Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 18 of 419 for:    TRANEXAMIC ACID

Serum Concentration of Tranexamic Acid After Topical Administration in Massive Weight Loss Skin Reducing Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03101124
Recruitment Status : Completed
First Posted : April 4, 2017
Last Update Posted : August 19, 2019
Sponsor:
Collaborator:
Aleris Helse
Information provided by (Responsible Party):
St. Olavs Hospital

Brief Summary:
Tranexamic acid is a drug that prevents clotted blood from dissolving and hence reduces bleeding. It is routinely given intravenously in many surgical situations where there is a risk of major bleeding. Concerns regarding possible adverse effects from intravenous use prevents a more widespread use, even in smaller surgeries. Topical application - using the drug directly on the wound surface- may give a higher concentration at the site of bleeding but a lower concentration in the rest of the body, and hence a lower risk of adverse effects. Here it will be investigated to what extent a defined dose of the drug is absorbed systemically - into the blood stream - when it is applied topically. This will then be compared to the concentration in the blood stream when administered intravenously. Blood samples will be obtained at defined time intervals after administration from patients receiving topical and patients receiving intravenous administration of the same single dose of tranexamic acid. Will less of the drug enter the blood stream if it is applied directly to the wound?

Condition or disease Intervention/treatment Phase
Surgical Wound Bleeding Drug: Tranexamic Acid 25 mg/ml for wound surface moistening Drug: Tranexamic Acid 5 mg/ml as bolus in wound cavity Drug: Tranexamic Acid Injectable Solution Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 12 participants will be included in each of 3 groups: wound moistening group (skin reduction surgery), wound bolus group (after skin reduction surgery), and (for comparison) a group getting usual intravenous tranexamic acid before orthopedic surgery. It is not possible to conduct a formal power calculation, as it is completely unknown which concentrations could be expected after topical use; however, these concentrations are expected to be considerably lower than after intravenous use. Consequently, it is expected that the AUC values in all subjects in the topical (skin reducing surgery) group are far lower than in all subjects in the intravenous (orthopaedic surgery) group. 12 subjects is therefor considered an appropriate number.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Serum Concentration of Tranexamic Acid After Topical Administration in Massive Weight Loss Skin Reducing Surgery
Actual Study Start Date : May 1, 2017
Actual Primary Completion Date : February 28, 2018
Actual Study Completion Date : February 28, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: abdominoplasty moistening
Tranexamic Acid 25 mg/ml for wound surface moistening prior to wound closure
Drug: Tranexamic Acid 25 mg/ml for wound surface moistening
Wound surface moistened with 20 ml of tranexamic acid 25 mg/ml (total dose 500 mg) prior to wound closure
Other Name: Cyclokapron

Experimental: abdominoplasty bolus
Tranexamic Acid 5 mg/ml as bolus in wound cavity after wound closure
Drug: Tranexamic Acid 5 mg/ml as bolus in wound cavity
200 ml of tranexamic acid 5 mg/ml (total dose 1 g) as a bolus instilled into the wound cavity after wound closure, which will remain in the cavity until the activation of drains one hour later
Other Name: Cyclokapron

Active Comparator: preoperative intravenous administration
Tranexamic Acid Injectable Solution administered before hip replacement surgery
Drug: Tranexamic Acid Injectable Solution
1 g of tranexamic acid administered intravenously in accordance with prevailing routines directly prior to planned surgical procedure.
Other Name: Cyclokapron




Primary Outcome Measures :
  1. Serum concentration of tranexamic acid [ Time Frame: 24 hours ]
    as described by the Area Under the (time-concentration) Curve (AUC) from 0 to infinity, alternatively from 0 to 240 minutes if drug levels after 24 hours do not allow for such extrapolation


Secondary Outcome Measures :
  1. AUC from 0 to 240 min [ Time Frame: 24 hours ]
    if AUC from 0 to infinity turns out to be the primary end point.

  2. Maximum concentration (Cmax) [ Time Frame: 24 hours ]
    Maximal level of serum tranexamic acid in measurements

  3. Timepoint for maximum serum concentration (Tmax) [ Time Frame: 24 hours ]
    Timepoint for serum tranexamic acid read from AUC

  4. Elimination half-life [ Time Frame: 24 hours ]
    Reading elimination half-life from AUC

  5. Adverse events [ Time Frame: four weeks ]
    Possible adverse reactions or other complaints observed or reported by the patient - telephone interview

  6. Adverse events [ Time Frame: 1 day ]
    Possible adverse reactions or complaints observed or reported on the first postoperative day - clinical observation



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • planned for major skin reduction surgery (abdominoplasty/panniculectomy) after massive weight loss, or
  • planned for orthopaedic hip replacement surgery

Exclusion Criteria:

  • pregnancy
  • breastfeeding
  • known allergy to tranexamic acid/Cyklokapron®
  • ongoing or former thromboembolic event
  • known kidney failure, as defined by estimated glomerular filtration rate (eGFR)<60 ml/min

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): NCT03101124


Locations
Layout table for location information
Norway
St Olavs Hospital
Trondheim, Norway
Sponsors and Collaborators
St. Olavs Hospital
Aleris Helse
Investigators
Layout table for investigator information
Study Director: Birger Henning Endreseth, MD PhD St Olavs University Hospital

Publications of Results:
Layout table for additonal information
Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT03101124     History of Changes
Other Study ID Numbers: 270778
2016-004246-28 ( EudraCT Number )
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by St. Olavs Hospital:
Hemostasis, Surgical
Tranexamic Acid
Antifibrinolytic Agents
Administration, Cutaneous
Administration, Intravenous
Administration, Topical
Additional relevant MeSH terms:
Layout table for MeSH terms
Tranexamic Acid
Weight Loss
Surgical Wound
Body Weight Changes
Body Weight
Signs and Symptoms
Wounds and Injuries
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants