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. Author manuscript; available in PMC: 2016 Sep 15.
Published in final edited form as: Cochrane Database Syst Rev. 2016 Mar 15;3:CD009733. doi: 10.1002/14651858.CD009733.pub3

Table 3. Results of studies (secondary outcomes of review).

Study Type of
study		 Number of
participants		 Type of
participants		 Mortality
(all causes)		 Mortality
(secondary to
bleeding)		 Mortality
(secondary to
thromboembolism)		 Laboratory
assessment of
fibrinolysis		 Number of
platelet
transfusions		 Number of
red cell
components		 Adverse
events of
antifibrinolytic
agents		 Adverse
events of
transfusions
(e.g. transfusion
reactions,
antibody
development)		 DIC QoL
Tranexamic acid studies
Avvisati 1989 RCT 12 APML NR NR NR No difference in the coagulation and fibrinolysis indices between the 2 groups apart from FDPs a. FDPs decreased in TXA arm but increased in the placebo arm (P < 0. 01) Platelet Tx TXA = 45 Tx C = 246 Tx

(P = 0. 045)		 Reduction in overall RBC components required in TXA group: (units) TXA = 28 C = 56 (P = 0. 016) NR NR NR NR
Shpilberg 1995 RCT 56 AML 38 induction 18 consolidation NR No fatal bleeding in either group NR NR Induction (units) TXA 22.1 SD 13. 2 C 23.1 SD 11. 7 Consolidation (units) TXA 3.7 SD 4.1 C 9.3 SD 3.3 (P < 0. 05) No reduction RBC transfusion requirements Induction (units) TXA 7.5 SD 4.7 C 7.3 SD 3.3 Consolidation (units) TXA 4.1 SD 2.8 C 4.1 SD 3.4 No side effects were observed NR NR NR
EACA studies
Gallardo 1983 RCT 19 15 AML
4 ALL		 NR NR No participant died of thrombosis Monitored with the I125 fibrinogen plasma clot lysis assay but no further data described EACA 1 every 13.3 days at riskb

Placebo 1 every 10.5 days at riskb 		NR Side effects were stated as minimal NR NR NR
a

Blood coagulation tests were prothrombin time, activated partial thromboplastin time, fibrinogen, FDP, antithrombin III activity, thrombin-antithrombin III complexes, protein C activity and α2-antiplasmin. These were carried out daily for the first 10 days.

b

Days at risk defined as days when platelet count fewer than 20 × 109/L.

ALL: acute lymphoblastic leukaemia

AML: acute myeloid leukaemia

APML: acute promyelocytic leukaemia

C: control

DIC: intravascular coagulation

EACA: epsilon aminocaproic acid

FDPs: fibrin degradation products

GI: gastrointestinal

GU: genitourinary

QoL: quality of life

NR: not reported

RBC: red blood cell

RCT: randomised controlled trial

SD: standard deviation

TXA: tranexamic acid

Tx: transfusion