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临床试验/NCT04514978
NCT04514978进行中(未招募)不适用

The Effect of Blood Donation on Hematological and Iron Indices and Detection of Autologous Blood Transfusion

University of Copenhagen2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2018年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
48
试验地点
2
主要终点
Hemoglobin centration

研究概览

简要总结

Blood donations is a essential and crucial in the clinic. Normal biological variation of relevant biomarkers and hormones before the donation of 450 mL whole blood as well as the expected alterations in systemic levels of plasma iron indices and RBC measures up to 4 weeks after donation in healthy, non-anemic, young men and women is investigated

Likewise, the possibilities for detecting autologous blood transfusion is investigated.

详细描述

Blood donations is a essential and crucial in the clinic. A whole blood donation results in the loss of 450-525 mL whole blood in eight to ten minutes and is known to reduce body iron stores with 200-265 mg iron depending on the donor's age, hematocrit and sex and accounts for 25% of average tissue iron stores in men and up to 75% in women.In the present study, the investigators aimed at thoroughly evaluate normal biological variation of relevant biomarkers and hormones before the donation of 450 mL whole blood as well as the expected alterations in systemic levels of plasma iron indices and red blood cell measures up to 4 weeks after donation in healthy, non-anemic, young men and women

Likewise, doping in sport is a major problem concerning both the health of the athletes and the integrity of sports. Despite major improvements in anti-doping work in recent years, it is still impossible to test for all existing and future doping strategies, such as manipulation with blood oxygen carrying capacity. A well-known doping strategy is autologous blood transfusion (ABT), and at present, the detection of ABT is a challenge for anti-doping authorities. The hypotheses for this study are that 1) ret% and abnormal blood profile score (ABPS) have higher sensitivity to micro-dose ABT compared to current variables in the Athlete Biological Passport (ABP); 2) The plasma concentration of hepcidin and erythroferrone (ERFE) is sensitive to micro-dose ABT; 3) Gender-specific variations in hematologic variables affect the interpretation of the athlete's biological passport.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Triple (Participant, Care Provider, Investigator)

盲法说明

An algorithm was created using randomizer.org

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Relative maximum oxygen uptake (VO2-max) of at least 55 ml O2/min/kg for male participants and 50 ml O2/min/kg for female participants

排除标准

  • Insufficient fitness level
  • Blood donation 3 months prior to enrollment
  • Altitude exposure 2 months before enrollment
  • Hypertension

结局指标

主要结局

Hemoglobin centration

时间窗: 6 days after reinfusion

The effect of the intervention on \[Hb\] levels will be investigated

reticulocyte percentage

时间窗: 6 days after reinfusion

The effect of the intervention on ret% levels will be investigated

Homeostatic markers of iron metabolism

时间窗: 6 days after reinfusion

Markers of iron metabolism such as hepcidin and erythroferrone are collected and analyzed for evaluation of iron metabolism during and after donation and reinfusion of blood.

OFF-score

时间窗: 6 days after reinfusion

The effect of the intervention on OFF-score (an algorithm computed from reticulocyte percentage and hemoglobin concentration resulting in a arbitrary value) will be investigated

次要结局

  • Endurance exercise performance measured as a preloaded 400 kcal time-trial(6 days after reinfusion.)
  • Mean corpuscular concentration(6 days after reinfusion.)
  • Dried Blood Spots(6 days after reinfusion.)
  • Maximal oxugen uptake (VO2max)(6 days after reinfusion.)
  • Mean corpuscular hemoglobin concentration(6 days after reinfusion.)
  • Mean corpuscular volume(6 days after reinfusion.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nikolai Nordsborg

Associate professor, Head of Department

University of Copenhagen

研究点 (2)

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