Low risk of haematomas with intramuscular vaccines in anticoagulated patients: a systematic review with meta-analysis
Abstract Introduction The summary of product characteristics of vaccines administered intramuscularly, including the vaccine for coronavirus SARS-CoV-2 (COVID-19) and Influenza, warned for risks of bleeding in patients treated with oral anticoagulants. We aimed to estimate the incidence of major ble...
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| Format: | Article |
| Language: | English |
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BMC
2022-02-01
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| Series: | Thrombosis Journal |
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| Online Access: | https://doi.org/10.1186/s12959-022-00367-1 |
| _version_ | 1819280739361882112 |
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| author | Daniel Caldeira Bárbara Sucena Rodrigues Mariana Alves Fausto J. Pinto Joaquim J. Ferreira |
| author_facet | Daniel Caldeira Bárbara Sucena Rodrigues Mariana Alves Fausto J. Pinto Joaquim J. Ferreira |
| author_sort | Daniel Caldeira |
| collection | DOAJ |
| description | Abstract Introduction The summary of product characteristics of vaccines administered intramuscularly, including the vaccine for coronavirus SARS-CoV-2 (COVID-19) and Influenza, warned for risks of bleeding in patients treated with oral anticoagulants. We aimed to estimate the incidence of major bleeding events in this setting and to compare these risks against other vaccination routes. Methods This systematic review included all prospective and retrospective studies enrolling anticoagulated patients that received intramuscular vaccination, published until December 2020 in CENTRAL, MEDLINE and EMBASE. The outcomes of interest were major bleeding and haematoma related with vaccination. The incidence of the outcomes was estimated through a random-effects meta-analysis using the Freeman-Turkey transformation. The results are expressed in percentages, with 95%-confidence intervals (95%CI), limited between 0 and 100%. When studies compared intramuscular vaccination vs. other route, the data were compared and pooled using random-effects meta-analysis. Risk ratios (RR) with 95%CI were reported. Results Overall 16 studies with 642 patients were included. No major bleeding event was reported. The pooled incidence of haematomas following vaccination (mostly against Influenza) in patients treated with oral anticoagulants (mostly warfarin; no data with DOACs / NOACs) was 0.46% (95%CI 0-1.53%). Three studies evaluated the intramuscular vs. subcutaneous route of vaccination. Intramuscular vaccines did not increase the risk of haematoma (RR 0.53, 95%CI 0.10-2.82) compared with subcutaneous route. Conclusions Intramuscular vaccination in anticoagulated patients is safe with very low incidence of haematomas and the best available evidence suggests that using the intramuscular route does not increase the risk of haematomas compared with the subcutaneous route. |
| first_indexed | 2024-12-24T00:48:35Z |
| format | Article |
| id | doaj.art-07edb921f3af452f9de80405de971dbc |
| institution | Directory Open Access Journal |
| issn | 1477-9560 |
| language | English |
| last_indexed | 2024-12-24T00:48:35Z |
| publishDate | 2022-02-01 |
| publisher | BMC |
| record_format | Article |
| series | Thrombosis Journal |
| spelling | doaj.art-07edb921f3af452f9de80405de971dbc2022-12-21T17:23:38ZengBMCThrombosis Journal1477-95602022-02-012011810.1186/s12959-022-00367-1Low risk of haematomas with intramuscular vaccines in anticoagulated patients: a systematic review with meta-analysisDaniel Caldeira0Bárbara Sucena Rodrigues1Mariana Alves2Fausto J. Pinto3Joaquim J. Ferreira4Laboratory of Clinical Pharmacology and Therapeutics, Faculdade de Medicina, Universidade de LisboaFaculdade de Medicina da Universidade de LisboaLaboratory of Clinical Pharmacology and Therapeutics, Faculdade de Medicina, Universidade de LisboaCentro Cardiovascular da Universidade de Lisboa - CCUL, CAML, Faculdade de Medicina, Universidade de LisboaLaboratory of Clinical Pharmacology and Therapeutics, Faculdade de Medicina, Universidade de LisboaAbstract Introduction The summary of product characteristics of vaccines administered intramuscularly, including the vaccine for coronavirus SARS-CoV-2 (COVID-19) and Influenza, warned for risks of bleeding in patients treated with oral anticoagulants. We aimed to estimate the incidence of major bleeding events in this setting and to compare these risks against other vaccination routes. Methods This systematic review included all prospective and retrospective studies enrolling anticoagulated patients that received intramuscular vaccination, published until December 2020 in CENTRAL, MEDLINE and EMBASE. The outcomes of interest were major bleeding and haematoma related with vaccination. The incidence of the outcomes was estimated through a random-effects meta-analysis using the Freeman-Turkey transformation. The results are expressed in percentages, with 95%-confidence intervals (95%CI), limited between 0 and 100%. When studies compared intramuscular vaccination vs. other route, the data were compared and pooled using random-effects meta-analysis. Risk ratios (RR) with 95%CI were reported. Results Overall 16 studies with 642 patients were included. No major bleeding event was reported. The pooled incidence of haematomas following vaccination (mostly against Influenza) in patients treated with oral anticoagulants (mostly warfarin; no data with DOACs / NOACs) was 0.46% (95%CI 0-1.53%). Three studies evaluated the intramuscular vs. subcutaneous route of vaccination. Intramuscular vaccines did not increase the risk of haematoma (RR 0.53, 95%CI 0.10-2.82) compared with subcutaneous route. Conclusions Intramuscular vaccination in anticoagulated patients is safe with very low incidence of haematomas and the best available evidence suggests that using the intramuscular route does not increase the risk of haematomas compared with the subcutaneous route.https://doi.org/10.1186/s12959-022-00367-1BleedingHaemorrhageVaccineFlu, anticoagulation |
| spellingShingle | Daniel Caldeira Bárbara Sucena Rodrigues Mariana Alves Fausto J. Pinto Joaquim J. Ferreira Low risk of haematomas with intramuscular vaccines in anticoagulated patients: a systematic review with meta-analysis Thrombosis Journal Bleeding Haemorrhage Vaccine Flu, anticoagulation |
| title | Low risk of haematomas with intramuscular vaccines in anticoagulated patients: a systematic review with meta-analysis |
| title_full | Low risk of haematomas with intramuscular vaccines in anticoagulated patients: a systematic review with meta-analysis |
| title_fullStr | Low risk of haematomas with intramuscular vaccines in anticoagulated patients: a systematic review with meta-analysis |
| title_full_unstemmed | Low risk of haematomas with intramuscular vaccines in anticoagulated patients: a systematic review with meta-analysis |
| title_short | Low risk of haematomas with intramuscular vaccines in anticoagulated patients: a systematic review with meta-analysis |
| title_sort | low risk of haematomas with intramuscular vaccines in anticoagulated patients a systematic review with meta analysis |
| topic | Bleeding Haemorrhage Vaccine Flu, anticoagulation |
| url | https://doi.org/10.1186/s12959-022-00367-1 |
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