Table 8.

Case Reports Addressing Dabigatran Reversal in Human Subjects

	Garber 201284	Truumees 201285	Wychowski 201286	Warkentin 201287	Cano 201288
Patient Characteristics	83- year old male	72- year old male	66- year old female	79- year old male	78- year old female
Disease	Intracranial hemorrhage	Epidural hematoma	Upper GI bleeding	Massive post-operative bleeding	Severe coagulopathy and bleeding
Decreased Renal	Not reported	Not reported	Yes	Yes	Yes
Function
Anticoagulant	Dabigatran	Dabigatran	Dabigatran	Dabigatran	Dabigatran
Drug
Coagulation assays measured after intervention	No	Yesa	INR, aPTT, TT	aPTT, INR, fibrinogen, TT	PT, aPTT, INR
Length of drug therapy prior to intervention	One month	Unknown	2 months	Unknown	Unknown
Reversal Intervention(s)	rFVIIa (dose not given)	2mg rFVIIa, 5 units FFP, 6 units RBC	3 units RBC, 5mg IV vitK, PCCsb25 units/kg and 50 units/kg, dialysis	Tranexamic acid, protamine, cryoprecipitate, FFP, platelets, 3 doses rFVIIa (2.4 mg/dose), 2 doses rFVIIa (7.2 mg/dose), hemodialysis	Multiple blood products, PCCs, dialysisc
Outcome	Hemorrhage expanded and patient died shortly after.	FFP and rFVIIa had little effect on coagulopathy and did not reduce hemorrhage.	Coagulation assays and bleeding were corrected. Patient remained hemodialysis-dependent and died 2 months later.	High-dose rFVIIa combined with hemodialysis was effective in managing bleeding.	Coagulopathy and bleeding persisted. Patient died 5 days later.

FFP = fresh frozen plasma; PCCs = prothrombin complex concentrates; rFVIIa = recombinant factor VIIa; RBC = red blood cells; vitK = vitamin K; PT = prothrombin time; aPTT = activated partial thromboplastin time; TT = thrombin clotting time; ECT = ecarin clotting time; INR = international normalized ratio.

^aSpecific coagulation assays not given.

^bThree-factor PCCs.

^cSpecifics on dose and types of blood products were not given.

Dabigatran was given as 150 mg twice a day.