Tranexamic acid reduces blood loss in patients with extracapsular fractures of the hip: results of a randomised controlled trial

TY - JOUR

T1 - Tranexamic acid reduces blood loss in patients with extracapsular fractures of the hip

T2 - results of a randomised controlled trial

AU - Tengberg, P T

AU - Foss, N B

AU - Palm, H

AU - Kallemose, T

AU - Troelsen, A

N1 - ©2016 The British Editorial Society of Bone & Joint Surgery.

PY - 2016/6

Y1 - 2016/6

N2 - Aims: We chose unstable extra-capsular hip fractures as our study group because these types of fractures suffer the largest blood loss. We hypothesised that tranexamic acid (TXA) would reduce total blood loss (TBL) in extra-capsular fractures of the hip. Patients and Methods: A single-centre placebo-controlled double-blinded randomised clinical trial was performed to test the hypothesis on patients undergoing surgery for extra-capsular hip fractures. For reasons outside the control of the investigators, the trial was stopped before reaching the 120 included patients as planned in the protocol. Results: In all 72 patients (51 women, 21 men; 33 patients in the TXA group, 39 in the placebo group) were included in the final analysis, with a significant mean reduction of 570.8 ml (p = 0.029) in TBL from 2100.4 ml (standard deviation (SD) = 1152.6) in the placebo group to 1529.6 ml (SD = 1012.7) in the TXA group. The 90-day mortality was 27.2% (n = 9) in the TXA group and 10.2% (n = 4) in the placebo group (p = 0.07). We were not able to ascertain a reliable cause of death in these patients. Discussion: TXA significantly reduced TBL in extra-capsular hip fractures, but concerns regarding its safety in this patient group must be investigated further before the use of TXA can be recommended.

AB - Aims: We chose unstable extra-capsular hip fractures as our study group because these types of fractures suffer the largest blood loss. We hypothesised that tranexamic acid (TXA) would reduce total blood loss (TBL) in extra-capsular fractures of the hip. Patients and Methods: A single-centre placebo-controlled double-blinded randomised clinical trial was performed to test the hypothesis on patients undergoing surgery for extra-capsular hip fractures. For reasons outside the control of the investigators, the trial was stopped before reaching the 120 included patients as planned in the protocol. Results: In all 72 patients (51 women, 21 men; 33 patients in the TXA group, 39 in the placebo group) were included in the final analysis, with a significant mean reduction of 570.8 ml (p = 0.029) in TBL from 2100.4 ml (standard deviation (SD) = 1152.6) in the placebo group to 1529.6 ml (SD = 1012.7) in the TXA group. The 90-day mortality was 27.2% (n = 9) in the TXA group and 10.2% (n = 4) in the placebo group (p = 0.07). We were not able to ascertain a reliable cause of death in these patients. Discussion: TXA significantly reduced TBL in extra-capsular hip fractures, but concerns regarding its safety in this patient group must be investigated further before the use of TXA can be recommended.

KW - Aged

KW - Antifibrinolytic Agents

KW - Blood Loss, Surgical

KW - Blood Transfusion

KW - Denmark

KW - Double-Blind Method

KW - Early Termination of Clinical Trials

KW - Female

KW - Fracture Fixation, Intramedullary

KW - Hemoglobins

KW - Hip Fractures

KW - Hospital Mortality

KW - Humans

KW - Male

KW - Tranexamic Acid

KW - Journal Article

KW - Randomized Controlled Trial

UR - http://www.bjj.boneandjoint.org.uk/content/98-B/12/1711.1

U2 - 10.1302/0301-620X.98B6.36645

DO - 10.1302/0301-620X.98B6.36645

M3 - Journal article

C2 - 27235515

SN - 0301-620X

VL - 98-B

SP - 747

EP - 753

JO - The Bone & Joint Journal

JF - The Bone & Joint Journal

IS - 6

ER -