跳至主要内容
临床试验/NCT03871452
NCT03871452已完成不适用

Haydarpaşa Numune Education and Research Hospital

Haydarpasa Numune Training and Research Hospital2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2018年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
2
主要终点
Repetition of bleeding

研究概览

简要总结

The objective of this study was to prospectively compare effectiveness of Ankaferd Blood Stopper (ABS) with dry sponges in cessation of bleeding in adult trauma cases with external bleeding due to extremity lacerations.

Methods: The study was conducted on patients with bleeding associated with extremity lacerations. All consecutive patients presented to the emergency department of the high-volume training hospital in Istanbul were recruited within the study period

详细描述

This study was planned as a prospective randomized study. After local ethics committee approval, all consecutive patients admitted to the Emergency Department of the Haydarpasa Numune Training & Research Hospital due to extremity lacerations between October 1st and October 11th 2018 were recruited. The longest duration for wound healing, infection follow-up, and suture removal was 12 days. Therefore, the study was completed in a total of 23 days after suture removal of the last case.

ABS which was approved in 2017 by the Ministry of Health, is being used routinely in the management of the patients with traumatic bleeding in the emergency department of the hospital. Nurses working in treatment areas of the department were trained for this prospective study. They were trained to apply compression of approximately 3-kg weight after irrigation with saline in patients with active bleeding who met inclusion criteria. Bleeding was controlled in every minute and data were collected. Traditional methods such as primary suturing were performed in patients whose bleeding did not stop within 10 minutes. Patients whose bleeding was stopped were monitored for half an hour for bleeding recurrence.

The patients were divided into two groups; ones treated by ABS soaked wet compresses (group I) and ones treated by dry sponge compresses (group II). Demographic data, systemic disease history, drugs used, injury mechanism, habits etc. of the patients enrolled in the study were recorded into data collection form.

Forty commercially prepared ABS-soaked wet sterile sponges and 40 dry sponges of 2.5x7 cm were randomly numbered and placed in a box in the study area. Random numbers table was used to generate the sequence of enumeration of the sponges. Any given patient was treated with the next sponge with the smallest number in the box and data sheets contained the number of the sponge with which the patient's bleeding was intervened. Therefore, allocation concealment was accomplished for the study purposes.

In both groups, lacerations that did not stop bleeding within 10 minutes and lacerations with recurred bleeding within the half-hour follow-up period were repaired by the primary suturing. Lacerations were sutured at the end of follow-up period in other patients. Daily dressing was recommended to the patients at discharge, and they were invited for a follow-up visit 3 days later. They were followed-up for wound infection. Suture removal date was recorded in data collection form.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Health Services Research
盲法
None

盲法说明

I don't understand very well.

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

  • Adult patients (18 years-old and above)
  • presented with isolated cuts on the extremities
  • cuts sized between 1 and 5 centimeters .

排除标准

  • Patients under 18 years of age
  • with only superficial abrasions
  • with lacerations smaller than 1 cm and larger than 5 cm
  • irregular laceration borders or star-like lacerations
  • deep lacerations requiring subcutaneous suturing
  • lacerations requiring additional interventions such as tendon repair controlled bleeding
  • grade III and IV systemic diseases (advanced heart failure, uncontrolled hypertension, etc.) according to American Society of Anesthesiologists (ASA) classification,
  • who received radiotherapy or chemotherapy for malignancies within the last three months
  • with the history of hematologic diseases such as leukemia
  • using medications leading to hemorrhage risk (oral anticoagulants, aspirin, etc.)
  • congenital coagulation factor deficiency such as hemophilia
  • multiple trauma and abnormal vital signs

研究组 & 干预措施

ABS in external bleeding

Active Comparator

Drug Ankaferd Blood Stopper Bleeding control in 10 minutes with ABS

干预措施: Ankaferd Blood Stopper in theTraumatic Bleeding (Procedure)

Repetition of ABS stopped bleeding

Active Comparator

Repetition of ABS stopped bleeding

干预措施: Ankaferd Blood Stopper in theTraumatic Bleeding (Procedure)

结局指标

主要结局

Repetition of bleeding

时间窗: 0-30 minute

Wounds were monitored for half an hour for bleeding recurrence

Bleeding control

时间窗: 1-10 minute

Group I were compressed with ABS-soaked wet sponge, and group II were treated with compression using dry sterile sponges. The compresses were briefly removed at one-minute intervals and bleeding status were checked. This process was continued for a maximum of 10 minutes. The time when both stopped the bleeding was noted for comparison.The main issue here was to see how long the ABS had taken control of the bleeding

次要结局

  • Wound infection(3-5 days)

研究者

发起方
Haydarpasa Numune Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

nazmiye koyuncu

specialist of emergency medicine

Haydarpasa Numune Training and Research Hospital

研究点 (2)

Loading locations...

相似试验

The Effectiveness of Ankaferd Blood Stopper in the... | 临床试验