跳至主要内容
临床试验/NCT03101124
NCT03101124已完成2 期

Serum Concentration of Tranexamic Acid After Topical Administration in Massive Weight Loss Skin Reducing Surgery

St. Olavs Hospital1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2017年5月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
36
试验地点
1
主要终点
Serum concentration of tranexamic acid

研究概览

简要总结

Tranexamic acid is a drug that prevents clotted blood from dissolving and hence reduces bleeding. It is routinely given intravenously in many surgical situations where there is a risk of major bleeding. Concerns regarding possible adverse effects from intravenous use prevents a more widespread use, even in smaller surgeries. Topical application - using the drug directly on the wound surface- may give a higher concentration at the site of bleeding but a lower concentration in the rest of the body, and hence a lower risk of adverse effects. Here it will be investigated to what extent a defined dose of the drug is absorbed systemically - into the blood stream - when it is applied topically. This will then be compared to the concentration in the blood stream when administered intravenously. Blood samples will be obtained at defined time intervals after administration from patients receiving topical and patients receiving intravenous administration of the same single dose of tranexamic acid. Will less of the drug enter the blood stream if it is applied directly to the wound?

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • planned for major skin reduction surgery (abdominoplasty/panniculectomy) after massive weight loss, or
  • planned for orthopaedic hip replacement surgery

排除标准

  • pregnancy
  • breastfeeding
  • known allergy to tranexamic acid/Cyklokapron®
  • ongoing or former thromboembolic event
  • known kidney failure, as defined by estimated glomerular filtration rate (eGFR)<60 ml/min

研究组 & 干预措施

abdominoplasty moistening

Experimental

Tranexamic Acid 25 mg/ml for wound surface moistening prior to wound closure

干预措施: Tranexamic Acid 25 mg/ml for wound surface moistening (Drug)

abdominoplasty bolus

Experimental

Tranexamic Acid 5 mg/ml as bolus in wound cavity after wound closure

干预措施: Tranexamic Acid 5 mg/ml as bolus in wound cavity (Drug)

preoperative intravenous administration

Active Comparator

Tranexamic Acid Injectable Solution administered before hip replacement surgery

干预措施: Tranexamic Acid Injectable Solution (Drug)

结局指标

主要结局

Serum concentration of tranexamic acid

时间窗: 24 hours

as described by the Area Under the (time-concentration) Curve (AUC) from 0 to infinity, alternatively from 0 to 240 minutes if drug levels after 24 hours do not allow for such extrapolation

次要结局

  • Timepoint for maximum serum concentration (Tmax)(24 hours)
  • AUC from 0 to 240 min(24 hours)
  • Maximum concentration (Cmax)(24 hours)
  • Elimination half-life(24 hours)
  • Adverse events(1 day)

研究者

发起方
St. Olavs Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

终止
4 期
TXA in the Reduction of Post-Op Hematoma and Seroma in Patients Undergoing Panniculectomy or AbdominoplastyPanniculectomyAbdominoplasty
NCT04902950The Reading Hospital and Medical Center9
进行中(未招募)
不适用
Transamin's benefit in decreasing blood loss in knee prosthesis patientsTranexamic acidhemorrhageblood transfusionblood volumeD02.241.223.268.860C23.550.414E02.095.135G09.188.130
RBR-4dvhtsFundacao Hospital Adriano Jorge
Unknown
3 期
Use of Transexamic Acid in Hip ReplacementBleedingTransfusion Related Complication
NCT02587845Samsung Medical Center150
进行中(未招募)
1 期
Study to determine tranxamic acid's effect on the bleedings that occurs within the haemorrhagic caesareaHaemorrhagic ceasereanMedDRA version: 18.1Level: LLTClassification code 10036418Term: Postpartum hemorrhageSystem Organ Class: 100000004868
EUCTR2015-002499-26-FRCentre Hospitalier Régional et Universitaire de Lille342
进行中(未招募)
1 期
Research about the administration of an intravenous drug (trantexamic acid)in order to reduce the amount of trasnsfusion in patients suffering femur fracture. An experiment involving patients is designed: two groups of patients are created by chance allocation, in one the tranexamic acid is administered and in the other an innert substance. After that we compare the amount of blood cell bags needed.Bleeding in patients suffering femur neck fractureMedDRA version: 20.1Level: LLTClassification code 10053220Term: Hip injurySystem Organ Class: 100000004863
EUCTR2018-000528-32-ESConsorci Mar Parc de Salut de Barcelona (Parc de Salut Mar)276