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Thrombin Generation and Platelet Activation in CRS/HIPEC

NCT03034850 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 27

Last updated 2017-01-27

No results posted yet for this study

Summary

Cytoreductive surgery (CRS) with hyperthermic intraperitoneal peroperative chemotherapy (HIPEC), indicated for patients with peritoneal metastases from digestive or gynecological malignancies alike, demonstrates a considerable impact on hemostatic metabolism, both on platelet and on coagulation level. The potential hemostatic interference in CRS and HIPEC is phase dependent. This study demonstrates the combined use of ROTEM (rotational thromboelastometry), PACT (platelet activation test) and CAT (thrombin generation test) assays during CRS and HIPEC with a follow-up of 7 days postoperative.

Conditions

  • Mesothelioma; Peritoneum
  • Pseudomyxoma Peritonei
  • Peritoneal Carcinomatosis

Interventions

PROCEDURE

CRS/HIPEC

The generic surgical approach involved peritonectomy procedures and visceral resections called CRS as described by Sugarbaker (1995). Peritoneal disease burden was assessed using the perito- neal cancer index (PCI), which scores 13 intra-abdominal sites on a scale of 0 (no disease) to 3 (lesion size \> 5 cm), thus giving a range of possible scores from 0 to 39. The same team performed the surgical procedure of all included patients. Before connection to the patient, the circuit was filled with dextrose 5% (2 L/m2 body surface area) and warmed to 37°C.

Sponsors & Collaborators

  • Ziekenhuis Oost-Limburg

    lead OTHER

Principal Investigators

  • Sven Van Poucke, MD · Ziekenhuis Oost-Limburg

Eligibility

Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2016-07-31
Completion
2016-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03034850 on ClinicalTrials.gov