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

NCT03871452 | Completed DMC

• 1 other identifier: h8w67r3k
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Bleeding Disorder

Keywords

Ankaferd BloodStopper, laceration, bleeding

Outcome Measures

Primary Outcomes (2)

• 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

  1-10 minute

• Repetition of bleeding

  Wounds were monitored for half an hour for bleeding recurrence

  0-30 minute

Secondary Outcomes (1)

• Wound infection

  3-5 days

Other Outcomes (1)

• Suture removal

  8-12 days

Study Arms (2)

ABS in external bleeding

ACTIVE COMPARATOR

Drug Ankaferd Blood Stopper Bleeding control in 10 minutes with ABS

Procedure: Ankaferd Blood Stopper in theTraumatic Bleeding

Repetition of ABS stopped bleeding

ACTIVE COMPARATOR

Repetition of ABS stopped bleeding

Procedure: Ankaferd Blood Stopper in theTraumatic Bleeding

Interventions

Ankaferd Blood Stopper in theTraumatic Bleeding PROCEDURE

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

ABS in external bleeding; Repetition of ABS stopped bleeding

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Haydarpasa Numune Training and Research Hospital: lead

Study Sites (1)

Nazmiye Koyuncu

Istanbul, 0620, Turkey (Türkiye)

Location

Related Publications (8)

• 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.

  PMID: 21194248 RESULT

• 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.

  PMID: 18304416 RESULT

• 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.

  PMID: 19094458 RESULT

• 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.

  PMID: 27263447 RESULT

• 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.

  PMID: 19922917 RESULT

• 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.

  PMID: 20814774 RESULT

• 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.

  PMID: 19936413 RESULT

• 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.

  PMID: 30900196 DERIVED

MeSH Terms

Conditions

Hemostatic Disorders; Lacerations; Hemorrhage

Interventions

ankaferd blood stopper

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Cagatay Nuhoglu, MD

  Haydarpasa Numune Education and Research Hospital/İSTANBUL/TURKEY

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: I don't understand very well.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: specialist of emergency medicine

Model Details: 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

Study Record Dates

• First Submitted: March 5, 2019
• First Posted: March 12, 2019
• Study Start: October 1, 2018
• Primary Completion: October 11, 2018
• Study Completion: October 23, 2018
• Last Updated: March 12, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)