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Trial record 59 of 419 for:    TRANEXAMIC ACID

Topical Tranexamic Acid in Caesarean Section (TXACS)

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ClinicalTrials.gov Identifier: NCT02492087
Recruitment Status : Unknown
Verified March 2016 by Dr Meng-Li Lee, Ministry of Health, Malaysia.
Recruitment status was:  Recruiting
First Posted : July 8, 2015
Last Update Posted : March 16, 2016
Sponsor:
Collaborator:
Ministry of Health, Malaysia
Information provided by (Responsible Party):
Dr Meng-Li Lee, Ministry of Health, Malaysia

Brief Summary:
The objective of this study is to investigate whether topical application of tranexamic acid into the uterine cavity and the surgical site intra-operatively can reduce blood loss and provide better surgical haemostasis in parturients with moderate to high risk for bleeding undergoing caesarean deliveries.

Condition or disease Intervention/treatment Phase
Postpartum Haemorrhage Drug: Topical tranexamic acid Drug: Normal saline 0.9% Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Prophylactic Use of Topical Tranexamic Acid to Aid Surgical Haemostasis During Caesarean Sections in Parturients With Moderate to High Risk of Bleeding
Study Start Date : August 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Tranexamic acid (TXA) Group
Subjects in the TXA group will receive the topical tranexamic acid solution which will be administered intra-operatively, during the caesarean section on the surgical wound and into the intrauterine cavity after the delivery of the baby and the placenta. 60mls of the solution will be applied topically to the placental bed as identified by the surgeon carrying out the surgery by spraying the study solution using a syringe into the uterine cavity. Another 30mls of the solution will be applied to the open incision wound. The surgeon will then proceed to close the first layer of the uterus in the usual manner. The remaining 30mls of the study drug solution is then applied topically on the closed incision wound
Drug: Topical tranexamic acid
Topical tranexamic acid 2g diluted with normal saline 0.9% to a volume of 120mls solution (Concentration 16.7mg/ml)
Other Name: TXA group

Sham Comparator: Control Group
Subjects in the Control group will receive topical normal saline solution which will be administered intra-operatively in the same manner as described for the TXA group.
Drug: Normal saline 0.9%
Sterile Normal saline 0.9% 120mls solution
Other Name: Control group




Primary Outcome Measures :
  1. Total intra-operative blood loss in the Tranexamic Acid (TXA) group compared to the Control group [ Time Frame: From the start of the surgery (first surgical incision) up to the end of the surgery (at wound closure) ]

    Total intra-operative blood loss will be measured at the end of the surgery (at wound closure).

    The following formula will be used:

    Total intra-operative blood loss (ml) = A + B - C where A = Blood volume in suction bottle (ml) B = Wet weight of all gauzes and drapes soaked with blood (g) C = Dry weight of all gauzes and drapes soaked with blood (g) (assumption of 1 gram of blood is equivalent to 1ml of blood) The blood loss quantified will be documented in subjects case report form



Secondary Outcome Measures :
  1. Transfusion requirements in terms of number of red blood cell packets transfused up to 24 hours post surgery [ Time Frame: From start of surgery (first surgical incision) up to 24 hours post surgery (wound closure) ]
    The number of red blood cell packets (number of pints) transfused in all patients from the start of the surgery up to 24 hours post surgery will be documented in each subject's case report form and the transfusion requirements will be compared between both groups.

  2. Haematocrit trends at baseline (Pre-operative) and at 6 hours post surgery in the TXA group and the Control group [ Time Frame: Pre-operatively within 24 hours prior to start of surgery (before surgical incision) up to 6 hours from the end of surgery (wound closure) ]
    Subjects full blood count will be taken pre-operatively within 24 hours prior to start of surgery (baseline) and at 6 hours from the end of the surgery (wound closure) to measure the haematocrit trends in both study groups and these values will be documented in the case report form



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Parturients aged more than 18 years old
  2. American Society of Anesthesiologists (ASA) physical status class 1 to 3
  3. Parturients planned for caesarean sections (both emergency and elective) under regional anaesthesia
  4. Parturients who have increased risks of bleeding during caesarean deliveries as follows:

Moderate Risk for Bleeding

  • Induction of labour
  • Prolonged labour >12 hours
  • Large baby > 4kg
  • Pyrexia in labour
  • Age > 40 years (not multiparous)
  • Obesity (BMI >35)
  • Anaemia (Hb < 9g/dl)
  • Multigravida
  • Previous history of PPH
  • Previous scars

High Risk for Bleeding

  • Known bleeding disorders (congenital or acquired)
  • Multiple pregnancies
  • Preeclampsia and pregnancy induced hypertension
  • Placenta praevia
  • Placenta accreta/increta/percreta
  • Placenta abruption

Exclusion Criteria:

  1. Parturients who have an urgent/emergency indication for caesarean sections where timing of the operation may be critical in determining the maternal and/or foetal outcomes
  2. Patients who are planned for caesarean sections under general anaesthesia
  3. Patients who are already clinically bleeding prior to surgery
  4. Parturients who received blood transfusion within 48 hours prior to the caesarean section
  5. Patients with known allergy to tranexamic acid
  6. Patients with clear contraindications for tranexamic acid (e.g. thromboembolic event, history of convulsions)
  7. Patients with severe renal failure with creatinine clearance <10

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02492087


Contacts
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Contact: Meng-Li Lee, FANZCA +60165550499 leemengli@yahoo.com
Contact: Mohd Rohisham Zainal Abidin, MMed Anaes +60122190123 drmrza@yahoo.com

Locations
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Malaysia
Hospital Tengku Ampuan Rahimah Recruiting
Klang, Selangor, Malaysia, 41200
Contact: Ming Fei Lee, MMed Anaes    +60126197404    lmingfei@yahoo.com   
Contact: Mohd Rohisham Zainal Abidin, MMed Anaes    +60122190123    drmrza@yahoo.com   
Sub-Investigator: Mohamad Farouk Abdullah, MSurg Obst         
Sponsors and Collaborators
Dr Meng-Li Lee
Ministry of Health, Malaysia
Investigators
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Principal Investigator: Meng-Li Lee, FANZCA Department of Anaesthesia, Hospital Tengku Ampuan Rahimah, Ministry of Health, Malaysia

Additional Information:
Publications:

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Responsible Party: Dr Meng-Li Lee, Specialist Anaesthetist, Ministry of Health, Malaysia
ClinicalTrials.gov Identifier: NCT02492087     History of Changes
Other Study ID Numbers: NMRR-14-1034-20129
First Posted: July 8, 2015    Key Record Dates
Last Update Posted: March 16, 2016
Last Verified: March 2016
Keywords provided by Dr Meng-Li Lee, Ministry of Health, Malaysia:
topical
tranexamic acid
haemostasis
caesarean section
bleeding
postpartum hemorrhage
prophylactic
Additional relevant MeSH terms:
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Tranexamic Acid
Postpartum Hemorrhage
Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Pharmaceutical Solutions
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants