Two Different Administration Methods of Tranexamic Acid on Perioperative Blood Loss During Total Hip Arthroplasty
Effects of Two Different Administration Methods of Tranexamic Acid on Perioperative Blood Loss During Total Hip Arthroplasty: a Prospective, Open-label, Randomized, Controlled Clinical Trial
調査の概要
状態
条件
詳細な説明
Background Total hip arthroplasty (THA) is extensively used in various hip diseases. Abundant blood supply at surgical area of bone tissue, intraoperative extensive cleaning, acetabular formation, femoral expansion, and medullary cavity and bone wound bleeding, will lead to extensive intraoperative and postoperative blood loss. The blood transfusion rate is high, which affects patients' rehabilitation. Previous studies have shown that 16%-69% patients required blood transfusion after first THA, which greatly affected patient's rehabilitation, and increased the risk of transfusion-related infection, hemolysis, immunosuppression, acute lung injury, and death. How to reduce perioperative blood loss in total hip arthroplasty has become a hot spot for joint surgeons.
Tranexamic acid as a synthetic antifibrinolytic drug is a synthetic analog of the amino acid lysine. Its mechanisms of action are the competitive inhibition of fibrinolytic zymogens, and noncompetitive inhibition of fibrinolytic enzymes. Tranexamic acid strongly inhibits plasmin-induced fibrin decomposition, reduces fibrinolytic system activity, to achieve local hemostasis and reduce bleeding (Appendix 1). However, the route of administration of tranexamic acid is diverse, and the best way to administer is not clear. A large number of studies have confirmed that during total knee arthroplasty and THA, intravenous application of tranexamic acid can significantly reduce postoperative blood loss, blood transfusion volume and blood transfusion rate. Intra-articular application of tranexamic acid can reduce the drainage volume of drainage tube, total blood loss, blood transfusion volume and blood transfusion rate after joint arthroplasty. Moreover, hemoglobin levels remarkably increase after surgery. More and more studies and meta-analysis have verified that tranexamic acid has a "target effect". Reasonable use of tranexamic acid does not increase the risk of deep venous thrombosis or pulmonary embolism after hip and knee arthroplasties. Simultaneously, tranexamic acid has a good potency ratio.
Adverse events
- To record adverse events during follow up, including incision pain, infection, hip pain, peripheral nerve injury, pulmonary embolism, lower extremity hematoma, deep vein thrombosis, and fixator falling off.
- If severe adverse events occur, investigators would report details, including the date of occurrence and measures taken to treat the adverse events, to the principle investigator and the institutional review board within 24 hours.
Data collection, management, analysis, open access
- Data collection: Case report forms were collected and processed using Epidata software (Epidata Association, Odense, Denmark). These data would be recorded electronically.
- Data management: Tengzhou Central People's Hospital, China would preserve all of the data regarding this trial. Only the project manager has the right to query the database file. This arrangement will not be altered.
- Data analysis: A professional statistician would statistically analyze the electronic database and create an outcome analysis report. An independent data monitoring committee would supervise and manage the trial data.
- Data open access: Anonymized trial data will be published at www.figshare.com.
Statistical analysis
- Statistical analysis would be performed using SPSS 19.0 software (IBM, Armonk, NY, USA) and would follow the intention-to-treat principle.
- Normally distributed measurement data would be expressed as means ± standard deviation and minimums and maximums. Non-normally distributed measurement data would be expressed as the lower quartile (q1) and median and upper quartiles (q3). Count data would be expressed as a percentage.
- The differences in hidden blood loss, dominant blood loss and mean blood loss in each group at intraoperative, postoperative 1 and 3 days would be compared using two-factor analysis of variance with repeated measures. Paired comparison of intergroup data would be conducted using least significant difference. Blood transfusion rate and incidence of adverse reactions in each group were compared using Pearson X2 test.
- The significance level would be α = 0.05.
研究の種類
入学 (予想される)
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Femoral head necrosis or femoral neck fracture patients undergoing the first unilateral THA
- Bilateral hips with indications for THA in patients with femoral head necrosis, but after arthroplasty on one side, the arthroplasty on the other side will be conducted when choosing a good time and physical condition allows.
- Average age: 62.52 years
- Sex ratio of males to females: 11:19
- Signed informed consent
Exclusion Criteria:
- Coagulation disorders and anemia
- History of infection on the affected extremity
- History of vascular embolization and long-term oral anticoagulant drugs
- Contraindications for tranexamic acid or anticoagulant drugs
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
---|---|
intravenous infusion group
In the tranexamic acid intravenous infusion group (n = 30), 15 mg/kg tranexamic acid diluted in 100 mL physiological saline was intravenously infused at the beginning of the surgery.
After suturing deep fascia, 20 mL of physiological saline was intra-articularly injected.
|
In the tranexamic acid intravenous infusion group (n = 30), 15 mg/kg tranexamic acid diluted in 100 mL physiological saline was intravenously infused at the beginning of the surgery.
After suturing deep fascia, 20 mL of physiological saline was intra-articularly injected.
他の名前:
|
intra-articular injection group
In the tranexamic acid intra-articular injection group (n = 30), 100 mL of physiological saline was intravenously infused at the beginning of the surgery.
After suturing deep fascia, the mixture of 1.5 g tranexamic acid and 20 mL physiological saline was intra-articularly injected.
|
In the tranexamic acid intra-articular injection group (n = 30), 100 mL of physiological saline was intravenously infused at the beginning of the surgery.
After suturing deep fascia, the mixture of 1.5 g tranexamic acid and 20 mL physiological saline was intra-articularly injected.
他の名前:
|
control group
In the control group (n = 30), 100 mL of physiological saline was intravenously infused at the beginning of the surgery.
After suturing deep fascia, 20 mL of physiological saline was intra-articularly injected.
|
In the control group (n = 30), 100 mL of physiological saline was intravenously infused at the beginning of the surgery.
After suturing deep fascia, 20 mL of physiological saline was intra-articularly injected.
他の名前:
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
hidden blood loss
時間枠:at postoperative 1 and 3 days
|
Hidden blood loss was calculated by the circulation volume proposed by Gross, i.e., total erythrocyte loss is equal to preoperative total blood volume × (hematocrit preoperatively - hematocrit postoperatively 3 days).
|
at postoperative 1 and 3 days
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Dominant blood loss
時間枠:at intraoperative, postoperative 1 and 3 days
|
Dominant blood loss includes intraoperative blood loss and postoperative blood loss.
Intraoperative blood loss was quantified by measuring irrigation fluid and weight measurement of surgical sponges.
Postoperative blood loss was quantified by measuring wound drainage volume and weight measurement of surgical sponges.
|
at intraoperative, postoperative 1 and 3 days
|
協力者と研究者
捜査官
- 主任研究者:Zhenyang Hou, Master、Tengzhou Central People's Hospital
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
人工股関節全置換術の臨床試験
-
University of Zurich完了
intravenous infusion groupの臨床試験
-
Massachusetts General HospitalBaxter Healthcare Corporation完了
-
University Hospital, GhentUniversity Ghent募集
-
Centre hospitalier de l'Université de Montréal...University Health Network, Toronto; University of British Columbia; McGill University; University... と他の協力者募集
-
University of HawaiiNational Institute on Minority Health and Health Disparities (NIMHD)完了
-
Julien MaillardUniversity of Geneva, Switzerland; Ecole Polytechnique Fédérale de Lausanne完了
-
Amsterdam UMC, location VUmcRed Cross Hospital Beverwijk完了
-
Northeast Center for Rehabilitation and Brain InjuryProbed Medical USAわからない