverse events. Funding National Medical Research Council, Singapore.
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pmid28283286
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