Bleeding DisorderNCT03871452
The Effectiveness of Ankaferd Blood Stopper in the Management of Traumatic Bleeding
A study testing Ankaferd Blood Stopper in theTraumatic Bleeding in people with Bleeding Disorder, run by Haydarpasa Numune Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bleeding Disorder
- What is being tested?
- Ankaferd Blood Stopper in theTraumatic Bleeding
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2018to 23 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients (18 years-old and above)
- presented with isolated cuts on the extremities
- cuts sized between 1 and 5 centimeters .
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Haydarpaşa Numune Education and Research Hospital
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
Read the 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.
- Conditions
- Bleeding Disorder
- Being tested
- Ankaferd Blood Stopper in theTraumatic Bleeding
- Keywords
- Ankaferd BloodStopper, laceration, bleeding
- Medical subject headings
- Hemostatic Disorders, Lacerations, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ankaferd Blood Stopper in theTraumatic BleedingProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| ABS in external bleeding | Active comparator | Drug Ankaferd Blood Stopper Bleeding control in 10 minutes with ABS Receives: Procedure: Ankaferd Blood Stopper in theTraumatic Bleeding |
| Repetition of ABS stopped bleeding | Active comparator | Repetition of ABS stopped bleeding Receives: Procedure: Ankaferd Blood Stopper in theTraumatic Bleeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1-10 minute
Repetition of bleeding
Wounds were monitored for half an hour for bleeding recurrence
Measured: 0-30 minute
Secondary outcomes (1)
Wound infection
They were invited for a follow-up visit 3 days later for wound infection
Measured: 3-5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start1 Oct 2018
- Primary completion11 Oct 2018
- Study completion23 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Bleeding DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- 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)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haydarpasa Numune Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, nazmiye koyuncu, Haydarpasa Numune Training and Research Hospital
- Investigators
- Cagatay Nuhoglu, MD, Principal investigator, Haydarpasa Numune Education and Research Hospital/İSTANBUL/TURKEY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03871452
- Sponsor's protocol ID
- h8w67r3k
- Status last verified
- Mar 2019
- First submitted
- 5 Mar 2019
- Last updated
- 12 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21194248Goker 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.
PubMed 18304416Ucar 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.
PubMed 19094458Ozel 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.
PubMed 27263447Tuncer 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.
PubMed 19922917Ozaslan 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.
PubMed 20814774Al 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.
PubMed 19936413Koyuncu 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.
PubMed 30900196
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Haydarpaşa Numune Education and Research Hospital
- ClinicalTrials.gov ID
- NCT03871452
- Acronym / sponsor ID
- h8w67r3k
- Conditions
- Bleeding Disorder
- Keywords
- Ankaferd BloodStopper, laceration, bleeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Haydarpasa Numune Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 11 Oct 2018 (actual)
- Study completion
- 23 Oct 2018 (actual)
- First posted
- 12 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| ABS in external bleeding | Active comparator | Procedure: Ankaferd Blood Stopper in theTraumatic BleedingDrug Ankaferd Blood Stopper Bleeding control in 10 minutes with ABS |
| Repetition of ABS stopped bleeding | Active comparator | Procedure: Ankaferd Blood Stopper in theTraumatic BleedingRepetition of ABS stopped bleeding |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients (18 years-old and above)
- presented with isolated cuts on the extremities
- cuts sized between 1 and 5 centimeters .
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ankaferd Blood Stopper in theTraumatic Bleedingankaferd 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 | Procedure or surgery | ABS in external bleeding, Repetition of ABS stopped bleeding |
Primary outcome
Bleeding control
Time frame: 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
Repetition of bleeding
Time frame: 0-30 minute
Wounds were monitored for half an hour for bleeding recurrence
1 secondary outcome
Wound infection
Time frame: 3-5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2019.
- Results publication: PubMed 21194248Beyazit 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 publication: PubMed 18304416Goker 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 publication: PubMed 19094458Ucar 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 publication: PubMed 27263447Ozel 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 publication: PubMed 19922917Tuncer 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 publication: PubMed 20814774Ozaslan 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 publication: PubMed 19936413Al 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.
- Derived from this study: PubMed 30900196Koyuncu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cagatay Nuhoglu, MD principal investigator
Haydarpasa Numune Education and Research Hospital/İSTANBUL/TURKEY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ankaferd Blood Stopper in theTraumatic Bleeding in people with Bleeding Disorder, run by Haydarpasa Numune Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bleeding control (time frame: 1-10 minute). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03871452, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2019.