Clinical trial • Phase IV • Other

TRANEXAMIC ACID for Postoperative bleeding | Surgical wound complications

Phase IV trial of TRANEXAMIC ACID for Postoperative bleeding | Surgical wound complications.

Overview

Trial Therapeutic Area
Other
Trial Disease
Postoperative bleeding | Surgical wound complications
Trial Stage
Phase IV
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
30-05-2024
First CTIS Authorization Date
19-06-2024

Trial design

Randomised, cyklokapron (tranexamic acid) — single topical administration (dose/schedule not specified in provided documents); comparator: 0.9% sodium chloride (placebo) — topical (dose/schedule not specified).-controlled Phase IV trial across 14 sites in Norway, Finland, Denmark.

Randomised
Yes
Comparator
Cyklokapron (tranexamic acid) — single topical administration (dose/schedule not specified in provided documents); Comparator: 0.9% sodium chloride (placebo) — topical (dose/schedule not specified).
Target Sample Size
3500
Trial Duration For Participant
30

Eligibility

Recruits 3500 Vulnerable population not selected; participants must be over 18 and capable of independently providing informed consent; informed-consent form must be signed..

Vulnerable Population
Vulnerable population not selected; participants must be over 18 and capable of independently providing informed consent; informed-consent form must be signed.

Inclusion criteria

  • {"criterion_text":"- Patients are to undergo a surgical procedure within the field of plastic surgery where the procedure involves use of topical TXA at the participating center."}
  • {"criterion_text":"- Patients are over 18 years of age and capable of independently providing informed consent."}
  • {"criterion_text":"- Patients have received adequate oral and written information about the study and signed the informed-consent form ."}

Exclusion criteria

  • {"criterion_text":"- Patients with known allergy to tranexamic acid."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Given one or several of the following occurrences, re-bleeding will be defined as “yes”: Re-operation, surgical exploration or evacuation, aspiration, blood transfusion or external extra compression due to hematoma within the first postoperative 10 days","definition_or_measurement_approach":"Re-bleeding is defined as 'yes' if any of the listed occurrences occur within the first 10 postoperative days (re-operation, surgical exploration or evacuation, aspiration, blood transfusion or external extra compression due to hematoma)."}

Secondary endpoints

  • {"endpoint_text":"- Postoperative wound infection: Infection within the first 30 days requiring any of the following: Extra outpatient follow-up, re-operation, or revision or antibiotic treatment.","definition_or_measurement_approach":"Occurrence of wound infection within 30 days requiring extra outpatient follow-up, re-operation, revision or antibiotic treatment."}
  • {"endpoint_text":"- Postoperative wound rupture: Wound rupture within the first 30 days requiring any of the following: Extra outpatient follow-up, re-operation, or revision.","definition_or_measurement_approach":"Occurrence of wound rupture within 30 days requiring extra outpatient follow-up, re-operation or revision."}
  • {"endpoint_text":"- Thromboembolic events defined as thrombophlebitis, deep venous thrombosis, pulmonary embolus, cerebral or coronary infarctions until 30 days postoperatively.","definition_or_measurement_approach":"Occurrence of specified thromboembolic events (thrombophlebitis, DVT, PE, cerebral or coronary infarctions) up to 30 days postoperatively."}
  • {"endpoint_text":"- Seroma defined as the need for aspiration of fluids, or spontaneous evacuation of voluminous fluids, between 10 and 30 days postoperatively.","definition_or_measurement_approach":"Seroma identified by need for aspiration or spontaneous evacuation of voluminous fluids between postoperative days 10 and 30."}
  • {"endpoint_text":"- Other possible adverse effects causing contact with the health service until 30 days postoperatively.","definition_or_measurement_approach":"Any other adverse effects leading to contact with health services within 30 days postoperatively."}

Recruitment

Planned Sample Size
3500
Recruitment Window Months
54
Consent Approach
Participants must be over 18 and capable of independently providing informed consent; an informed-consent form must be signed. Subject information and ICF documents are available in multiple languages (documents include English, Finnish, Swedish, Norwegian, Danish versions).

Geography

Total Number Of Sites
14
Total Number Of Participants
3500

Norway

Earliest CTIS Part Ii Submission Date
27-05-2024
Latest Decision Or Authorization Date
20-03-2026
Processing Time Days
662
Number Of Sites
12
Number Of Participants
3000

Sites

Site Name
Helse Moere Og Romsdal HF
Department Name
Molde, Department of surgery
Contact Person Name
Christian Busch
Contact Person Email
christian.busch@helse-mr.no
Site Name
Universitetssykehuset Nord-Norge HF
Department Name
Department of plastic- and reconstructive surgery, Clinic of Surgery
Contact Person Name
Thomas Sjøberg
Contact Person Email
thomas.sjoberg@unn.no
Site Name
Sykehuset Ostfold HF
Department Name
Department of surgery, Section of plastic surgery
Contact Person Name
Lars Frich
Contact Person Email
larsfrich@hotmail.com
Site Name
Oslo University Hospital HF
Department Name
Divison of Plastic and Reconstructive Surgery, Clinic of Surgery
Contact Person Name
Ane Bøyum Opheim
Site Name
Helse Bergen HF
Department Name
Surgical department
Contact Person Name
Stian Kreken Almeland
Site Name
St. Olavs Hospital HF
Department Name
Department of plastic- and reconstructive surgery
Contact Person Name
Kjersti Ausen
Contact Person Email
Kjersti.ausen@stolav.no
Site Name
Vestre Viken HF
Department Name
Department of Surgery
Contact Person Name
Ane Bøyum Opheim
Site Name
Sykehuset Innlandet HF
Department Name
Hamar, Department of plastic- and reconstructive surgery
Contact Person Name
Lene Oskal
Site Name
Sykehuset Innlandet HF
Department Name
Tynset, Department of Plastic and Reconstructive Surgery
Contact Person Name
Gudjon L. Gunnarsson
Contact Person Email
gudjonleifur@yahoo.com
Site Name
Sykehuset Telemark HF
Department Name
Department of hand, plastic -and reconstructive surgery
Contact Person Name
Wenche Hegard
Contact Person Email
weolse@sthf.no
Site Name
Helse Stavanger HF
Department Name
Department of Plastic Surgery
Contact Person Name
Kristin Furholt
Contact Person Email
kristin.ochoa.furholt@sus.no
Site Name
Haraldsplass Diakonale Sykehus AS
Department Name
Department of Plastic Surgery and Burns
Contact Person Name
Hildur Skuladottir

Finland

Earliest CTIS Part Ii Submission Date
26-02-2025
Latest Decision Or Authorization Date
27-03-2025
Processing Time Days
29
Number Of Sites
1
Number Of Participants
200

Sites

Site Name
HUS-Yhtymae
Department Name
Department of Pastic Surgery
Contact Person Name
Susanna Kauhanen
Contact Person Email
susanna.kauhanen@hus.fi

Denmark

Earliest CTIS Part Ii Submission Date
09-09-2025
Latest Decision Or Authorization Date
14-09-2025
Processing Time Days
5
Number Of Sites
1
Number Of Participants
300

Sites

Site Name
Lillebaelt Hospital
Department Name
Department of Plastic Surgery
Contact Person Name
Tine Engberg Damsgaard

Sponsor

Primary sponsor

Full Name
St. Olavs Hospital HF
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Norway

Investigational products

Investigational Product Name
Cyklokapron 100 mg/ml injeksjons-/infusjonsvæske, oppløsning
Active Substance
TRANEXAMIC ACID
Modality
Small molecule
Routes Of Administration
TOPICAL
Route
Topical
Authorisation Status
Authorised (marketing authorisation present in NO)
Frequency
Single topical administration (single dose)
Maximum Dose
500 mg
Investigational Product Name
CHLORURE DE SODIUM 0,9 % LAVOISIER, solution pour perfusion
Active Substance
SODIUM CHLORIDE
Modality
Small molecule
Routes Of Administration
TOPICAL
Route
Topical
Authorisation Status
Authorised
Frequency
Single topical administration (placebo)
Maximum Dose
5 ml

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