Lundin, E.S., Johansson, T., Zachrisson, H., Leandersson, U., Backman, F., Falknas, L., & Kjolhede, P. (2014). Single-dose tranexamic acid in advanced ovarian cancer surgery reduces blood loss and transfusions: Double-blind placebo-controlled randomized multicenter study. Acta Obstetricia Et Gynecologica Scandinavica, 93(4), 335–344. 

DOI Link

Study Purpose

To compare a single-dose infusion of tranexamic acid with a placebo given IV before the surgery of advanced ovarian cancer to compare blood loss and need for packed red blood cell (PRBC) transfusions

Intervention Characteristics/Basic Study Process

The patients were randomized via computer to receive either tranexamic acid or normal saline (0.9% NaCl) prepared by the local pharmacy. The amount of tranexamic acid of 15 mg/kg in 100 ml of normal saline or the same volume of placebo was administered. The infusion of the medication/placebo was administered via IV 15–20 minutes prior to surgery immediately after general anesthesia was established. A single dose of prophylactic antibiotic was given prior to surgery to all patients as well as 28 days of low-molecular heparin for 28 days postoperation. Hospital staff and patients were blinded to the treatment received. Perioperative bleeding was managed by established clinical protocol and blood transfusions were given during surgery or postoperatively if hemoglobin was below 90 g/L. A single dose of TA 1,000 mg or desmopressin (0.3 µg/kg body weight) was administered if deemed necessary by the surgeon. Drainage was allowed. Postoperative blood and plasma transfusions were given based on the patient’s clinical presentation and hemoglobin level. Hemoglobin levels were assessed five days after surgery or on the day of discharge if it was earlier. Patients were interviewed by a nurse five weeks after surgery.

Sample Characteristics

  • N = 93
  • MEDIAN AGE = 63.75 years (range = 33–90 years)
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Ovarian cancer, surgical patients

 

Setting

  • SITE: Multi-site  
  • SETTING TYPE: Inpatient  
  • LOCATION: Sweden

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

Multi-center, randomized, double-blind, placebo-controlled trial

Measurement Instruments/Methods

Outcomes measured were blood loss amount and total of red blood cell transfusions. Blood loss was assessed with drains, sponges, and drapes. Total blood loss was based on the hemoglobin balance method.

Results

The overall results of the study showed that the total blood loss volume and the transfusion rate were lower in the tranexamic group using a single dose of tranexamic acid. Total blood loss p = 0.03 and transfusions given p = 0.02.

Conclusions

The evidence does suggest that using tranexamic acid immediately before surgery reduces blood loss and the need for transfusions as a prophylactic measure. However, one needs to take into consideration that the strength of this study may need to be further analyzed due to the lack of homogeneity in the participants and the validity of the measuring tools.

Limitations

  • Key sample group differences that could influence results
  • Measurement validity/reliability questionable
  • Other limitations/explanation: There is some concern that not all the women had advanced ovarian cancer and did not undergo an extensive debulking surgery. Also, the measurement tool of sponges and drapes used for blood loss volume can be very subjective in reporting amounts.

Nursing Implications

Given the fact that this medication is reasonably inexpensive and has no serious adverse side effects, nurses need to be aware that this intervention may decrease blood loss and subsequently the need for transfusions.