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The Effectiveness of Ankaferd Blood Stopper in the Management of Traumatic Bleeding

Primary Purpose

Bleeding Disorder

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Ankaferd Blood Stopper in theTraumatic Bleeding
Sponsored by
Haydarpasa Numune Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Bleeding Disorder focused on measuring Ankaferd BloodStopper, laceration, bleeding

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Nazmiye Koyuncu

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

ABS in external bleeding

Repetition of ABS stopped bleeding

Arm Description

Drug Ankaferd Blood Stopper Bleeding control in 10 minutes with ABS

Repetition of ABS stopped bleeding

Outcomes

Primary Outcome Measures

Bleeding control
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
Repetition of bleeding
Wounds were monitored for half an hour for bleeding recurrence

Secondary Outcome Measures

Wound infection
They were invited for a follow-up visit 3 days later for wound infection

Full Information

First Posted
March 5, 2019
Last Updated
March 10, 2019
Sponsor
Haydarpasa Numune Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03871452
Brief Title
The Effectiveness of Ankaferd Blood Stopper in the Management of Traumatic Bleeding
Official Title
Haydarpaşa Numune Education and Research Hospital
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
October 11, 2018 (Actual)
Study Completion Date
October 23, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Haydarpasa Numune Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
Detailed Description
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. Statistical analysis was conducted by using the MedCalc Statistical Software version 12.7.7 (MedCalc Software bvba, Ostend, Belgium; http://www.medcalc.org; 2013). Descriptive statistics were used to define continuous variables in this study (mean, standard deviation, range, and median). Mann Whitney U test was used to compare two independent and abnormally distributed groups. Chi-square test was performed to compare categorical variables, or Fisher's Exact test was performed where appropriate or required. Statistical significance level was determined as p<0.05.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bleeding Disorder
Keywords
Ankaferd BloodStopper, laceration, bleeding

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
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
Masking
None (Open Label)
Masking Description
I don't understand very well.
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ABS in external bleeding
Arm Type
Active Comparator
Arm Description
Drug Ankaferd Blood Stopper Bleeding control in 10 minutes with ABS
Arm Title
Repetition of ABS stopped bleeding
Arm Type
Active Comparator
Arm Description
Repetition of ABS stopped bleeding
Intervention Type
Procedure
Intervention Name(s)
Ankaferd Blood Stopper in theTraumatic Bleeding
Intervention Description
ankaferd blood stpper 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
Primary Outcome Measure Information:
Title
Bleeding control
Description
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
Time Frame
1-10 minute
Title
Repetition of bleeding
Description
Wounds were monitored for half an hour for bleeding recurrence
Time Frame
0-30 minute
Secondary Outcome Measure Information:
Title
Wound infection
Description
They were invited for a follow-up visit 3 days later for wound infection
Time Frame
3-5 days
Other Pre-specified Outcome Measures:
Title
Suture removal
Description
Suture removal date was recorded in data collection form.
Time Frame
8-12 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adult patients (18 years-old and above) presented with isolated cuts on the extremities cuts sized between 1 and 5 centimeters . Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cagatay Nuhoglu, MD
Organizational Affiliation
Haydarpasa Numune Education and Research Hospital/İSTANBUL/TURKEY
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nazmiye Koyuncu
City
Istanbul
ZIP/Postal Code
0620
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21194248
Citation
Beyazit Y, Kurt M, Kekilli M, Goker H, Haznedaroglu IC. Evaluation of hemostatic effects of Ankaferd as an alternative medicine. Altern Med Rev. 2010 Dec;15(4):329-36.
Results Reference
result
PubMed Identifier
18304416
Citation
Goker H, Haznedaroglu IC, Ercetin S, Kirazli S, Akman U, Ozturk Y, Firat HC. Haemostatic actions of the folkloric medicinal plant extract Ankaferd Blood Stopper. J Int Med Res. 2008 Jan-Feb;36(1):163-70. doi: 10.1177/147323000803600121.
Results Reference
result
PubMed Identifier
19094458
Citation
Ucar Albayrak C, Caliskan U, Haznedaroglu IC, Goker H. Haemostatic actions of the folkloric medicinal plant extract Ankaferd Blood Stopper. J Int Med Res 2008; 36:163-170. J Int Med Res. 2008 Nov-Dec;36(6):1447-8; author reply 1448-9. No abstract available.
Results Reference
result
PubMed Identifier
27263447
Citation
Ozel Demiralp D, Haznedaroglu IC, Akar N. Functional proteomic analysis of Ankaferd(R) Blood Stopper. Turk J Haematol. 2010 Jun 5;27(2):70-7. doi: 10.5152/tjh.2010.03.
Results Reference
result
PubMed Identifier
19922917
Citation
Tuncer I, Doganay L, Ozturk O. Instant control of fundal variceal bleeding with a folkloric medicinal plant extract: Ankaferd Blood Stopper. Gastrointest Endosc. 2010 Apr;71(4):873-5. doi: 10.1016/j.gie.2009.08.021. Epub 2009 Nov 17. No abstract available.
Results Reference
result
PubMed Identifier
20814774
Citation
Ozaslan E, Purnak T, Yildiz A, Haznedaroglu IC. Bleeding due to slippage of elastic band during variceal ligation: successful use of Ankaferd blood stopper. Indian J Gastroenterol. 2010 Jul;29(4):166-8. doi: 10.1007/s12664-010-0043-y. Epub 2010 Sep 3.
Results Reference
result
PubMed Identifier
19936413
Citation
Al B, Yildirim C, Cavdar M, Zengin S, Buyukaslan H, Kalender ME. Effectiveness of Ankaferd blood stopper in the topical control of active bleeding due to cutaneous-subcutaneous incisions. Saudi Med J. 2009 Dec;30(12):1520-5.
Results Reference
result
PubMed Identifier
30900196
Citation
Koyuncu N. The Effectiveness of Ankaferd Blood Stopper in the Management of Traumatic Bleeding. Adv Ther. 2019 May;36(5):1143-1149. doi: 10.1007/s12325-019-00935-4. Epub 2019 Mar 21.
Results Reference
derived

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The Effectiveness of Ankaferd Blood Stopper in the Management of Traumatic Bleeding

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