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Trial · Interventional

CompletedNot applicableRegistry data

Intravenous Tranexamic Acid and Intramyometrial Desmopressin Effect on Blood Loss During Laparoscopic Myomectomy.

NCTNCT05517590 (opens ClinicalTrials.gov in a new tab)Other idATADEK-2022/05-33
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Names Desmopressin, does not test it. It appears in the title.

Overview

Status
Completed
Phase
Not applicable
Enrollment
102 participants (actual)
Sponsor
Acibadem University · Other
Design
Randomized · Triple masking
Countries
1 country

Turkey (Türkiye)

Start
1 Sept 2022
Primary completion
30 Apr 2024
Completion
30 Apr 2024
First posted
26 Aug 2022
Last update posted
24 May 2024
Conditions
Leiomyoma, Uterine · Intraoperative Blood Loss

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2022202320242025
  1. N/A

    Intravenous Tranexamic Acid and Intramyometrial Desmopressin Effect on Blood Loss During Laparoscopic Myomectomy.

    NCT05517590

    1 Sept 2022 to 30 Apr 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

To evaluate the effect of intravenous tranexamic acid plus intramyometrial desmopressin administration on perioperative blood loss and blood transfusion need in laparoscopic myomectomy operation.

Interventions

  • Tranexamic acidDrug
  • SalineDrug

Arms2

  • Active comparator

    Tranexamic acid and group (Group I)

    In Group I, 1 gram of tranexamic acid will be diluted into 100 ml of saline solution and administered at a rate of 100 ml/hr 10 minutes before the skin incision time.

  • Placebo comparator

    Saline group (Group II)

    Group II placebo will be administered to the control group, and 100 ml of saline solution will be administered at a rate of 100 ml/hr 10 minutes before the skin incision time.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Perioperative blood loss

    Time frame · At the end of the surgery.

    Registry description

    The amount of perioperative bleeding will be calculated by measuring the blood volume in the suction device and subtracting the irrigation fluid from the total amount.

  2. Preoperative and postoperative hemoglobin change

    Time frame · On postoperative day 0 and day 2

    Registry description

    Preoperative and postoperative hemoglobin values will be recorded.

Secondary outcomes(3)

  1. Need for postoperative blood transfusion

    Time frame · Postoperative day 1

    Registry description

    Patients who received postoperative blood transfusions will be recorded.

  2. Operation time

    Time frame · At the end of the operation.

    Registry description

    Operation time will be recorded.

  3. Postoperative thrombosis symptoms

    Time frame · At postoperative first week and 3rd month.

    Registry description

    Postoperative thrombosis symptoms will be recorded at postoperative first week and 3rd month.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Meta-analysis (pooled) · 2014

2 results

Interventions to reduce haemorrhage during myomectomy for fibroids.

Kongnyuy et al. 2014The Cochrane database of systematic reviewscited by 38

PMID 25125317PMC9017065DOI 10.1002/14651858.cd005355.pub5PUB-25125317

Rights unknown2 results
Source linkSee results (2)

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 60 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Healthy volunteer female patients over the age of 18 who will undergo laparoscopic myomectomy in our clinic will be included in our study. Exclusion Criteria: 1. Patients who are planned to undergo different surgery along with myomectomy 2. Those with a diagnosis and suspicion of malignancy 3. Those with a history of thromboembolic disease 4. Those with cardiac, hepatic or renal disease 5. Those with a body mass index of 30 and above 6. Patients with abnormal coagulation test results 7. Patients using anticoagulants 8. Those who use drugs or diseases that may affect coagulation (serum creatinine \> 1.5 mg/dL) 9. Those allergic to tranexamic acid

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