Is Intraoperative Use of QuikClot Combat Gauze Effective for Hemostasis after Total Knee Arthroplasty?

This prospective randomized controlled study was performed with the approval of the ethics committee of Kangwon National University Hospital (No. 2015-04-005-002). Eighty-nine knees underwent TKA between July 2015 and January 2016. The inclusion criterion was subjects with osteoarthritis who had normotensive blood pressure regardless of whether they were taking drugs for hypertension. Indications for surgery were grade 4 osteoarthritis of the knee according to the Kellgren and Lawrence grading system.11) The exclusion criteria were subjects with hematologic disease, who showed abnormal bleeding test or coagulation test results preoperatively, anemia, poorly controlled hypertension, posterior cruciate ligament substituting type TKA (PS-TKA), revision TKA, and refusal to participate in the study. Subjects who were taking antithrombotic or anti-fibrinolytic drugs had stopped the medication for 7 days before surgery and restarted after the Hemovac drain was removed. The subjects with normal laboratory results prior to surgery were included and those with abnormal results were excluded. Eighty-five osteoarthritic knees underwent TKA during the study period. Two subjects (2 knees) had abnormal preoperative laboratory test results, one had uncontrolled hypertension, 1 subject (2 knees) refused to participate in the study, and three knees required revision TKA. Thus, 77 knees were enrolled before surgery, and informed consent was obtained from all subjects after the purpose and procedures of this study were explained. However, 17 knees were additionally excluded during surgery as they underwent PSTKA (Fig. 1).

Fig. 1
The Consolidated Standards Of Reporting Trials (CONSORT) flow diagram of this study. TKA: total knee arthroplasty.

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The demographics of the subjects are shown in Table 1. The outcomes were not statistically significantly different between two groups as seen in Table 2. The MCL was completely released during surgery in four knees in group 1 and six knees in group 2 (p = 0.488). The PCL was released at the tibial side in 18 knees in group 1 and in 17 knees in group 2 (p = 0.793). Lateral retinacular release was performed in three knees in group 1 and eight knees in group 2 (p = 0.095). Total bleeding volume was 311.6 ± 147.7 mL in the subjects in whom the MCL was completely released and 318.1 ± 165.0 mL in those in whom the MCL was not completely released (p = 0.908). Total bleeding volume was 310.4 ± 131.2 mL in the subjects in whom the PCL was released and 328.0 ± 204.1 mL in those in whom the PCL was not released (p = 0.684). Total bleeding volume was 325.9 ± 168.1 mL in the subjects in whom the lateral retinaculum was released and 280.3 ± 86.6 mL in those in whom the lateral retinaculum was not released (p = 0.378). No complications were observed in either group.

Table 1
Demographics of the Subjects

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Table 2
Comparisons of Results between Groups 1 and 2

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The most important finding of this study was that QCG was not significantly effective for reducing postoperative hemorrhage after cruciate-retaining type TKA compared with standard gauze. As TKA is becoming one of the most commonly performed orthopedic surgeries, care must be taken regarding potential perioperative complications. TKA is associated with significant perioperative blood loss of up to 2,000 mL after surgery.12, 13) A blood transfusion is often required intra- or postoperatively and transfusion rates range as high as 63%–94%.14, 15) In this study, the mean drainage output volume was 270.1 ± 136.3 mL in group 1 and 349.0 ± 170.6 mL in group 2, and the transfusion rates were 90% in group 1 and 67% in group 2 to maintain a postoperative hemoglobin level of over 10 g/dL. Perioperative anemia and RBC transfusions are associated with increased utilization of healthcare resources, extended hospital stay, delayed recovery, and higher rates of postoperative morbidity and mortality.1, 2) Various techniques have been introduced to reduce blood loss during the perioperative period, and perioperative antifibrinolytic therapy is recommended as part of a comprehensive perioperative blood management strategy.16) However, there is an issue of the risks of antifibrinolytic therapy such as a cerebrovascular accident.17) We used a pneumatic tourniquet during surgery and Hemovac drainage was clamped for the first 3 hours after surgery. We did not use antifibrinolytic therapy in this study.

The trigger hemoglobin level for blood transfusion varies. Many authors recommend blood transfusion in case of hemoglobin level below 8–10 g/dL.18, 19) Tavares Cardozo et al.20) recommended blood transfusions in patients with hemoglobin less than 9 g/dL. Rosencher et al.21) reported that blood transfusion triggered after orthopedic surgery were hemoglobin levels of 8.93 ± 1.83 g/dL in Europe and 21% of these occurred when the hemoglobin level was greater than 10 g/dL. Borghi and Casati22) recommended blood transfusion for a patient with hemoglobin of less than 10 g/dL if the patient had cerebrovascular or coronary artery disease. We set the trigger hemoglobin level to 10 g/dL for blood transfusion and assessed hemoglobin during the first 4 days after surgery. Zhou et al.23) reported that hemoglobin decreased during the first 4 days after arthroplasty and then gradually returned to normal levels within 6–12 weeks postoperatively. We assessed perioperative albumin level, as albumin level has been used as an index of nutritional status, which is associated with hemoglobin level.24, 25)

We think that bone bleeding may significantly affect postoperative blood loss, and no evidence suggests an effect of QCG on postoperative bone bleeding. However, bone bleeding can be minimized by performing cruciateretaining type TKA and sealing the bone cutting surface with bone cement. Additionally, the soft tissue release to balance ligaments, such as MCL, PCL, or lateral retinaculum releases, did not affect perioperative bleeding in this study.

There are several studies favoring QCG over standard gauze regarding the hemostatic effect.26, 27, 28) Abbott et al.26) reported that QCG was more effective in reducing intraoperative blood loss and limiting perioperative transfusion rate than standard gauze in their retrospective study of pediatric spinal deformity surgery. Gegel et al.28) stated that QCG produced a more robust clot that could withstand significant movement than standard gauze in their porcine study. On the other hand, our study revealed that QCG was not more effective than standard gauze for reducing intraoperative bleeding, postoperative drainage, or the perioperative blood transfusion rate. However, our study was performed during routine surgery and not under extreme conditions, such as hemodilution, acidosis, or severance of major vessels.

This study had some limitations. First, QCG was initially invented for hemostasis of major bleeding for cases in which a tourniquet cannot be applied. The entire procedures of the surgery were performed with an inflated tourniquet except during the 5 minutes of gauze application. However, the amount of postoperative bleeding after TKA is mostly significant and postoperative hemostasis has been a matter of concern. Second, no control group, which would have received no gauze packing, was used. Gauze packing for hemostasis may not be routine procedure during TKA; however, we set the control group procedure the same as that of the QCG group. Third, the hemostatic effect of standard gauze and QCG may not be certain as significant time passed after the tissue was injured before the gauze packing was performed. Vasoconstriction, platelet plug formation, and blood coagulation usually occur within several minutes after tissue injury. We released the tourniquet 40 to 50 minutes after beginning the procedure in this study, which would be sufficient for self-hemostasis although the operated limb was exsanguinated.

In conclusions, QCG was not significantly effective for reducing perioperative bleeding volume or the blood transfusion rate compared with standard gauze during cruciate-retaining TKA.