A Phase 4 interventional study of intravenous application of tranexamic acid and Floseal hemostatic matrix in Hip Replacement, Total, sponsored by Chang Gung Memorial Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-18.
Sponsored by Chang Gung Memorial Hospital · Phase 4, Interventional, and Treatment
Total hip arthroplasty (THA) is an excellent surgical procedure for patients with end-stage hip diseases. However, THA is associated with considerable blood loss and increasing needs for allogenic blood transfusion. Tranexamic acid (TXA) was reportedly effective reducing total blood loss (TBL) after standard THA. However, a TBL of one L is still high for elderly patients.
Floseal (Baxter, Deerfield, Illinois), a thrombin-based hemostatic agent, have been widely used in surgical procedure. However, there is no study investigating the effect of Floseal in THA procedures.This study anticipated that combination with the two different mechanism of topical hemostatic agent, Floseal, and intravenous TXA can bring a synergistic blood saving effect in THA patients.
Purpose:
Our purpose of this study therefore is to conduct a prospective randomized controlled trial to investigate the blood-conservation effect of combination of intravenous TXA and topical Floseal in a primary THA procedure.
Material and Methods:
The patients who are enrolled in this study will be assigned into three groups. The first group will be treated by combination of 1 g of TXA pre-operatively and two boluses TXA post-operatively intravenously and Floseal topical application, the second group by 1 g of TXA pre-operatively and two boluses TXA postoperatively intravenously without Floseal use, and the third group was control group which will be treated without TXA and Floseal. This study will observe whether there is difference in the blood-conservation effect by total blood loss calculation, hemoglobin loss and transfusion requirement between these three groups.
This study anticipate that combined use of intravenous TXA and Floseal in THA procedure is more effective in decreasing blood loss and blood transfusion than intravenous TXA application alone, and this formula do not increase the risk of thromboembolic disease.
Chang Gung Memorial Hospital is the lead sponsor of 1,064 studies on the registry; 235 are open to participants now.
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Exclusion Criteria:
Primary total hip replacement with application of Floseal hemostatic matrix on potential bleeding sites after prosthesis implantation, and intravenous application of tranexamic acid1 g TXA before incision, followed by two boluses (1g TXA) three hours later and six hours later
Drug: intravenous application of tranexamic acid · Drug: Floseal hemostatic matrix
Primary total hip replacement with intravenous application of tranexamic acid1 g TXA before incision, followed by two boluses (1g TXA) three hours later and six hours later
Drug: intravenous application of tranexamic acid
Control group, neither TXA nor Floseal® will be used. Equivalent volume of normal saline injection pre- and post-operatively
Drug: Normal saline
intravenous application of tranexamic acid1 g TXA before incision, followed by two boluses (1g TXA) three hours later and six hours later.
Also known as: transamine
application of Floseal® on potential bleeding sites after prosthesis implantation
Also known as: Floseal
Equivalent volume of saline injection before incision, followed by two boluses (1g TXA) three hours later and six hours later.
Also known as: saline
Total Blood Loss
The total blood loss was calculated according to Nadler et al, which uses maximum postoperative decrease of the Hb level adjusted for weight and height of the patient. Total blood loss consists of amount of blood loss calculated from the maximum Hb loss and amount of blood transfused
Time frame: Post op day 4
Acute intraoperative Blood Loss
The intra-operative blood loss was recorded according to the volume of contents of the suction bottle and the estimated blood loss through weighing the swabs. The blood loss volume (ml) will be the volume of contents of the suction plus the increasing weight (gm) of swabs (supposing the proportion of blood is 1 gm/mL)
Time frame: At the end of operation
The change of Hemoglobin level
Check postoperative Hemoglobin level on postoperative day 1,2,4
Time frame: Preoperative day 1 to Post op day 4
Blood transfusion rate
We will record the event of blood transfusion, and calculate the incidence of transfusion
Time frame: Within 3 months after operation
Thrombosis risk evaluation
Detect the presence of deep-vein thrombosis of both lower limbs by duplex ultrasound study before discharge
Time frame: Within 3 months after operation
Incidence of wound complications
Wound complications including hematoma, skin necrosis and infection
Time frame: Within 3 months after operation
Plan to share: Undecided
This study is status unknown, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Chang Gung Memorial Hospital