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Trial record 64 of 419 for:    TRANEXAMIC ACID

Tranexamic Acid for the Control of Blood Loss at Elective Cesarean Section

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ClinicalTrials.gov Identifier: NCT03710330
Recruitment Status : Recruiting
First Posted : October 18, 2018
Last Update Posted : December 13, 2018
Sponsor:
Information provided by (Responsible Party):
hany farouk, Aswan University Hospital

Brief Summary:

The aim of the study is to determine, out of two doses (a standard and a low dose) compared to placebo, the optimal and minimal dose of an intravenously administered single bolus of tranexamic acid(TA) to reduce blood loss when administered during cesarean section(CS). Tranexamic acid is an antifibrinolytic agent, which causes a reversible and competitive blockade of the lysine binding sites on plasminogen molecules. It is a synthetic analog of the amino acid lysine and its action is to reduce blood loss. TA is widely in use in the field of obstetrics. Both antepartum and postpartum hemorrhage(PPH) is being treated by TA extensively. One study demonstrated for the first time that TA administered to women with overt PPH decreases blood loss and maternal morbidity. Prevention of PPH is another indication where TA has been used. Varied doses of TA ranging from 1 mg/kg to more than 100 mg/kg have been used in various surgeries. Even in studies involving CS, the doses used were either a bolus of 1 gm or 10 mg/kg intravenously.

The dose of 1 g or 10 mg/kg is commonly used prophylactically before CS, Because of the lack of data on lower doses and TA pharmacokinetics, a low 0.5-g dose should be tested.


Condition or disease Intervention/treatment Phase
Cesarean Section Complications Drug: normal saline Drug: 1gm tranexamic acid Drug: 0.5 gm tranexamic acid Phase 4

Detailed Description:

CS was carried out under subarachnoid block using 2-2.5 ml of 0.5% hyperbaric bupivacaine after an informed written consent. Blockade up to T4-T6 level was considered an adequate level of anesthesia. After delivery of the neonate, 20 unit of oxytocin in 500 ml normal saline will begive at the rate of 8 mU/min intravenously.

All consenting patients were recruited as a consecutive series to one of the three study groups of 120 patients each, based on block random allocation protocol. Neither the patient nor the investigator was aware of the group assignment. An anesthesiologist not related to the study prepared the drug for every patient.

Groups were labeled as follows:

Group one (120) - 5 ml of distilled water in 20 ml of 5% dextrose

Group two (120) - TA in the dose of I gm in 20 ml of 5% dextrose

Group three(120) - TA in the dose of 0.5gm in 20 ml of 5% dextrose.

The drug in all the groups was given intravenously over 20 min before skin incision.

Monitoring of the pulse rate, blood pressure, Pulse Oximetry (SpO2) and Electrocardiograph (ECG) was carried out every 2 min up to 10 min of starting the study drug; then every 5 min until the delivery of the baby and thereafter every 15 min until the end of the surgery. Blood loss was measured intra-operatively and postoperatively up to 24 h. All material such as sponges, mops, pads, and drapes were weighed with an electronic weighing scale before and at the end of surgery. A volume of blood in the suction bottle was considered only after the placental delivery, to exclude any amniotic fluid volume. The quantity of intra-operative blood loss (ml) = (weight of the abdominal swabs and drapes after CS − weight of materials prior to CS) + (the volume in the suction bottle after placental delivery in ml). Post-operative blood loss was measured by weighing and numbering the vaginal pads used by the patient after completion of CS 2 hourly up to 6 h and then 6 hourly up to 24 h.

Uterine contractility, placental separation, neonatal condition and any side effect caused by TA will be noted. Intramuscular methylergometrine would be used as a rescue uterotonic treatment when required. Post-operative hemoglobin, hematocrit, serum creatinine, and prothrombin time, values were recorded at 24 h. All the parturients were encouraged to start early leg exercises and ambulation in the post-operative period.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Eligible participants were allocated to one of three groups after induction of general anesthesia and immediately prior to the operation and just before skin incision. Groups were labeled as follows:

Group one (120) - 5 ml of distilled water in 20 ml of 5% dextrose

Group two (120) - TA in the dose of I gm in 20 ml of 5% dextrose

Group three(120) - TA in the dose of 0.5gm in 20 ml of 5% dextrose

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The trial will be appropriately blinded; the participants, outcome assessors and the surgeon performing the procedure will be blinded to the medication type, which will be used.
Primary Purpose: Prevention
Official Title: A Double-blind, Placebo-controlled, Randomized Clinical Trial Comparing a Standard 1gm and a Low Dose 0.5gm IV Tranexamic Acid for the Control of Blood Loss at Elective Cesarean Section
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : March 30, 2020
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: normal saline
the patients receives 110 ml normal saline IV just before skin incision
Drug: normal saline
110 ml normal saline IV just before skin incision
Other Name: placebo comparator

Active Comparator: 1gm tranexamic acid
1 gm tranexamic acid (2 ampoules of Capron 500 mg /5 ml; Cairo, Egypt) intravenous just before skin incision
Drug: 1gm tranexamic acid
1 gm tranexamic acid (2 ampoules of Capron 500 mg /5 ml; Cairo, Egypt) intravenous just before skin incision
Other Name: active comparator

Active Comparator: 0.5 gm tranexamic acid
0.5 gm tranexamic acid (1 ampoule of Capron 500 mg /5 ml; Cairo, Egypt) intravenous just before skin incision
Drug: 0.5 gm tranexamic acid
0.5 gm tranexamic acid (2 ampoules of Capron 500 mg /5 ml; Cairo, Egypt) intravenous just before skin incision
Other Name: active comparator




Primary Outcome Measures :
  1. intraoperative blood loss [ Time Frame: during the operation ]
    amount of blood loss during the operation


Secondary Outcome Measures :
  1. postoperative blood loss [ Time Frame: 6 hours post operative ]
    amount of blood loss 6 hours post operative

  2. Number of participants need of uterotonic [ Time Frame: 24 hours post operative ]
    Number of participants need of extra uterotonic

  3. Number of participants need blood transfusion [ Time Frame: 24 hours post operative ]
    Number of participants need of blood transfusion



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   all pregnant women scheduled for elective cesarean
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: all pregnant women scheduled for elective cesarean -

Exclusion Criteria:

  • Patients with a cardiac, hepatic, renal or thromboembolic disease.
  • patients had an allergy to tranexamic acid

    . -patients who had received platelet antiaggregant such as Aspirin in the week before surgery

  • patient refusing to be a participant

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): NCT03710330


Contacts
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Contact: hany f sallam, md 01022336052 ext 002 hany.farouk@aswu.edu.eg

Locations
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Egypt
Aswan University Recruiting
Aswan, Egypt, 81528
Contact: hany f sallam, md    01092440504 ext 002    nahla.elsayed@aswu.ed.eg   
Sponsors and Collaborators
Aswan University Hospital
Investigators
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Principal Investigator: hany f sallam, md Aswan University Hospital

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Responsible Party: hany farouk, Principal Investigator, Aswan University Hospital
ClinicalTrials.gov Identifier: NCT03710330     History of Changes
Other Study ID Numbers: aswu/276/7/18
First Posted: October 18, 2018    Key Record Dates
Last Update Posted: December 13, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by hany farouk, Aswan University Hospital:
cesarean section
tranexamic acid
postpartum hemorrhage
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants