A randomized controlled trial of fresh frozen plasma for coagulopathy in Russell's viper (Daboia russelii) envenoming
Essentials Russell's viper envenoming is a major health issue in South Asia and causes coagulopathy. We studied the effect of fresh frozen plasma and two antivenom doses on correcting coagulopathy. Fresh frozen plasma did not hasten recovery of coagulopathy. Low‐dose antivenom did not worsen co...
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| Veröffentlicht in: | Journal of thrombosis and haemostasis 2017-04, Vol.15 (4), p.645-654 |
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| creator | Isbister, G. K. Jayamanne, S. Mohamed, F. Dawson, A. H. Maduwage, K. Gawarammana, I. Lalloo, D. G. Silva, H. J. Scorgie, F. E. Lincz, L. F. Buckley, N. A. |
| description | Essentials
Russell's viper envenoming is a major health issue in South Asia and causes coagulopathy.
We studied the effect of fresh frozen plasma and two antivenom doses on correcting coagulopathy.
Fresh frozen plasma did not hasten recovery of coagulopathy.
Low‐dose antivenom did not worsen coagulopathy.
Summary
Background
Russell's viper (Daboia russelii) envenoming is a major health issue in South Asia and causes venom‐induced consumption coagulopathy (VICC).
Objectives
To investigate the effects of fresh frozen plasma (FFP) and two antivenom doses in correcting VICC.
Methods
We undertook an open‐label randomized controlled trial in patients with VICC at two Sri Lankan hospitals. Patients with suspected Russell's viper bites and coagulopathy were randomly allocated (1 : 1) to high‐dose antivenom (20 vials) or low‐dose antivenom (10 vials) plus 4 U of FFP. The primary outcome was the proportion of patients with an International Normalized Ratio (INR) of < 2 at 6 h after antivenom administration. Secondary outcomes included anaphylaxis, major hemorrhage, death, and clotting factor recovery.
Results
From 214 eligible patients, 141 were randomized: 71 to high‐dose antivenom, and 70 to low‐dose antivenom/FFP; five had no post‐antivenom blood tests. The groups were similar except for a delay of 1 h in antivenom administration for FFP patients. Six hours after antivenom administration, 23 of 69 (33%) patients allocated to high‐dose antivenom had an INR of < 2, as compared with 28 of 67 (42%) allocated to low‐dose antivenom/FFP (absolute difference 8%; 95% confidence interval − 8% to 25%). Fifteen patients allocated to FFP did not receive it. Severe anaphylaxis occurred equally frequently in each group. One patient given FFP developed transfusion‐related acute lung injury. Three deaths occurred in low‐dose antivenom/FFP patients, including one intracranial hemorrhage. There was no difference in recovery rates of INR or fibrinogen, but there was more rapid initial recovery of factor V and FX in FFP patients.
Conclusion
FFP after antivenom administration in patients with Russell's viper bites did not hasten recovery of coagulopathy. Low‐dose antivenom/FFP did not worsen VICC, suggesting that low‐dose antivenom is sufficient. |
| doi_str_mv | 10.1111/jth.13628 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_5408386</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>4321377735</sourcerecordid><originalsourceid>FETCH-LOGICAL-c4438-deeb6ed97d345f62c2d434cf1c122772add82e5610b43c4ad34643824780345c3</originalsourceid><addsrcrecordid>eNp1kUtPGzEUhS1EVR7tgj9QWWJBWQT8Go-zQUL0QSukShVdW459J3Hk2IM9ExR-PS4BVBb1wr6yv3vusQ5CR5Sc0brOl8PijHLJ1A7apw1Xk1ZxuftSTznfQwelLAmh04aR92iPKUok53QfjZc4m-jSyj-AwzbFIacQajlkbwJOHe4ylEXd0wNE3AdTVgZ3KVfWzMeQejMsNthH_HssBUI4KXjte8j48xczS97g_HTv_SmGuIZYJ8X5B_SuM6HAx-fzEP359vX26npy8-v7j6vLm4kVolp3ADMJbto6LppOMsuc4MJ21FLG2pYZ5xSDRlIyE9wKUzFZ-5hoFakdlh-ii61uP85W4CzU75mg--xXJm90Ml6_fYl-oedprRtBFFeyChw_C-R0N0IZ9DKNOVbPmirFKZm2klbqdEvZnErJ0L1OoET_TUjXhPRTQpX99K-lV_Ilkgqcb4F7H2DzfyX98_Z6K_kIlhWctg</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1883109761</pqid></control><display><type>article</type><title>A randomized controlled trial of fresh frozen plasma for coagulopathy in Russell's viper (Daboia russelii) envenoming</title><source>MEDLINE</source><source>Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals</source><source>Alma/SFX Local Collection</source><creator>Isbister, G. K. ; Jayamanne, S. ; Mohamed, F. ; Dawson, A. H. ; Maduwage, K. ; Gawarammana, I. ; Lalloo, D. G. ; Silva, H. J. ; Scorgie, F. E. ; Lincz, L. F. ; Buckley, N. A.</creator><creatorcontrib>Isbister, G. K. ; Jayamanne, S. ; Mohamed, F. ; Dawson, A. H. ; Maduwage, K. ; Gawarammana, I. ; Lalloo, D. G. ; Silva, H. J. ; Scorgie, F. E. ; Lincz, L. F. ; Buckley, N. A.</creatorcontrib><description>Essentials
Russell's viper envenoming is a major health issue in South Asia and causes coagulopathy.
We studied the effect of fresh frozen plasma and two antivenom doses on correcting coagulopathy.
Fresh frozen plasma did not hasten recovery of coagulopathy.
Low‐dose antivenom did not worsen coagulopathy.
Summary
Background
Russell's viper (Daboia russelii) envenoming is a major health issue in South Asia and causes venom‐induced consumption coagulopathy (VICC).
Objectives
To investigate the effects of fresh frozen plasma (FFP) and two antivenom doses in correcting VICC.
Methods
We undertook an open‐label randomized controlled trial in patients with VICC at two Sri Lankan hospitals. Patients with suspected Russell's viper bites and coagulopathy were randomly allocated (1 : 1) to high‐dose antivenom (20 vials) or low‐dose antivenom (10 vials) plus 4 U of FFP. The primary outcome was the proportion of patients with an International Normalized Ratio (INR) of < 2 at 6 h after antivenom administration. Secondary outcomes included anaphylaxis, major hemorrhage, death, and clotting factor recovery.
Results
From 214 eligible patients, 141 were randomized: 71 to high‐dose antivenom, and 70 to low‐dose antivenom/FFP; five had no post‐antivenom blood tests. The groups were similar except for a delay of 1 h in antivenom administration for FFP patients. Six hours after antivenom administration, 23 of 69 (33%) patients allocated to high‐dose antivenom had an INR of < 2, as compared with 28 of 67 (42%) allocated to low‐dose antivenom/FFP (absolute difference 8%; 95% confidence interval − 8% to 25%). Fifteen patients allocated to FFP did not receive it. Severe anaphylaxis occurred equally frequently in each group. One patient given FFP developed transfusion‐related acute lung injury. Three deaths occurred in low‐dose antivenom/FFP patients, including one intracranial hemorrhage. There was no difference in recovery rates of INR or fibrinogen, but there was more rapid initial recovery of factor V and FX in FFP patients.
Conclusion
FFP after antivenom administration in patients with Russell's viper bites did not hasten recovery of coagulopathy. Low‐dose antivenom/FFP did not worsen VICC, suggesting that low‐dose antivenom is sufficient.</description><identifier>ISSN: 1538-7933</identifier><identifier>ISSN: 1538-7836</identifier><identifier>EISSN: 1538-7836</identifier><identifier>DOI: 10.1111/jth.13628</identifier><identifier>PMID: 28106331</identifier><language>eng</language><publisher>England: Elsevier Limited</publisher><subject>Adolescent ; Adult ; Anaphylaxis ; Animals ; Antivenins - therapeutic use ; antivenoms ; Blood Coagulation ; Blood Coagulation Factors - administration & dosage ; CLINICAL HAEMOSTASIS AND THROMBOSIS ; Clinical trials ; consumption coagulopathy ; Daboia ; Disseminated Intravascular Coagulation - etiology ; Disseminated Intravascular Coagulation - therapy ; Female ; Hemorrhage ; Hemorrhage - chemically induced ; Humans ; International Normalized Ratio ; Male ; Middle Aged ; Original ; Plasma ; Prospective Studies ; Snake Bites - therapy ; snake venoms ; snakebites ; Sri Lanka ; Time Factors ; Treatment Outcome ; Viper Venoms</subject><ispartof>Journal of thrombosis and haemostasis, 2017-04, Vol.15 (4), p.645-654</ispartof><rights>2017 The Authors. published by Wiley Periodicals, Inc. on behalf of International Society on Thrombosis and Haemostasis.</rights><rights>2017 The Authors. Journal of Thrombosis and Haemostasis published by Wiley Periodicals, Inc. on behalf of International Society on Thrombosis and Haemostasis.</rights><rights>Copyright © 2017 International Society on Thrombosis and Haemostasis</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4438-deeb6ed97d345f62c2d434cf1c122772add82e5610b43c4ad34643824780345c3</citedby><cites>FETCH-LOGICAL-c4438-deeb6ed97d345f62c2d434cf1c122772add82e5610b43c4ad34643824780345c3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,777,781,882,27905,27906</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/28106331$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Isbister, G. K.</creatorcontrib><creatorcontrib>Jayamanne, S.</creatorcontrib><creatorcontrib>Mohamed, F.</creatorcontrib><creatorcontrib>Dawson, A. H.</creatorcontrib><creatorcontrib>Maduwage, K.</creatorcontrib><creatorcontrib>Gawarammana, I.</creatorcontrib><creatorcontrib>Lalloo, D. G.</creatorcontrib><creatorcontrib>Silva, H. J.</creatorcontrib><creatorcontrib>Scorgie, F. E.</creatorcontrib><creatorcontrib>Lincz, L. F.</creatorcontrib><creatorcontrib>Buckley, N. A.</creatorcontrib><title>A randomized controlled trial of fresh frozen plasma for coagulopathy in Russell's viper (Daboia russelii) envenoming</title><title>Journal of thrombosis and haemostasis</title><addtitle>J Thromb Haemost</addtitle><description>Essentials
Russell's viper envenoming is a major health issue in South Asia and causes coagulopathy.
We studied the effect of fresh frozen plasma and two antivenom doses on correcting coagulopathy.
Fresh frozen plasma did not hasten recovery of coagulopathy.
Low‐dose antivenom did not worsen coagulopathy.
Summary
Background
Russell's viper (Daboia russelii) envenoming is a major health issue in South Asia and causes venom‐induced consumption coagulopathy (VICC).
Objectives
To investigate the effects of fresh frozen plasma (FFP) and two antivenom doses in correcting VICC.
Methods
We undertook an open‐label randomized controlled trial in patients with VICC at two Sri Lankan hospitals. Patients with suspected Russell's viper bites and coagulopathy were randomly allocated (1 : 1) to high‐dose antivenom (20 vials) or low‐dose antivenom (10 vials) plus 4 U of FFP. The primary outcome was the proportion of patients with an International Normalized Ratio (INR) of < 2 at 6 h after antivenom administration. Secondary outcomes included anaphylaxis, major hemorrhage, death, and clotting factor recovery.
Results
From 214 eligible patients, 141 were randomized: 71 to high‐dose antivenom, and 70 to low‐dose antivenom/FFP; five had no post‐antivenom blood tests. The groups were similar except for a delay of 1 h in antivenom administration for FFP patients. Six hours after antivenom administration, 23 of 69 (33%) patients allocated to high‐dose antivenom had an INR of < 2, as compared with 28 of 67 (42%) allocated to low‐dose antivenom/FFP (absolute difference 8%; 95% confidence interval − 8% to 25%). Fifteen patients allocated to FFP did not receive it. Severe anaphylaxis occurred equally frequently in each group. One patient given FFP developed transfusion‐related acute lung injury. Three deaths occurred in low‐dose antivenom/FFP patients, including one intracranial hemorrhage. There was no difference in recovery rates of INR or fibrinogen, but there was more rapid initial recovery of factor V and FX in FFP patients.
Conclusion
FFP after antivenom administration in patients with Russell's viper bites did not hasten recovery of coagulopathy. Low‐dose antivenom/FFP did not worsen VICC, suggesting that low‐dose antivenom is sufficient.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Anaphylaxis</subject><subject>Animals</subject><subject>Antivenins - therapeutic use</subject><subject>antivenoms</subject><subject>Blood Coagulation</subject><subject>Blood Coagulation Factors - administration & dosage</subject><subject>CLINICAL HAEMOSTASIS AND THROMBOSIS</subject><subject>Clinical trials</subject><subject>consumption coagulopathy</subject><subject>Daboia</subject><subject>Disseminated Intravascular Coagulation - etiology</subject><subject>Disseminated Intravascular Coagulation - therapy</subject><subject>Female</subject><subject>Hemorrhage</subject><subject>Hemorrhage - chemically induced</subject><subject>Humans</subject><subject>International Normalized Ratio</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Original</subject><subject>Plasma</subject><subject>Prospective Studies</subject><subject>Snake Bites - therapy</subject><subject>snake venoms</subject><subject>snakebites</subject><subject>Sri Lanka</subject><subject>Time Factors</subject><subject>Treatment Outcome</subject><subject>Viper Venoms</subject><issn>1538-7933</issn><issn>1538-7836</issn><issn>1538-7836</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><sourceid>WIN</sourceid><sourceid>EIF</sourceid><recordid>eNp1kUtPGzEUhS1EVR7tgj9QWWJBWQT8Go-zQUL0QSukShVdW459J3Hk2IM9ExR-PS4BVBb1wr6yv3vusQ5CR5Sc0brOl8PijHLJ1A7apw1Xk1ZxuftSTznfQwelLAmh04aR92iPKUok53QfjZc4m-jSyj-AwzbFIacQajlkbwJOHe4ylEXd0wNE3AdTVgZ3KVfWzMeQejMsNthH_HssBUI4KXjte8j48xczS97g_HTv_SmGuIZYJ8X5B_SuM6HAx-fzEP359vX26npy8-v7j6vLm4kVolp3ADMJbto6LppOMsuc4MJ21FLG2pYZ5xSDRlIyE9wKUzFZ-5hoFakdlh-ii61uP85W4CzU75mg--xXJm90Ml6_fYl-oedprRtBFFeyChw_C-R0N0IZ9DKNOVbPmirFKZm2klbqdEvZnErJ0L1OoET_TUjXhPRTQpX99K-lV_Ilkgqcb4F7H2DzfyX98_Z6K_kIlhWctg</recordid><startdate>201704</startdate><enddate>201704</enddate><creator>Isbister, G. K.</creator><creator>Jayamanne, S.</creator><creator>Mohamed, F.</creator><creator>Dawson, A. H.</creator><creator>Maduwage, K.</creator><creator>Gawarammana, I.</creator><creator>Lalloo, D. G.</creator><creator>Silva, H. J.</creator><creator>Scorgie, F. E.</creator><creator>Lincz, L. F.</creator><creator>Buckley, N. A.</creator><general>Elsevier Limited</general><general>John Wiley and Sons Inc</general><scope>24P</scope><scope>WIN</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7T5</scope><scope>H94</scope><scope>K9.</scope><scope>5PM</scope></search><sort><creationdate>201704</creationdate><title>A randomized controlled trial of fresh frozen plasma for coagulopathy in Russell's viper (Daboia russelii) envenoming</title><author>Isbister, G. K. ; Jayamanne, S. ; Mohamed, F. ; Dawson, A. H. ; Maduwage, K. ; Gawarammana, I. ; Lalloo, D. G. ; Silva, H. J. ; Scorgie, F. E. ; Lincz, L. F. ; Buckley, N. A.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4438-deeb6ed97d345f62c2d434cf1c122772add82e5610b43c4ad34643824780345c3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Anaphylaxis</topic><topic>Animals</topic><topic>Antivenins - therapeutic use</topic><topic>antivenoms</topic><topic>Blood Coagulation</topic><topic>Blood Coagulation Factors - administration & dosage</topic><topic>CLINICAL HAEMOSTASIS AND THROMBOSIS</topic><topic>Clinical trials</topic><topic>consumption coagulopathy</topic><topic>Daboia</topic><topic>Disseminated Intravascular Coagulation - etiology</topic><topic>Disseminated Intravascular Coagulation - therapy</topic><topic>Female</topic><topic>Hemorrhage</topic><topic>Hemorrhage - chemically induced</topic><topic>Humans</topic><topic>International Normalized Ratio</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Original</topic><topic>Plasma</topic><topic>Prospective Studies</topic><topic>Snake Bites - therapy</topic><topic>snake venoms</topic><topic>snakebites</topic><topic>Sri Lanka</topic><topic>Time Factors</topic><topic>Treatment Outcome</topic><topic>Viper Venoms</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Isbister, G. K.</creatorcontrib><creatorcontrib>Jayamanne, S.</creatorcontrib><creatorcontrib>Mohamed, F.</creatorcontrib><creatorcontrib>Dawson, A. H.</creatorcontrib><creatorcontrib>Maduwage, K.</creatorcontrib><creatorcontrib>Gawarammana, I.</creatorcontrib><creatorcontrib>Lalloo, D. G.</creatorcontrib><creatorcontrib>Silva, H. J.</creatorcontrib><creatorcontrib>Scorgie, F. E.</creatorcontrib><creatorcontrib>Lincz, L. F.</creatorcontrib><creatorcontrib>Buckley, N. A.</creatorcontrib><collection>Wiley-Blackwell Open Access Titles</collection><collection>Wiley Free Content</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Journal of thrombosis and haemostasis</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Isbister, G. K.</au><au>Jayamanne, S.</au><au>Mohamed, F.</au><au>Dawson, A. H.</au><au>Maduwage, K.</au><au>Gawarammana, I.</au><au>Lalloo, D. G.</au><au>Silva, H. J.</au><au>Scorgie, F. E.</au><au>Lincz, L. F.</au><au>Buckley, N. A.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A randomized controlled trial of fresh frozen plasma for coagulopathy in Russell's viper (Daboia russelii) envenoming</atitle><jtitle>Journal of thrombosis and haemostasis</jtitle><addtitle>J Thromb Haemost</addtitle><date>2017-04</date><risdate>2017</risdate><volume>15</volume><issue>4</issue><spage>645</spage><epage>654</epage><pages>645-654</pages><issn>1538-7933</issn><issn>1538-7836</issn><eissn>1538-7836</eissn><abstract>Essentials
Russell's viper envenoming is a major health issue in South Asia and causes coagulopathy.
We studied the effect of fresh frozen plasma and two antivenom doses on correcting coagulopathy.
Fresh frozen plasma did not hasten recovery of coagulopathy.
Low‐dose antivenom did not worsen coagulopathy.
Summary
Background
Russell's viper (Daboia russelii) envenoming is a major health issue in South Asia and causes venom‐induced consumption coagulopathy (VICC).
Objectives
To investigate the effects of fresh frozen plasma (FFP) and two antivenom doses in correcting VICC.
Methods
We undertook an open‐label randomized controlled trial in patients with VICC at two Sri Lankan hospitals. Patients with suspected Russell's viper bites and coagulopathy were randomly allocated (1 : 1) to high‐dose antivenom (20 vials) or low‐dose antivenom (10 vials) plus 4 U of FFP. The primary outcome was the proportion of patients with an International Normalized Ratio (INR) of < 2 at 6 h after antivenom administration. Secondary outcomes included anaphylaxis, major hemorrhage, death, and clotting factor recovery.
Results
From 214 eligible patients, 141 were randomized: 71 to high‐dose antivenom, and 70 to low‐dose antivenom/FFP; five had no post‐antivenom blood tests. The groups were similar except for a delay of 1 h in antivenom administration for FFP patients. Six hours after antivenom administration, 23 of 69 (33%) patients allocated to high‐dose antivenom had an INR of < 2, as compared with 28 of 67 (42%) allocated to low‐dose antivenom/FFP (absolute difference 8%; 95% confidence interval − 8% to 25%). Fifteen patients allocated to FFP did not receive it. Severe anaphylaxis occurred equally frequently in each group. One patient given FFP developed transfusion‐related acute lung injury. Three deaths occurred in low‐dose antivenom/FFP patients, including one intracranial hemorrhage. There was no difference in recovery rates of INR or fibrinogen, but there was more rapid initial recovery of factor V and FX in FFP patients.
Conclusion
FFP after antivenom administration in patients with Russell's viper bites did not hasten recovery of coagulopathy. Low‐dose antivenom/FFP did not worsen VICC, suggesting that low‐dose antivenom is sufficient.</abstract><cop>England</cop><pub>Elsevier Limited</pub><pmid>28106331</pmid><doi>10.1111/jth.13628</doi><tpages>10</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1538-7933 |
| ispartof | Journal of thrombosis and haemostasis, 2017-04, Vol.15 (4), p.645-654 |
| issn | 1538-7933 1538-7836 1538-7836 |
| language | eng |
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| source | MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Alma/SFX Local Collection |
| subjects | Adolescent Adult Anaphylaxis Animals Antivenins - therapeutic use antivenoms Blood Coagulation Blood Coagulation Factors - administration & dosage CLINICAL HAEMOSTASIS AND THROMBOSIS Clinical trials consumption coagulopathy Daboia Disseminated Intravascular Coagulation - etiology Disseminated Intravascular Coagulation - therapy Female Hemorrhage Hemorrhage - chemically induced Humans International Normalized Ratio Male Middle Aged Original Plasma Prospective Studies Snake Bites - therapy snake venoms snakebites Sri Lanka Time Factors Treatment Outcome Viper Venoms |
| title | A randomized controlled trial of fresh frozen plasma for coagulopathy in Russell's viper (Daboia russelii) envenoming |
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