Do coagulation factor concentrates improve haemostasis and survival in dabigatran-associated haemorrhage?
Date First Published:
November 1, 2014
Last Updated:
November 2, 2014
Report by:
Dylan James Mac Lochlainn, Medical Student (University College London)
Three-Part Question:
In [patients with dabigatran-associated haemorrhage] do [coagulation factor concentrates] improve [haemostasis and survival]?
Search Strategy:
Medline (1966/01/01 to 2014/11/01) was searched using the Pubmed database.
Search Details:
"Blood Coagulation Factors/therapeutic use"[Mesh] OR "Blood Coagulation Factors/therapy"[Mesh] ) AND (dabigatran OR pradaxa)
Filters: Humans, English
Filters: Humans, English
Outcome:
48 items returned, of which 5 were relevant.
Relevant Paper(s):
| Study Title | Patient Group | Study type (level of evidence) | Outcomes | Key results | Study Weaknesses |
|---|---|---|---|---|---|
| Activated prothrombin complex concentrate for dabigatran-associated bleeding. Schulman S, Ritchie B, Goy JK, Nahirniak S, Almutawa M, Ghanny S. 2013 Canada | 4 patients (ages: 81-85) with daibagtran-associated bleeding (gastrointestinal; pericaridal; subdural; intraxial) treated with aPCC (FEIBA) | Case series | Resolution of bleeding | 04-Apr | Limited case series. |
| Survival | 04-Apr | ||||
| Use of prothrombin complex concentrates for urgent reversal of dabigatran in the Emergency Department. Díaz MQ, Borobia AM, Núñez MA, Virto AM, Fabra S, Casado MS, García-Erce JA, Samama CM. 2013 Spain | 5 patients (ages: 77-88) with daibagtran-associated gastrointestinal bleeding treated with PCC (Octaplex), one of whom also received Vitamin K. | Case series | Resolution of bleeding | 04-May | Limited case series. |
| Survival | 04-May | ||||
| Life-threatening bleeding in four patients with an unusual excessive response to dabigatran: implications for emergency surgery and resuscitation. Lillo-Le Louët A, Wolf M, Soufir L, Galbois A, Dumenil AS, Offenstadt G, Samama MM. 2012 France | 4 patients (ages: 72-86) with dabigatran-associated bleeding, 3 of whom recevied FFP and CFC preparations (PCC (Kaskadil) & rFVIIa; rFVIIa; PCC (Kanokad) & rFVIIa). Of these 3, one patient also received haemodiafiltration. |
Case series. | Resolution of bleeding | 0/2 | Limited case series. The contribution of coagulation factor concentrates could only be assessed in 2 of 3 patients, as one patient also received haemodiafiltration. |
| Survival | 0/2 | ||||
| Reversal of dabigatran-induced bleeding with a prothrombin complex concentrate and fresh frozen plasma. Dumkow LE, Voss JR, Peters M, Jennings DL. 2012 USA | 85 year-old man with dabigaran-associated gastrointestinal bleeding treated with FFP and PCC (Factor IX complex) | Case study | Resolution of bleeding | 01-Jan | Limited case study. |
| Survival | 0/1 | ||||
| Reversing dabigatran in life-threatening bleeding occurring during cardiac ablation with factor eight inhibitor bypassing activity. Dager WE, Gosselin RC, Roberts AJ. 2013 USA | 67 year-old man with dabigatran-associated bleeding secondary to a transseptal perforation during cardiac ablation was treated with aPCC (FEIBA) | Case study | Resolution of bleeding | 01-Jan | Limited case study. |
| Survival | 01-Jan |
Author Commentary:
Currently, there is no antidote available for dabigatran. The role of several coagulation factor concentrates in reversing dabigatran has been investigated, but the evidence for their efficacy in acute haemorrhage is limited to case series and studies.
Bottom Line:
There is insufficient clinical evidence at present for the efficacy of any coagulation factor concentrate in the treamnent of dabigatran-associated bleeding.
References:
- Schulman S, Ritchie B, Goy JK, Nahirniak S, Almutawa M, Ghanny S.. Activated prothrombin complex concentrate for dabigatran-associated bleeding.
- Díaz MQ, Borobia AM, Núñez MA, Virto AM, Fabra S, Casado MS, García-Erce JA, Samama CM.. Use of prothrombin complex concentrates for urgent reversal of dabigatran in the Emergency Department.
- Lillo-Le Louët A, Wolf M, Soufir L, Galbois A, Dumenil AS, Offenstadt G, Samama MM.. Life-threatening bleeding in four patients with an unusual excessive response to dabigatran: implications for emergency surgery and resuscitation.
- Dumkow LE, Voss JR, Peters M, Jennings DL.. Reversal of dabigatran-induced bleeding with a prothrombin complex concentrate and fresh frozen plasma.
- Dager WE, Gosselin RC, Roberts AJ.. Reversing dabigatran in life-threatening bleeding occurring during cardiac ablation with factor eight inhibitor bypassing activity.