Analysis of coagulation factor XIII as a predictor of postoperative complications after reconstructive surgery in patients following massive weight loss.

Analysis of coagulation factor XIII as a predictor of postoperative complications after reconstructive surgery in patients following massive weight loss. - FXIIIinWHO

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00032149

Enrollment

168

Registered

2023-07-12

Start date

2022-01-01

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

L98.7

Interventions

Group 1: Measurement of factor XIII activity in postbariatric patients with indication for reconstructive surgery at the following time points: - Pre-operative - 2 days postoperatively - 5 days postop

Eligibility

Sex/Gender

All

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Initially, all patients should have had a body mass index (BMI) of = 40 kg/m² and currently have a BMI below 35 kg/m² for the planned surgery. Patients in the control group Upper extremity fracture (excluding carpus or hand fractures) and a stable BMI of < 35 kg/m² in the past 12 months (no changes of 5% or more in body weight). In differentiation from the first group, these must not have had a BMI of = 40 kg/m² in the past.

Exclusion criteria

Exclusion criteria: - Patients during pregnancy and lactation - Hypersensitivity to the active substance factor XIII - Hypersensitivity to heparin - Known coagulation disorder - Current anticoagulation - Termination of anticoagulation less than 6 months ago

Design outcomes

Primary

Measure	Time frame
Measurement of factor XIII activity (%) at the following time points: - Pre-operative - 2 days postoperatively - 5 days postoperatively For this laboratory analysis, a total collection of one citrate tube (3.0 ml) of whole blood is required at all three time points. Factor XIII activity is determined by the BCS XP system (Siemens Healthcare GmbH, Erlangen, Germany) using the assay Berichrom® Factor XIII (Siemens Healthcare).	—

Measure

Time frame

Measurement of factor XIII activity (%) at the following time points: - Pre-operative - 2 days postoperatively - 5 days postoperatively For this laboratory analysis, a total collection of one citrate tube (3.0 ml) of whole blood is required at all three time points. Factor XIII activity is determined by the BCS XP system (Siemens Healthcare GmbH, Erlangen, Germany) using the assay Berichrom® Factor XIII (Siemens Healthcare).

—

Secondary

Measure	Time frame
In the course of the post-operative and post-inpatient follow-up of patients, the occurrence of major (i. e. indication for surgical revision due to a wound healing disorder, a hematoma or seroma, and puncture of a hematoma or seroma; %) and minor complications (i. e. conservative wound management to promote healing of corresponding wounds, no indication for surgical revision of a hematoma or seroma; %) is recorded in the documentation form.	—

Measure

Time frame

In the course of the post-operative and post-inpatient follow-up of patients, the occurrence of major (i. e. indication for surgical revision due to a wound healing disorder, a hematoma or seroma, and puncture of a hematoma or seroma; %) and minor complications (i. e. conservative wound management to promote healing of corresponding wounds, no indication for surgical revision of a hematoma or seroma; %) is recorded in the documentation form.

—

Countries

Germany

Contacts

Public ContactHeiko Sorg

Marien Hospital Witten

who@elisabethgruppe.de+4923021733040

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026